Inclusion Criteria:
* The individual must have received an infusion of gene-modified cells in a completed Kite-sponsored parent study, has not withdrawn full consent, and has discontinued or completed the post-treatment follow-up period in the parent study, as applicable
* The individual must understand and voluntarily sign an Informed Consent Form (ICF) or an Informed Assent Form prior to any study-related assessments or procedures being conducted
* In the investigator's judgment, the individual is willing and able to complete the protocol-required follow-up schedule and comply with the study requirements for participation
Exclusion Criteria: none
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Inclusion Criteria:
* The individual must have been administered gene-modified cell therapy or completed the post-treatment follow-up period in the parent study, as applicable
* The individual must understand and voluntarily sign an Informed Consent Form (ICF) or an Informed Assent Form prior to any study-related assessments or procedures being conducted
* In the investigator's judgment, the individual is willing and able to complete the protocol-required follow-up schedule and comply with the study requirements for participation
Exclusion Criteria: none
Inclusion Criteria:
* Being cisgender Black male
* Being aged ≥ 18 years
* Having Internet access
* Speaking English
* Self-reporting condomless sex with another man in the past 6 months
* HIV negative or untested.
Exclusion Criteria:
* Having lived in the US South less than 3 months
* Having received antiretroviral therapy (ART) treatment.
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Inclusion Criteria:
* Being cisgender Black male
* Being aged ≥ 18 years
* Having Internet access
* Speaking English
* Self-reporting condomless sex with another man in the past 6 months
* Living in the U.S. South
* HIV negative or untested.
Exclusion Criteria:
* Not residing in a U.S. Census Bureau-defined Southern state: AL, AR, DE, FL, GA, KY, LA, MD, MS, NC, OK, SC, TN, TX, VA, WV.
* Having received antiretroviral therapy (ART) treatment.
Key Inclusion Criteria:
Inclusion Criteria for systemic lupus erythematosus (SLE) and lupus nephritis (LN):
* Age ≥ 18 years
* Meet the European Alliance of Associations for Rheumatology (EULAR)- American College of Rheumatology (ACR) 2019 classification criteria for SLE
* Presence of either double-stranded deoxyribonucleic acid (DNA) anti- double-stranded DNA (anti-dsDNA) and/or anti-Smith antibodies at screening per local laboratory.
* Moderate to severe, active disease defined as at least one British Isles Lupus Assessment Group (BILAG-A) score or 2 BILAG B (excluding constitutional and/or neuropsychiatric organ system).
* Refractory to steroids and inadequate response or intolerance to at least 2 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolate mofetil or its derivatives, belimumab, anifrolumab, rituximab, obinutuzumab, methotrexate, azathioprine, cyclosporin, tacrolimus, or voclosporin.
* For LN: Refractory to steroids and inadequate response or intolerance to at least 2 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolate mofetil or its derivatives, belimumab, rituximab, obinutuzumab, azathioprine, cyclosporin, tacrolimus, or voclosporin
Inclusion Criteria for LN:
* Renal biopsy-proven Class III or intravenous (IV) ± V LN according to the revised International Society of Nephrology and Renal Pathology Society (ISN/RPS) criteria within 6 months prior to or during screening
* Evidence of active LN at screening
Inclusion Criteria for systemic sclerosis (SSc):
* Age ≥ 18 years
* Diffuse Systemic Sclerosis (SSc) according to ACR/EULAR 2013 classification criteria with active skin disease and/or progressive SSc-interstitial lung disease (ILD) OR limited SSc with progressive ILD.
* Refractory or intolerance to 1 of the following for a minimum of 3 months and/or contraindication: mycophenolate mofetil or its derivatives, methotrexate, tocilizumab (or other IL-6 inhibitor), rituximab (or other B-cell depleting agent), nintedanib (or other antifibrotic agents), cyclophosphamide.
* High-resolution computer tomography (HRCT) scan and pulmonary function test (PFT) within 3 months prior to screening.
Inclusion Criteria for idiopathic inflammatory myopathy (IIM):
* Age ≥ 18 years
* Probable or definite IIM based on EULAR/ACR 2017 classification (excluding inclusion body myositis).
* Active disease demonstrated by electromyography (EMG), magnetic resonance imaging (MRI) or muscle enzymes
* Moderate to severe disease activity
* Positive for myositis specific antibodies for patients with non-dermatomyostitis IIM
* HRCT scan and PFT within 3 months prior to screening.
* Refractory or intolerance to at least 1 month of glucocorticoids and standardized use of at least 2 immunosuppressant/modulator (eg, intravenous gamma globulins, methotrexate, mycophenolate mofetil and its derivatives, azathioprine, cyclophosphamide, calcineurin inhibitors, Janus kinase (JAK) inhibitors, rituximab or other B-cell depleting agent).
Inclusion Criteria for all Cohorts:
* Adequate hepatic, renal, pulmonary, and cardiac function.
Key Exclusion Criteria:
Exclusion Criteria for all Cohorts:
* Females of childbearing potential who are pregnant or breast feeding.
* Dialysis within the past year.
* History of malignancy, within the last 5 years.
* Hypogammaglobulinemia requiring immunoglobulin replacement.
* History of autologous or allogeneic stem cell transplant and/or organ transplant.
* Prior treatment with cellular therapy, gene therapy and/or T-cell engager therapy.
* Known history of HIV infection, or hepatitis B or C virus infections.
* Active or untreated latent tuberculosis (TB).
* Active or uncontrolled infections.
* Nonspecific, overlap, mixed autoimmune diseases not clearly identified into any of the studied cohorts.
Exclusion Criteria for LN:
* Significant pre-existing damage or rapidly progressive glomerulonephritis (GN).
Exclusion Criteria for SLE:
* Drug-induced SLE.
* Catastrophic antiphospholipid syndrome.
* Thrombotic thrombocytopenic purpura.
* Active or unstable lupus neuropsychiatric manifestations within last 6 months.
Exclusion Criteria for SSc:
* Infected digital ulceration or necrosis with signs of infection.
* Severe pulmonary hypertension.
* History of systemic sclerosis renal crisis within 12 months prior to enrollment.
* History of active bleeding related to gastric antral vascular ectasia.
Exclusion Criteria for IIM:
* Other inflammatory and noninflammatory myopathies.
* Severe, irreversible muscle damage.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Key Inclusion Criteria:
Inclusion Criteria for systemic lupus erythematosus (SLE) and lupus nephritis (LN):
* Age ≥ 18 years
* Meet the European Alliance of Associations for Rheumatology (EULAR)- American College of Rheumatology (ACR) 2019 classification criteria for SLE
* Presence of autoantibodies as specified in the protocol
* Moderate to severe, active disease defined as at least one British Isles Lupus Assessment Group (BILAG-A) score or 2 BILAG B (excluding constitutional and/or neuropsychiatric organ system).
* Refractory to steroids and inadequate response or intolerance to at least 2 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolate mofetil or its derivatives, belimumab, anifrolumab, rituximab, obinutuzumab, methotrexate, azathioprine, cyclosporin, tacrolimus, or voclosporin.
* For LN: Refractory to steroids and inadequate response or intolerance to at least 2 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolate mofetil or its derivatives, belimumab, rituximab, obinutuzumab, azathioprine, cyclosporin, tacrolimus, or voclosporin
Inclusion Criteria for LN:
* Renal biopsy-proven Class III or intravenous (IV) ± V LN according to the revised International Society of Nephrology and Renal Pathology Society (ISN/RPS) criteria within 6 months prior to or during screening
* Evidence of active LN at screening
Inclusion Criteria for systemic sclerosis (SSc):
* Age ≥ 18 years
* Diffuse Systemic Sclerosis (SSc) according to ACR/EULAR 2013 classification criteria with active skin disease and/or progressive SSc-interstitial lung disease (ILD) OR limited SSc with progressive ILD.
* Refractory or intolerance to 1 of the following for a minimum of 3 months and/or contraindication: mycophenolate mofetil or its derivatives, methotrexate, tocilizumab (or other IL-6 inhibitor), rituximab (or other B-cell depleting agent), nintedanib (or other antifibrotic agents), cyclophosphamide.
* High-resolution computer tomography (HRCT) scan and pulmonary function test (PFT) within 3 months prior to screening.
Inclusion Criteria for idiopathic inflammatory myopathy (IIM):
* Age ≥ 18 years
* Probable or definite IIM based on EULAR/ACR 2017 classification (excluding inclusion body myositis).
* Active disease demonstrated by electromyography (EMG), magnetic resonance imaging (MRI) or muscle enzymes
* Moderate to severe disease activity
* Positive for myositis specific antibodies for patients with non-dermatomyostitis IIM
* HRCT scan and PFT within 3 months prior to screening.
* Refractory or intolerance to at least 1 month of glucocorticoids and standardized use of at least 2 immunosuppressant/modulator (eg, intravenous gamma globulins, methotrexate, mycophenolate mofetil and its derivatives, azathioprine, cyclophosphamide, calcineurin inhibitors, Janus kinase (JAK) inhibitors, rituximab or other B-cell depleting agent).
Inclusion Criteria for all Cohorts:
* Adequate hepatic, renal, pulmonary, and cardiac function.
Key Exclusion Criteria:
Exclusion Criteria for all Cohorts:
* Females of childbearing potential who are pregnant or breast feeding.
* Dialysis within the past year.
* History of malignancy, within the last 5 years.
* Hypogammaglobulinemia requiring immunoglobulin replacement.
* History of autologous or allogeneic stem cell transplant and/or organ transplant.
* Prior treatment with cellular therapy, gene therapy and/or T-cell engager therapy.
* Known history of HIV infection, or hepatitis B or C virus infections.
* Active or untreated latent tuberculosis (TB).
* Active or uncontrolled infections.
* Nonspecific, overlap, mixed autoimmune diseases not clearly identified into any of the studied cohorts.
Exclusion Criteria for LN:
* Significant pre-existing damage or rapidly progressive glomerulonephritis (GN).
Exclusion Criteria for SLE:
* Drug-induced SLE.
* Catastrophic antiphospholipid syndrome.
* Thrombotic thrombocytopenic purpura.
* Active or unstable lupus neuropsychiatric manifestations within last 6 months.
Exclusion Criteria for SSc:
* Infected digital ulceration or necrosis with signs of infection.
* Severe pulmonary hypertension.
* History of systemic sclerosis renal crisis within 12 months prior to enrollment.
* History of active bleeding related to gastric antral vascular ectasia.
Exclusion Criteria for IIM:
* Other inflammatory and noninflammatory myopathies.
* Severe, irreversible muscle damage.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Inclusion Criteria:
* Aged ≥ 18 years
* Willing and able to provide written informed consent, or with a legal representative who can provide informed consent (where locally approved)
* RSV confirmed by local lab testing via nucleic acid amplification test (e.g. polymerase chain reaction \[PCR\] or respiratory viral panel \[RVP\]) using an upper respiratory tract sample collected within the 5 days prior to day 1 (RDV dosing)
* Symptomatic RSV infection of the upper respiratory tract, with symptom onset and positive microbiologic testing within the 5 days prior to day 1 (RDV dosing). Symptomatic RSV infection is defined as having new upper respiratory symptom(s) or worsening of a pre-existing upper respiratory symptom (if chronic and associated with a previously existing diagnosis, such as chronic lung disease, chronic rhinorrhea, or seasonal allergies)
* Receiving treatment for a refractory or relapsed hematologic malignancy, or received a hematopoietic cell transplant (HCT), chimeric antigen receptor T cell therapy (CARTx), or bispecific antibody (bsAb) therapy within the past 365 days (relative to RSV diagnosis date)
* Categorized as moderate-risk (overall score 3-6) or high-risk (overall score 7-10) per an adapted version of the Immunodeficiency Scoring Index (ISI) for RSV, as below, relative to the day of RSV diagnosis:
* 1 point:
* Recent (within the prior 30 days) allogeneic HCT, autologous HCT, or CARTx
* Corticosteroids within the prior 30 days for management of graft versus host disease (GVHD) or cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS).
* 2 points:
* Age ≥ 40 years
* 3 points:
* Absolute neutrophil count (ANC) \< 500 cells/μL within the prior 7 days
* Absolute lymphocyte count (ALC) \< 200 cells/µL within the prior 7 days
* Oxygen saturation (SpO2) 93% or greater on room air and at rest (to be measured after participant has rested in a quiet room for ≥ 2 minutes, with oxygen \[O2\] saturation probe on finger or earlobe for ≥ 1 minute, with saturation reading remaining ≥ 93%) at screening
* Willingness to take study drug and complete necessary study procedures
* Participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described
Exclusion Criteria:
* Received or receiving an approved or authorized direct-acting antiviral therapy with potential efficacy against RSV (e.g. ribavirin) for ≥ 24 hours within the prior 7 days, and/or expected to receive anti-RSV direct-acting antiviral therapies for RSV during the course of the study at the time of screening
* Received or receiving investigational direct-acting antiviral therapies against RSV for the current RSV episode
* Received any investigational anti-RSV monoclonal antibodies or off-label use of approved anti-RSV monoclonal antibodies within \< 4 months or \< 5 half-lives, whichever is longer, before screening, or expected to receive anti-RSV monoclonal antibodies during the course of the study at the time of screening
* Received an RSV vaccine after cellular therapy or after starting the current antitumor therapeutic regimen
* Participation in any other concurrent clinical trial of an experimental treatment for RSV, including RSV vaccines
* Alanine aminotransferase (ALT) ≥ 5 times the upper limit of normal within 7 days prior to screening
* Unable to tolerate nasal sampling required for this study, as determined by the investigator (e.g., history of significant epistaxis, nasopharyngeal anatomical abnormalities, nasal or sinus surgery)
* A life expectancy of three months or less, as determined by the investigator
* Pregnant, as determined by a Point-of-Care urine pregnancy test or reported by the patient or their electronic health record within 7 days of screening
* Receiving, requiring, or expected to require supplemental oxygen for RSV-related illness or SpO2 \< 93% at rest \< 24 hours prior to study drug administration
* Previous infection or treatment for RSV, or previous treatment or hospitalization for another respiratory viral infection, \< 28 days before screening
* Documented positive test for other respiratory viruses concomitantly (limited to influenza, parainfluenza, adenovirus, human metapneumovirus, or coronavirus \[including SARS-CoV-2\]) ≤ 7 days prior to screening, as determined by local testing (additional testing not required)
* Clinically significant bacteremia or fungemia ≤ 7 days prior to screening and not adequately treated, as determined by the investigator
* Clinically significant bacterial, fungal, or viral pneumonia within two (2) weeks prior to screening and not adequately treated, as determined by the investigator
* Clinically significant symptoms of CRS or ICANS within the prior 72 hours before screening that is not adequately controlled, as determined by the investigator
* Any inability to take study drug or comply with study procedures that, in the opinion of the investigator, would make the participant unsuitable for the study
* Known hypersensitivity or allergy to the study drug, its metabolites, or formulation excipients
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Inclusion Criteria:
* Aged ≥ 18 years
* Willing and able to provide written informed consent, or with a legal representative who can provide informed consent (where locally approved)
* RSV confirmed by local lab testing via nucleic acid amplification test (e.g. polymerase chain reaction \[PCR\] or respiratory viral panel \[RVP\]) using an upper respiratory tract sample collected within the 5 days prior to day 1 (RDV dosing)
* Symptomatic RSV infection of the upper respiratory tract, with symptom onset and positive microbiologic testing within the 5 days prior to day 1 (RDV dosing). Symptomatic RSV infection is defined as having new upper respiratory symptom(s) or worsening of a pre-existing upper respiratory symptom (if chronic and associated with a previously existing diagnosis, such as chronic lung disease, chronic rhinorrhea, or seasonal allergies)
* Actively receiving treatment (within the past 90 days) for a refractory or relapsed hematologic malignancy, or received a hematopoietic cell transplant (HCT), chimeric antigen receptor T cell therapy (CARTx), or bispecific antibody (bsAb) therapy within the past 365 days (relative to RSV diagnosis date)
* Categorized as moderate-risk (overall score 3-6) or high-risk (overall score 7-10) per an adapted version of the Immunodeficiency Scoring Index (ISI) for RSV, as below, relative to the day of RSV diagnosis:
* 1 point:
* Recent (within the prior 30 days) allogeneic HCT, autologous HCT, or CARTx
* Corticosteroids within the prior 30 days for management of graft versus host disease (GVHD) or cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS).
* 2 points:
* Age ≥ 40 years
* 3 points:
* Absolute neutrophil count (ANC) \< 500 cells/μL within the prior 7 days
* Absolute lymphocyte count (ALC) \< 200 cells/µL within the prior 7 days
* Oxygen saturation (SpO2) 93% or greater on room air and at rest (to be measured after participant has rested in a quiet room for ≥ 2 minutes, with oxygen \[O2\] saturation probe on finger or earlobe for ≥ 1 minute, with saturation reading remaining ≥ 93%) at screening
* Willingness to take study drug and complete necessary study procedures
* Participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described
Exclusion Criteria:
* Received or receiving an approved or authorized direct-acting antiviral therapy with potential efficacy against RSV (e.g. ribavirin) for ≥ 24 hours within the prior 7 days, and/or expected to receive anti-RSV direct-acting antiviral therapies for RSV during the course of the study at the time of screening
* Received or receiving investigational direct-acting antiviral therapies against RSV for the current RSV episode
* Received any investigational anti-RSV monoclonal antibodies or off-label use of approved anti-RSV monoclonal antibodies within \< 4 months or \< 5 half-lives, whichever is longer, before screening, or expected to receive anti-RSV monoclonal antibodies during the course of the study at the time of screening
* Received an RSV vaccine after cellular therapy or after starting the current antitumor therapeutic regimen
* Participation in any other concurrent clinical trial of an experimental treatment for RSV, including RSV vaccines
* Alanine aminotransferase (ALT) ≥ 5 times the upper limit of normal within 7 days prior to screening
* Unable to tolerate nasal sampling required for this study, as determined by the investigator (e.g., history of significant epistaxis, nasopharyngeal anatomical abnormalities, nasal or sinus surgery)
* A life expectancy of three months or less, as determined by the investigator
* Pregnant, as determined by a Point-of-Care urine pregnancy test or reported by the patient or their electronic health record within 7 days of screening
* Receiving, requiring, or expected to require supplemental oxygen for RSV-related illness or SpO2 \< 93% at rest \< 24 hours prior to study drug administration
* Previous infection or treatment for RSV, or previous treatment or hospitalization for another respiratory viral infection, \< 28 days before screening
* Documented positive test for other respiratory viruses concomitantly (limited to influenza, parainfluenza, adenovirus, human metapneumovirus, or coronavirus \[including SARS-CoV-2\]) ≤ 7 days prior to screening, as determined by local testing (additional testing not required)
* Clinically significant bacteremia or fungemia ≤ 7 days prior to screening and not adequately treated, as determined by the investigator
* Clinically significant bacterial, fungal, or viral pneumonia within two (2) weeks prior to screening and not adequately treated, as determined by the investigator
* Clinically significant symptoms of CRS or ICANS within the prior 72 hours before screening that is not adequately controlled, as determined by the investigator
* Any inability to take study drug or comply with study procedures that, in the opinion of the investigator, would make the participant unsuitable for the study
* Known hypersensitivity or allergy to the study drug, its metabolites, or formulation excipients
Key Inclusion Criteria:
* Individuals must be glucagon-like peptide-1 receptor agonist (GLP-1RA) naïve OR last dose was at least 6 months prior to screening.
* Part A (SAD) and Part B (Food/PPI Effect): eligible individuals in Cohorts 1-4, (optional cohort 5) and 6 will include healthy individuals with BMI of ≥ 19 and \< 30 kg/m\^2, and no significant medical history.
Individuals will also be in good general health as determined by the investigator at the screening evaluation performed no more than 28 days prior to the scheduled first dose.
* Part C (MAD in nondiabetic obese individuals): Eligible individuals in Cohorts 7-9 and (optional cohort 10) will be individuals with obesity with BMI ≥ 30 kg/m\^2 and \< 45 kg/m\^2 with a total body weight \> 50 kg, and nondiabetic (HbA1c \< 6.5%). Eligible individuals will also be individuals with stable body weight (\< 5% change) for 90 days prior to screening visit based on individual report.
* Part D (multiple doses in non-obese T2DM): eligible individuals in Cohort 11 will be individuals with T2DM HbA1c ≥ 7.0% and ≤ 10.5% with BMI of ≥ 19 and \< 30 kg/m\^2 and treated with diet and/or exercise, and/or metformin monotherapy.
Key Exclusion Criteria:
* Have any serious or active medical or psychiatric illness (including depression) that, in the opinion of the investigator, would interfere with individual treatment, assessment, or compliance with the protocol. This would include acute pancreatitis, or history of pancreatitis, acute gallbladder disease, and renal, cardiac, hematological, hepatic, pulmonary (including chronic asthma), endocrine (including diabetes \[with the exception of T2DM for individuals included in Part D only\]), central nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy that are clinically significant or requiring treatment.
* Current symptoms of diabetic retinopathy or examination indicating diabetic retinopathy within one year of screening.
* Any electrolyte disturbances identified at screening considered to be clinically significant in the opinion of the investigator (eg, hypokalemia, hypocalcemia, or hypomagnesemia).
* Any condition that could lead to electrolyte disturbances (eg, eating disorder) in the opinion of the investigator.
* History of syncope, palpitations, or unexplained dizziness.
* Active, or history of, significant cardiac disease or conduction abnormality
* History of implanted defibrillator or pacemaker.
* Have been treated with the following within 6 months prior to screening or is expected to receive these agents during the study: GLP-1RAs, systemic steroids, immunosuppressant therapies, or chemotherapeutic agents (eg, corticosteroids, immunoglobulins, other immune or cytokine-based therapies).
* Previously stopped use of GLP-1RAs secondary to severe side effects including nausea, constipation, diarrhea, or emesis.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Key Inclusion Criteria:
* Age 18 through 55 years, for Parts A, B, and C, and 18 through 65 years, for Part D.
* Individuals must be glucagon-like peptide-1 receptor agonist (GLP-1RA) naïve OR last dose was at least 6 months prior to screening.
* Part A (SAD) and Part B (Food/PPI Effect): eligible individuals in Cohorts 1-4, (optional cohort 5) and 6 will include healthy individuals with BMI of ≥ 19 and \< 30 kg/m\^2, and no significant medical history.
Individuals will also be in good general health as determined by the investigator at the screening evaluation performed no more than 28 days prior to the scheduled first dose.
* Part C (MAD in nondiabetic obese individuals): Eligible individuals in Cohorts 7-9 and (optional cohort 10) will be individuals with obesity with BMI ≥ 30 kg/m\^2 and \< 45 kg/m\^2 with a total body weight \> 50 kg, and nondiabetic (HbA1c \< 6.5%). Eligible individuals will also be individuals with stable body weight (\< 5% change) for 90 days prior to screening visit based on individual report.
* Part D (multiple doses in non-obese T2DM): eligible individuals in Cohort 11 will be individuals with T2DM HbA1c ≥ 7.0% and ≤ 10.5% with BMI of ≥ 19 and \< 30 kg/m\^2 and treated with diet and/or exercise, and/or metformin monotherapy.
Key Exclusion Criteria:
* Have any serious or active medical or psychiatric illness (including depression) that, in the opinion of the investigator, would interfere with individual treatment, assessment, or compliance with the protocol. This would include acute pancreatitis, or history of pancreatitis, acute gallbladder disease, and renal, cardiac, hematological, hepatic, pulmonary (including chronic asthma), endocrine (including diabetes \[with the exception of T2DM for individuals included in Part D only\]), central nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy that are clinically significant or requiring treatment.
* Current symptoms of diabetic retinopathy or examination indicating diabetic retinopathy within one year of screening.
* Any electrolyte disturbances identified at screening considered to be clinically significant in the opinion of the investigator (eg, hypokalemia, hypocalcemia, or hypomagnesemia).
* Any condition that could lead to electrolyte disturbances (eg, eating disorder) in the opinion of the investigator.
* History of syncope, palpitations, or unexplained dizziness.
* Active, or history of, significant cardiac disease or conduction abnormality
* History of implanted defibrillator or pacemaker.
* Have been treated with the following within 6 months prior to screening or is expected to receive these agents during the study: GLP-1RAs, systemic steroids, immunosuppressant therapies, or chemotherapeutic agents (eg, corticosteroids, immunoglobulins, other immune or cytokine-based therapies).
* Previously stopped use of GLP-1RAs secondary to severe side effects including nausea, constipation, diarrhea, or emesis.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Inclusion Criteria:
* Reproductive status-related eligibility and contraception requirements:
* Participants must agree to use protocol-specified method(s) of contraception where applicable
Inclusion Criteria for multiple sclerosis (MS):
MS (Relapsing and progressive forms):
* Diagnosed with MS according to the 2017 revision of the McDonald diagnostic criteria
Relapsing forms of MS (relapsing-remitting multiple sclerosis (RRMS), active secondary-progressive multiple sclerosis (aSPMS)):
* Inadequate response to previous therapies is defined as evidence of breakthrough disease activity within 12 months prior to screening while on high efficacy disease-modifying therapy (DMT) OR Inadequate response to previous therapies defined as intolerance to ≥ 2 DMTs due to side effects prohibiting the chronic use of the DMT.
* Expanded Disability Status Scale (EDSS) 0 to 5.5
Progressive forms of MS (primary-progressive multiple sclerosis (PPMS) and non-active secondary-progressive multiple sclerosis (naSPMS)):
* Inadequate response to previous therapies is defined as evidence of disease progression within 12 months prior to screening despite standard of care therapy for naSPMS or despite ocrelizumab, where available, for PPMS
* Absence of clinical relapses for at least 24 months
* No evidence of Gadolinium enhancing (GadE+) on magnetic resonance imaging (MRI) brain at screening or baseline
* EDSS of 3 to 6.5 who are ambulatory
Inclusion Criteria for myasthenia gravis (MG):
* Documentation of autoantibodies against acetylcholine receptor (AChR), muscle-specific kinase (MuSK), or low-density lipoprotein receptor-related protein 4 (LRP4)
* Diagnosis of MG with generalized weakness meeting criteria as defined by the Myasthenia Gravis Foundation of American (MGFA) classification of II- IV at screening
* Myasthenia Gravis Activities of Daily Living (MG-ADL) score ≥ 6 (\> 50% of the total score due to non-ocular symptoms)
* Quantitative Myasthenia Gravis (QMG) score ≥ 10
* Inadequate response to previous therapies while taking at least 2 classes of immunosuppressants (ie, steroids, azathioprine (AZA), mycophenolate mofetil (MMF), intravenous immunoglobulin (IVIg), biologics (eg, rituximab, anti-neonatal fragment crystallizable (Fc) receptor (FcRN) class, and anti-complement class))
* Thymectomy allowed if completed ≥ 12 months prior to screening
Inclusion Criteria for chronic inflammatory demyelinating polyneuropathy (CIDP):
* Probable or definite CIDP as defined by the 2010 European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) criteria, relapsing or progressive forms
* CIDP Disease Activity Status (CDAS) score ≥ 3 at screening
* Inflammatory neuropathy cause and treatment (INCAT) score ≥ 3
* Inadequate response to previous therapies despite standard of care therapy (ie, steroids, IVIg, subcutaneous immunoglobulin (SCIg), plasmapheresis exchange (PLEX), rituximab, or anti FcRN) OR Unable to tolerate standard of care due to side effects with ongoing disease activity
* Except for nodal/paranodal CIDP, historical documentation of objective improvement in the past 24 months while on IVIg, SCIg, PLEX, or anti-FcRN OR Historical documentation of objective disease worsening in the past 24 months when IVIg, SCIg, PLEX, or anti-FcRN has been reduced or interrupted
Key Exclusion Criteria:
* History or presence of central nervous system (CNS) or peripheral nervous system disorders before enrollment that may impact cognition, strength, or cause weakness
* History of autologous or allogeneic stem cell transplant and/or organ transplant
Exclusion Criteria for MS:
* Cohort 1 or 2; inability to complete 9-hole Peg Test (9-HPT) in \< 240 seconds and Timed 25 foot Walk (T25FW) \< 150 seconds
* History of hypersensitivity to parenteral administration of gadolinium-based contrast agents
* Any renal condition that would preclude the administration of gadolinium (for the relapsing forms of MS and progressive forms of MS)
* Any contraindication to lumbar puncture (LP) (for the relapsing forms of MS and progressive forms of MS)
Exclusion Criteria for MG:
* Current myasthenic crisis not effectively controlled within 2 weeks before enrollment
* Thymectomy performed within 12 months of baseline
Exclusion Criteria for CIDP:
* Pure sensory CIDP and focal CIDP
* Polyneuropathy of other causes
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Key Inclusion Criteria:
* Age 18 through 65 for relapsing forms of MS, 18 through 75 for progressive forms of MS, above 18 years of age for MG and CIDP.
* Reproductive status-related eligibility and contraception requirements:
* Individuals must agree to use protocol-specified method(s) of contraception where applicable
Inclusion Criteria for multiple sclerosis (MS):
MS (Relapsing and progressive forms):
* Diagnosed with MS according to the 2017 revision of the McDonald diagnostic criteria
Relapsing forms of MS (relapsing-remitting multiple sclerosis (RRMS), active secondary-progressive multiple sclerosis (aSPMS)):
* Inadequate response to previous therapies is defined as evidence of breakthrough disease activity within 12 months prior to screening while on high efficacy disease-modifying therapy (DMT) OR Inadequate response to previous therapies defined as intolerance to ≥ 2 DMTs due to side effects prohibiting the chronic use of the DMT.
* Expanded Disability Status Scale (EDSS) 0 to 6.0
Progressive forms of MS (primary-progressive multiple sclerosis (PPMS) and non-active secondary-progressive multiple sclerosis (naSPMS)):
* Inadequate response to previous therapies is defined as evidence of disease progression within 12 months prior to screening despite standard of care therapy for naSPMS or despite ocrelizumab, where available, for PPMS
* Absence of clinical relapses for at least 24 months
* No evidence of Gadolinium enhancing (GadE+) on magnetic resonance imaging (MRI) brain at screening or baseline
* EDSS of 3 to 6.5 who are ambulatory
Inclusion Criteria for myasthenia gravis (MG):
* Documentation of autoantibodies against acetylcholine receptor (AChR), muscle-specific kinase (MuSK), or low-density lipoprotein receptor-related protein 4 (LRP4)
* Diagnosis of MG with generalized weakness meeting criteria as defined by the Myasthenia Gravis Foundation of American (MGFA) classification of II- IV at screening
* Myasthenia Gravis Activities of Daily Living (MG-ADL) score ≥ 6 (\> 50% of the total score due to non-ocular symptoms)
* Quantitative Myasthenia Gravis (QMG) score ≥ 10
* Inadequate response to previous therapies while taking at least 2 classes of immunosuppressants (ie, steroids, azathioprine (AZA), mycophenolate mofetil (MMF), intravenous immunoglobulin (IVIg), biologics (eg, rituximab, anti-FcRN class, and anti-complement class))
* Thymectomy allowed if completed ≥ 12 months prior to screening
Inclusion Criteria for chronic inflammatory demyelinating polyneuropathy (CIDP):
* Probable or definite CIDP as defined by the 2010 European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) criteria, relapsing or progressive forms. Individuals with confirmed IgG4 paranodal antibodies (eg, NF155, CNTN1, Caspr1) are eligible if they meet EFNS/PNS 2010 criteria
* For the Phase 1b CIDP cohort, diagnosis will be confirmed by independent adjudication once the adjudication committee is established and operational
* CIDP Disease Activity Status (CDAS) score ≥ 3 at screening and confirmed at the final pre treatment assessment prior to infusion
* Inflammatory neuropathy cause and treatment (INCAT) score ≥ 3 at screening and confirmed at one of more protocol-defined baseline assessments during the Extended Screening Period with Observational Run-in; individuals must also continue to meet clinical eligibility criteria at the final pre-treatment assessment prior to infusion
* Inadequate response to previous therapies despite adequate trial of standard of care therapy (≥ 8-12 weeks at standard dosing with stable regimen of either steroids, IVIg, SCIg, plasmapheresis exchange (PLEX), rituximab or anti-FcRN) and either failure, intolerance, or contraindication to at least one additional standard therapy (ie, steroids, IVIg, subcutaneous immunoglobulin (SCIg), plasmapheresis exchange (PLEX), rituximab, or anti FcRN), unless medically inappropriate OR Unable to tolerate standard of care resulting in discontinuation due to side effects, with ongoing disease activity
* Except for nodal/paranodal CIDP, historical documentation of objective improvement in the past 24 months while on IVIg, SCIg, PLEX, or anti-FcRN OR Historical documentation of objective disease worsening in the past 24 months when IVIg, SCIg, PLEX, or anti-FcRN has been reduced or interrupted
Key Exclusion Criteria:
* History or presence of central nervous system (CNS) or peripheral nervous system disorders before enrollment that may impact cognition, strength, or cause weakness
* History of autologous or allogeneic stem cell transplant and/or organ transplant
* History of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
Exclusion Criteria for MS:
* Cohort 1 or 2; inability to complete 9-hole Peg Test (9-HPT) in \< 240 seconds and Timed 25 foot Walk (T25FW) \< 150 seconds
* History of hypersensitivity to parenteral administration of gadolinium-based contrast agents
* Any renal condition that would preclude the administration of gadolinium (for the relapsing forms of MS and progressive forms of MS)
* Any contraindication to lumbar puncture (LP) (for the relapsing forms of MS and progressive forms of MS)
Exclusion Criteria for MG:
* Current myasthenic crisis not effectively controlled within 2 weeks before enrollment
* Thymectomy performed within 12 months of baseline
Exclusion Criteria for CIDP:
* Pure sensory CIDP and focal CIDP
* Polyneuropathy of other causes
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Inclusion Criteria:
Medical History/Physical Characteristics
* Histologically or cytologically confirmed unresectable, recurrent, or locally advanced or metastatic microsatellite stable colorectal cancer (MSS CRC) (adenocarcinoma, excluding appendix cancer).
* Documented MSS or proficient mismatch repair (pMMR) disease by local assessment using a validated polymerase chain reaction (PCR) (microsatellite status) and/or immunohistochemistry (IHC) mismatch repair (MMR) assay is required.
* Has received up to 2 prior lines of systemic therapy for advanced or metastatic CRC, which must have included at least fluoropyrimidine-, oxaliplatin-, irinotecan-based chemotherapies if indicated; and if applicable: anti-vascular endothelial growth factor (VEGF) therapy, anti epidermal growth factor receptor (EGFR) therapy, encorafenib or adagrasib/sotorasib.
* Documented progressive disease (PD) by computed tomography (CT) or magnetic resonance imaging (MRI) during or after the most recent therapy per RECIST Version 1.1 criteria by investigator assessment.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
Laboratory Assessments
* Have adequate organ function.
Key Exclusion Criteria with:
Medical Conditions/History:
* Significant cardiovascular disease.
* History of autoimmune disease or active autoimmune disease that has required systemic treatment within 2 years.
* History of (noninfectious) pneumonitis/interstitial lung disease or current pneumonitis/ interstitial lung disease.
* History of gastrointestinal (GI) perforation, permanent ileostomy, abdominal abscess or fistula within 6 months, active or uncontrolled GI bleeding within 4 weeks, or any condition associated with significant risk of bleeding or perforation (eg, untreated varices, tumor erosion, recent GI surgery).
Prior/Concurrent Therapy or Clinical Study Experience
Prior treatment with:
* Trifluridine-tipiracil, regorafenib, or fruquitinib.
* Any immuno-oncology therapy.
* Anticancer biologic agent within 4 weeks prior to randomization or have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to randomization and have not recovered (ie, Grade 2 or less) from AEs from prior anticancer therapy at the time of randomization. Individuals in observational studies are eligible.
* Allogeneic tissue/solid organ transplantation, including allogeneic stem cell transplantation. Exception: prior corneal transplant without requirement for systemic immunosuppressive agents is allowed.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Key Inclusion Criteria:
Medical History/Physical Characteristics
* Histologically or cytologically confirmed unresectable, recurrent, or locally advanced or metastatic microsatellite stable colorectal cancer (MSS CRC) (adenocarcinoma, excluding appendix cancer).
* Documented MSS or proficient mismatch repair (pMMR) disease by local assessment using a validated polymerase chain reaction (PCR) (microsatellite status) and/or immunohistochemistry (IHC) mismatch repair (MMR) assay is required.
* Has received up to 2 prior lines of systemic therapy for advanced or metastatic CRC, which must have included at least fluoropyrimidine-, oxaliplatin-, irinotecan-based chemotherapies if indicated; and if applicable: anti-vascular endothelial growth factor (VEGF) therapy, anti epidermal growth factor receptor (EGFR) therapy, encorafenib or adagrasib/sotorasib.
* Documented progressive disease (PD) by computed tomography (CT) or magnetic resonance imaging (MRI) during or after the most recent therapy per RECIST Version 1.1 criteria by investigator assessment.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
Laboratory Assessments
* Have adequate organ function.
Key Exclusion Criteria with:
Medical Conditions/History:
* Significant cardiovascular disease.
* History of autoimmune disease or active autoimmune disease that has required systemic treatment within 2 years.
* History of (noninfectious) pneumonitis/interstitial lung disease or current pneumonitis/ interstitial lung disease.
* History of gastrointestinal (GI) perforation, permanent ileostomy, abdominal abscess or fistula within 6 months, active or uncontrolled GI bleeding within 4 weeks, or any condition associated with significant risk of bleeding or perforation (eg, untreated varices, tumor erosion, recent GI surgery).
Prior/Concurrent Therapy or Clinical Study Experience
Prior treatment with:
* Trifluridine-tipiracil, regorafenib, or fruquitinib.
* Any immuno-oncology therapy.
* Anticancer biologic agent within 4 weeks prior to randomization or have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to randomization and have not recovered (ie, Grade 2 or higher is considered not recovered) from AEs from prior anticancer therapy at the time of randomization. Individuals in observational studies are eligible.
* Allogeneic tissue/solid organ transplantation, including allogeneic stem cell transplantation. Exception: prior corneal transplant without requirement for systemic immunosuppressive agents is allowed.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Inclusion Criteria:
* Have a diagnosis of PBC as defined by a history of any 2 of the following criteria:
1. ALP above 1.0 × the ULN for at least 6 months
2. Positive antimitochondrial antibody titer (\> 1:40 on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay) or positive PBC-specific antinuclear antibodies
3. Documented liver biopsy results consistent with PBC
* Used ursodeoxycholic acid (UDCA) for the past 12 months (stable dose for \> 6 months prior to screening), or intolerant to UDCA (last dose of UDCA \> 90 days prior to screening)
* Have an ALP ≥ 1.67 × ULN at screening
* Have a negative serum pregnancy test at screening
Key Exclusion Criteria:
* Have other causes of liver disease including viral, alcoholic, autoimmune, and metabolic associated steatohepatitis (MASH).
* Cirrhosis with Child-Pugh Score ≥ 7, corresponding to Class B or C. Individuals with compensated cirrhosis (ie, Child-Pugh Class A) are allowed if they meet all other criteria.
* Have evidence of portal hypertension or clinically important hepatic decompensation (historic or current), including but not limited to: hepatic encephalopathy, known esophageal or gastric varices, history of liver transplantation, current placement on liver transplant list, Model for End Stage Liver Disease score ≥ 12, ascites, spontaneous bacterial peritonitis, hepatorenal syndrome.
* Have previous exposure to seladelpar or cilofexor
* Used obeticholic acid, fenofibrate, bezafibrate, elafibranor, pemafibrate, or saroglitazar within 6 weeks (42 days, inclusive) of screening date
* Require or expect to require treatment with ≥ 5 mg prednisone (or systemic equivalents) for \> 2 weeks during the Blinded Treatment or ATE Periods
* Are on any systemic drug for antipruritic treatment that has required a dose adjustment in the 30 days before screening, or initiated a systemic antipruritic drug in the 30 days before screening
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Key Inclusion Criteria:
* Have a diagnosis of primary biliary cholangitis (PBC) as defined by a history of any 2 of the following criteria:
1. ALP above 1.0 × the ULN for at least 6 months
2. Positive antimitochondrial antibody titer (\> 1:40 on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay) or positive PBC-specific antinuclear antibodies
3. Documented liver biopsy results consistent with PBC
* Used ursodeoxycholic acid (UDCA) for the past 12 months (stable dose for \> 6 months prior to screening), or intolerant to UDCA (last dose of UDCA \> 90 days prior to screening)
* Have an ALP ≥ 1.67 × ULN at screening
* Have a negative serum pregnancy test at screening
Key Exclusion Criteria:
* Have other causes of liver disease including viral, alcoholic, autoimmune, and metabolic associated steatohepatitis (MASH).
* Cirrhosis with Child-Pugh Score ≥ 7, corresponding to Class B or C. Individuals with compensated cirrhosis (ie, Child-Pugh Class A) are allowed if they meet all other criteria.
* Have evidence of portal hypertension or clinically important hepatic decompensation (historic or current), including but not limited to: hepatic encephalopathy, known esophageal or gastric varices, history of liver transplantation, current placement on liver transplant list, Model for End Stage Liver Disease score ≥ 12, ascites, spontaneous bacterial peritonitis, hepatorenal syndrome.
* Have previous exposure to seladelpar or cilofexor
* Used obeticholic acid, fenofibrate, bezafibrate, elafibranor, pemafibrate, or saroglitazar within 6 weeks (42 days, inclusive) of screening date
* Require or expect to require treatment with ≥ 5 mg prednisone (or systemic equivalents) for \> 2 weeks during the study
* Are on any systemic drug for antipruritic treatment that has required a dose adjustment in the 30 days before screening, or initiated a systemic antipruritic drug in the 30 days before screening
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Inclusion Criteria: for Phase 1a/b and Phase 2
* Relapsed and/or refractory B-cell lymphoma (R/R BCL).
* At least 1 measurable lesion.
* Adequate organ and bone marrow (BM) function.
Key Exclusion Criteria: for Phase 1a/b and Phase 2
\- History of chimeric antigen receptor (CAR) therapy or other genetically modified T cell therapy.
* History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, or breast) unless disease free and without anticancer therapy (with the exception of hormonal therapy in the case of breast cancer) for at least 3 years.
* History of allogeneic stem cell transplant (allo-SCT).
* Auto-SCT within 6 weeks before the planned KITE-363 or KITE-753 infusion.
* Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requires intravenous (IV) antimicrobials for management.
* Known history of human immunodeficiency virus (HIV) infection, hepatitis B virus (HBV) (hepatitis B surface \[HBs\] antigen \[HBsAg\] positive) infection, or hepatitis C (anti-hepatitis C virus \[HCV\] positive) infection. History of a hepatitis B or C infection is permitted if the viral load is undetectable per quantitative polymerase chain reaction (qPCR) or nucleic acid testing.
* Individuals with suspicion and/or evidence of primary or secondary CNS lymphoma.
* History or presence of a CNS disorder.
* History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, active arrhythmia, New York Heart Association Class II or greater congestive heart failure or other clinically significant cardiac disease within the 6 months before enrollment.
* Primary immunodeficiency.
* History of autoimmune disease resulting in or requiring systemic immunosuppression and/or systemic disease-modifying agents within the last 90 days.
* Individuals with full thickness lymphoma involvement of the gastric or intestinal lining and/or transmural gastrointestinal (GI) tract involvement, or with concern for gastric or intestinal perforation or known contained gastric or intestinal perforation.
* Females of childbearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Females who have undergone surgical sterilization or have been postmenopausal for at least 2 years are not considered to be of childbearing potential.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Key Inclusion Criteria: for Phase 1a/b and Phase 2
* Relapsed and/or refractory B-cell lymphoma (R/R BCL).
* At least 1 measurable lesion.
* Adequate organ and bone marrow (BM) function.
Key Exclusion Criteria: for Phase 1a/b and Phase 2
* History of chimeric antigen receptor (CAR) therapy or other genetically modified T cell therapy.
* Phase 1b Cohort D only: Absolute lymphocyte count ≥ 20,000/μL.
* History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, or breast) unless disease free and without anticancer therapy (with the exception of hormonal therapy in the case of breast cancer) for at least 3 years.
* History of allogeneic stem cell transplant (allo-SCT).
* Auto-SCT within 6 weeks before the planned KITE-363 or KITE-753 infusion.
* Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requires intravenous (IV) antimicrobials for management.
* Known history of human immunodeficiency virus (HIV) infection, hepatitis B virus (HBV) (hepatitis B surface \[HBs\] antigen \[HBsAg\] positive) infection, or hepatitis C (anti-hepatitis C virus \[HCV\] positive) infection. History of a hepatitis B or C infection is permitted if the viral load is undetectable per quantitative polymerase chain reaction (qPCR) or nucleic acid testing.
* Individuals with suspicion and/or evidence of primary or secondary CNS lymphoma.
* History or presence of a CNS disorder.
* History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, active arrhythmia, New York Heart Association Class II or greater congestive heart failure or other clinically significant cardiac disease within the 6 months before enrollment.
* Primary immunodeficiency.
* History of autoimmune disease resulting in or requiring systemic immunosuppression and/or systemic disease-modifying agents within the last 90 days.
* Individuals with concern for gastric or intestinal perforation or known contained perforation.
* Females of childbearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Females who have undergone surgical sterilization or have been postmenopausal for at least 2 years are not considered to be of childbearing potential.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.