This study will have two Phases: Phase 1a and Phase 1b. The goal of this clinical study is to learn more about the study drug KITE-363, to establish dosing, tolerability, safety, and preliminary efficacy of KITE-363 in participants with refractory autoimmune diseases. The primary objectives of this study are: Phase 1a: To evaluate the safety and tolerability of KITE-363 in participants with autoimmune disease. To determine the recommended dose for Phase 1b. Phase 1b: To evaluate the safety and efficacy of KITE-363 in participants with autoimmune disease.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
A single infusion of CAR-transduced autologous T cells administered intravenously
Administered intravenously
Administered intravenously
City of Hope
Duarte, California, United States
Stanford University
Stanford, California, United States
Concord Repatriation General Hospital
Syndey, New South Wales, Australia
St Vincent's Hospital
Fitzroy, Victoria, Australia
Jewish General Hospital
Montreal, Canada
Phase 1a: Percentage of Participants Experiencing Adverse Events Defined as Dose-limiting Toxicities (DLTs) After the Infusion of KITE-363
Time frame: Up to 2 years
Phase 1b: All Cohorts Percentage of Participants Experiencing Treatment-emergent Adverse Event (TEAEs)
Time frame: Up to 2 years
Phase 1b: Systemic lupus erythematosus (SLE)/ Lupus Nephritis (LN): Proportion of Participants Meeting DORIS Remission and Lupus low Disease Activity State (LLDAS) Criteria at Month 6
Time frame: Month 6
Phase 1b: Lupus Nephritis (LN): Proportion of Participants Achieving a Complete Renal Response
Time frame: Month 6
Phase 1b: Systemic Sclerosis (SSc) Cohort: Proportion of Participants with Improvement in Disease Activity by the Revised Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (rCRISS) at Month 6
Time frame: Month 6
Phase 1b: Systemic Sclerosis (SSc) Cohort: Proportion of Participants With Progressive Interstitial Lung Disease (ILD), no Worsening of Pulmonary Function at Month 6
Time frame: Month 6
Phase 1b: Idiopathic Inflammatory Myopathy: Proportions of Participants Meeting European League Against Rheumatism (EULAR)-American College of Rheumatology (ACR) Moderate and Major response 2016 Criteria in Total Improvement Score (TIS) at Month 6
Time frame: Month 6
Characterization of Product, Including T-cell Phenotype as Assessed by Percent Change From Baseline in cluster of differentiation 3 (CD3)+ Cells and T Cells
Time frame: Baseline up to 2 years
Pharmacokinetic parameter: Serum Concentration of KITE-363 CAR T-cells
Time frame: Up to 2 years
Pharmacokinetic parameter: Peak Concentration (Cmax) for KITE-363 CAR T-cells
Time frame: Up to 2 years
Pharmacokinetic parameter: AUC for KITE-363 CAR T-cells
AUC is defined as the area under the concentration time curve for KITE-363 CAR T-cells.
Time frame: Up to 2 years
Pharmacokinetic parameter: Time to Peak Serum Concentration (Tmax) for KITE-363 CAR T-cells
Time frame: Up to 2 years
Pharmacodynamic Parameters: Serum Concentration of Pro-inflammatory and Immune-modulating Cytokines, Chemokines, and Effector molecules, Autoantibodies, Muscle Enzymes, and Complement factors in blood over time
Time frame: Up to 2 years
Pharmacodynamic Parameters: Peak Serum Concentration (Cmax) for Pro-inflammatory and Immune-modulating Cytokines, Chemokines, and Effector molecules, Autoantibodies, Muscle Enzymes, and Complement factors
Time frame: Up to 2 years
Pharmacodynamic Parameters: AUC for Pro-inflammatory and Immune-modulating Cytokines, Chemokines, and Effector molecules, Autoantibodies, Muscle Enzymes, and Complement factors
AUC is defined as the area under the concentration time curve.
Time frame: Up to 2 years
Pharmacodynamic Parameters: Time to Peak Serum Concentration (Tmax) for Pro-inflammatory and Immune-modulating Cytokines, Chemokines, and Effector molecules, Autoantibodies, Muscle Enzymes, and Complement factors
Time frame: Up to 2 years
Percentage of Participants with Antibodies Against KITE-363 CAR T cells
Time frame: Up to 2 years
Change from Baseline in Levels of B cells
Time frame: Up to 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.