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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1a: KITE-363 (Dose Escalation) | Experimental | Participants with refractory autoimmune diseases will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by 2 dose escalations of KITE-363 chimeric antigen receptor (CAR) transduced autologous T cells to find the Phase 1b recommended dose. |
|
| Phase 1b: KITE-363 (Dose Expansion) | Experimental | Participants with refractory autoimmune diseases will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed Phase 1ab recommended dose of KITE-363 CAR T cells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KITE-363 | Biological | A single infusion of CAR-transduced autologous T cells administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1a: Percentage of Participants Experiencing Adverse Events Defined as Dose-limiting Toxicities (DLTs) After the Infusion of KITE-363 | Up to 2 years | |
| Phase 1b: All Cohorts Percentage of Participants Experiencing Treatment-emergent Adverse Event (TEAEs) | Up to 2 years | |
| Phase 1b: Systemic lupus erythematosus (SLE): Proportion of participants meeting DORIS remission and Lupus low Disease Activity State (LLDAS) criteria at Month 6 | Month 6 | |
| Phase 1b: Lupus Nephritis (LN): Proportion of Participants Meeting DORIS Remission | Month 6 | |
| Phase 1b: LN: Proportion of Participants Achieving a Complete Renal Response at Month 6 | 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 | Month 6 | |
| Phase 1b: Idiopathic Inflammatory Myopathy (IIM): 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 | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Characterization of Product, Including T-cell Phenotype as Assessed by Percent Change From Baseline in cluster of differentiation 3 (CD3)+ Cells and T Cells | Baseline up to 2 years | |
| Pharmacokinetic parameter: Serum Concentration of KITE-363 CAR T-cells |
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Key Inclusion Criteria:
Inclusion Criteria for systemic lupus erythematosus (SLE) and lupus nephritis (LN):
Inclusion Criteria for LN:
Inclusion Criteria for systemic sclerosis (SSc):
Inclusion Criteria for idiopathic inflammatory myopathy (IIM):
Inclusion Criteria for all Cohorts:
Key Exclusion Criteria:
Exclusion Criteria for all Cohorts:
Exclusion Criteria for LN:
Exclusion Criteria for SLE:
Exclusion Criteria for SSc:
Exclusion Criteria for IIM:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Kite Study Director | Kite, A Gilead Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| Stanford University |
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| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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| Fludarabine | Drug | Administered intravenously |
|
| Cyclophosphamide | Drug | Administered intravenously |
|
| Up to 2 years |
| Pharmacokinetic parameter: Peak Concentration (Cmax) for KITE-363 CAR T-cells | 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. | Up to 2 years |
| Pharmacokinetic parameter: Time to Peak Serum Concentration (Tmax) for KITE-363 CAR T-cells | 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 | 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 | 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. | 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 | Up to 2 years |
| Percentage of Participants with Antibodies Against KITE-363 CAR T cells | Up to 2 years |
| Change from Baseline in Levels of B cells | Up to 2 years |
| Stanford |
| California |
| 94305 |
| United States |
| Tampa General Hospital Cancer Institute | Tampa | Florida | 33606 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Concord Repatriation General Hospital | Syndey | New South Wales | 2139 | Australia |
| St Vincent's Hospital | Fitzroy | Victoria | 3065 | Australia |
| Jewish General Hospital | Montreal | H3T1E2 | Canada |
| The Ottawa Hospital, General Campus | Ottawa | K1H 8L6 | Canada |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D008181 | Lupus Nephritis |
| D012595 | Scleroderma, Systemic |
| D009220 | Myositis |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012871 | Skin Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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