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A Study of KITE-363 in Participants With Refractory Autoimmune Diseases

A Phase 1 Open-label, Multiregional, Multicenter, Basket Study Evaluating the Safety and Efficacy of KITE-363, an Autologous Anti-CD19/CD20 CAR T-cell Therapy in Participants With Refractory Autoimmune Diseases

Status
Enrolling by invitation
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07038447
Enrollment
52
Registered
2025-06-26
Start date
2025-07-02
Completion date
2029-07-01
Last updated
2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Inflammatory Myopathy, Lupus Nephritis, Systemic Lupus Erythematosus, Systemic Sclerosis

Brief summary

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.

Interventions

BIOLOGICALKITE-363

A single infusion of CAR-transduced autologous T cells administered intravenously

DRUGFludarabine

Administered intravenously

DRUGCyclophosphamide

Administered intravenously

Sponsors

Kite, A Gilead Company
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Phase 1a: Percentage of Participants Experiencing Adverse Events Defined as Dose-limiting Toxicities (DLTs) After the Infusion of KITE-363Up 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 6Month 6
Phase 1b: Lupus Nephritis (LN): Proportion of Participants Meeting DORIS RemissionMonth 6
Phase 1b: LN: Proportion of Participants Achieving a Complete Renal Response at Month 6Month 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 6Month 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 6Month 6

Secondary

MeasureTime frameDescription
Characterization of Product, Including T-cell Phenotype as Assessed by Percent Change From Baseline in cluster of differentiation 3 (CD3)+ Cells and T CellsBaseline up to 2 years
Pharmacokinetic parameter: Serum Concentration of KITE-363 CAR T-cellsUp to 2 years
Pharmacokinetic parameter: Peak Concentration (Cmax) for KITE-363 CAR T-cellsUp to 2 years
Pharmacokinetic parameter: AUC for KITE-363 CAR T-cellsUp to 2 yearsAUC is defined as the area under the concentration time curve for KITE-363 CAR T-cells.
Pharmacokinetic parameter: Time to Peak Serum Concentration (Tmax) for KITE-363 CAR T-cellsUp 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 timeUp 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 factorsUp to 2 years
Pharmacodynamic Parameters: AUC for Pro-inflammatory and Immune-modulating Cytokines, Chemokines, and Effector molecules, Autoantibodies, Muscle Enzymes, and Complement factorsUp to 2 yearsAUC is defined as the area under the concentration time curve.
Pharmacodynamic Parameters: Time to Peak Serum Concentration (Tmax) for Pro-inflammatory and Immune-modulating Cytokines, Chemokines, and Effector molecules, Autoantibodies, Muscle Enzymes, and Complement factorsUp to 2 years
Percentage of Participants with Antibodies Against KITE-363 CAR T cellsUp to 2 years
Change from Baseline in Levels of B cellsUp to 2 years

Countries

Australia, Canada, United States

Contacts

STUDY_DIRECTORKite Study Director

Kite, A Gilead Company

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026