Abstract: INFO14-FR
Phase 1 Open-Label Basket Study of KITE-363 Anti-CD19/CD20 Chimeric Antigen Receptor (CAR) T-Cell Therapy in Patients with Refractory Autoimmune Diseases
Session Information
- Informational Posters - 2
November 07, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- No subcategory defined
Authors
- Filosto, Simone, Kite, a Gilead Company, Santa Monica, California, United States
- Chung, Lorinda, Stanford University, Stanford, California, United States
- Fiorentino, David, Stanford University, Stanford, California, United States
- Falconer, Janlyn, Concord Repatriation General Hospital, Concord, New South Wales, Australia
- Riminton, Dominic Sean, Concord Repatriation General Hospital, Concord, New South Wales, Australia
- Bradhurst, Peter, Concord Repatriation General Hospital, Concord, New South Wales, Australia
- Mian, Aneela Naseem, Kite, a Gilead Company, Santa Monica, California, United States
- Tang, Emma, Kite, a Gilead Company, Santa Monica, California, United States
- Xue, Wei, Kite, a Gilead Company, Santa Monica, California, United States
- Murakami, Jodi, Kite, a Gilead Company, Santa Monica, California, United States
- Bunton, Chandra, Kite, a Gilead Company, Santa Monica, California, United States
- Damico Khalid, Rita, Kite, a Gilead Company, Santa Monica, California, United States
- Dahiya, Saurabh, Stanford University, Stanford, California, United States
Description
Chronic autoimmune disorders like systemic lupus erythematosus (SLE) with or without lupus nephritis (LN), systemic sclerosis (SSc), and idiopathic inflammatory myopathies (IIM) are characterized by phenotypic and functional B-cell abnormalities, including loss of immune tolerance and development of auto-reactive B-cell clones (Pisetsky. Nat Rev Nephrol. 2023;19:509-24). Comprehensive and effective B-cell depletion may be achievable using KITE-363, a bicistronic, dual-targeting autologous anti-CD19/CD20 CAR T-cell therapy under investigation for B-cell lymphoma (Dahiya et al. ASCO 2025. Abstract 7003). This Phase 1 open-label basket study will evaluate the safety and preliminary efficacy of KITE-363 in up to approximately 52 patients aged ≥18 years with moderate-to-severe SLE with or without LN, SSc, or IIM that are refractory or intolerant to 1-2 prior non-glucocorticoid treatments. Additional disease-specific inclusion criteria apply. Key exclusion criteria include prior stem cell and/or organ transplant and prior cellular, gene, or T-cell engager therapy. Phase 1a involves KITE-363 sequential dose escalation to determine safety, tolerability, and the recommended Phase 1b dose; up to 12 patients (total across indications) will be evaluated across 2 planned dose levels. Phase 1b involves dose expansion to further evaluate safety and preliminary efficacy of KITE-363; up to 10 patients per indication (LN, SLE, SSc, IIM) will be treated at the recommended dose. Patients will undergo leukapheresis followed by optional corticosteroid bridging therapy. Lymphodepleting chemotherapy (fludarabine/cyclophosphamide) will be administered followed by a single KITE-363 infusion. The primary endpoint in Phase 1a is incidence of treatment-emergent adverse events, including dose-limiting toxicities. Primary endpoints in Phase 1b also include efficacy outcomes via disease-specific criteria. Select secondary endpoints include pharmacokinetic and pharmacodynamic assessments. The study is open and recruiting patients (NCT07038447).
LC and DF contributed equally.
Funding
- Commercial support: Kite, a Gilead Company.