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Fate Therapeutics Presents Updated Phase 1 Clinical Data of FT819 Off-the-shelf CAR T-cell Product Candidate for Systemic Lupus Erythematosus and Preclinical Advances in Next-Generation Off-the-Shelf CAR T-cell Programs
FT819 continues to demonstrate meaningful decrease in disease and favorable safety profile with twelve systemic lupus erythematosus (SLE) patients now
About this update from Fate Therapeutics, Inc.
[{"type":"text","content":"FT819 continues to demonstrate meaningful decrease in disease and favorable safety profile with twelve systemic lupus erythematosus (SLE) patients now treated; first systemic sclerosis (SSc) patient treated First ex-U.S. SLE patient treated with FT819 expands enrollment capacity and supports unique ability of FT819 for broad, on-demand patient accessibility Preclinical studies show FT836 chimeric antigen receptor (CAR) T cells uniquely targeting stress antigens MICA/B, combined with daratumumab, provide a comprehensive approach to treatment of multiple myeloma FT839 CAR T cells demonstrate the unique ability to treat a wide range of B-cell malignancies and autoimmune diseases through dual-CAR CD19/CD38 targeting without the need of conditioning chemotherapy in various preclinical models; combination with monoclonal antibodies or T-cell engager further expands targeting capacity SAN DIEGO, Dec. 08, 2025 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived off-the-shelf cellular immunotherapies to patients for broad accessibility, presented updated clinical data from its ongoing Phase 1 trial evaluating its FT819 off-the-shelf iPSC-derived CAR T-cell program in systemic lupus erythematosus (SLE) and unveiled new preclinical data from next-generation off-the-shelf iPSC-derived CAR T-cell programs for hematologic malignancies and autoimmune diseases at the 2025 American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando, Florida. “We are very pleased with the accelerating patient enrollment, the expansion of U.S. clinical sites, and the addition of international clinical sites, which together are enabling broader access to FT819 for patients suffering with lupus,” said Bob Valamehr, Ph.D., M.B.A., President and Chief Executive Officer of Fate Therapeutics. “The updated FT819 clinical data continue to demonstrate meaningful and durable responses with the use of less-intensive conditioning chemotherapy and a differentiated safety profile, reinforcing our goal to commence a registrational study for FT819 in 2026 and highlighting the potential of FT819 as an ideal CAR T-cell therapy for various autoimmune diseases. At the same time, our next-generation programs, FT836 and FT839...