Fate Therapeutics Updates FT819 Clinical Data

Fate Therapeutics 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 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 Annual Meeting & Exposition in Orlando, Florida. Key highlights: FT819 continues to demonstrate meaningful decrease in disease and favorable safety profile with twelve systemic lupus erythematosus patients now treated; first systemic sclerosis 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 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