Fate Therapeutics announces updated data for FT819

Fate Therapeutics (FATE) announced new and updated clinical data from the first five patients dosed with FT819 for the treatment of moderate-to-severe systemic lupus erythematosus at the European Alliance of Associations for Rheumatology, EULAR, 2025 Congress in Barcelona, Spain. The Company is currently conducting a multi-center, Phase 1 clinical trial of FT819, its off-the-shelf, CD19-targeted, 1XX CAR T-cell product candidate, for the treatment of patients with moderate-to-severe SLE, including lupus nephritis and extrarenal lupus. Specifically, in the five evaluable patients treated with FT819 for SLE as of the data cut-off date: there have been no events of ICANS, no events of GvHD, and one event of low-grade cytokine release syndrome; no dose-limiting toxicities were observed in any patient; and with no FT819 related severe adverse events observed, all patients were discharged following an initial short-duration hospitalization stay of three days, supporting the potential for outpatient administration. The Company has reached agreement with the U.S. Food and Drug Administration to allow for clinical investigation of multiple B cell-mediated autoimmune diseases under its current Phase 1 clinical trial of FT819, establishing the basis for conduct of a single Phase 1 basket study across autoimmune indications.