Fate Therapeutics Wins FDA IND Clearance for Gene-Edited Dual-CAR T-Cell Therapy in Autoimmune Disease

Fate Therapeutics announced FDA clearance of its IND application for FT839, a next-generation, off-the-shelf iPSC-derived CAR T-cell candidate engineered with numerous genetic edits to co-target CD19 and CD38. The Phase 1/2 multi-indication basket trial will evaluate FT839, administered with standard-of-care therapy (with or without conditioning chemotherapy), in patients with autoimmune diseases including rheumatoid arthritis and lupus. Enrollment is expected to begin in the second half of 2026.