Fate Therapeutics Gets FDA Clearance for FT839 Autoimmune CAR-T Therapy

Fate Therapeutics has received FDA clearance for FT839, an allogeneic CAR-T therapy targeting both CD19 and CD38 to address multi-system autoimmune disorders where single-antigen approaches fail. The platform combines dual chimeric antigen receptors on a single iPSC-derived cell product, projected at $20,000–$40,000 per patient versus $100,000–$150,000 for autologous CAR-T, and is designed to eliminate conditioning chemotherapy in Phase 1/2 trials beginning H2 2026.

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