Fate Therapeutics Gets FDA IND Clearance for 13-Edited FT839, Phase 1/2 Set for H2 2026
FATE•Fate Therapeutics received FDA clearance for its FT839 IND, enabling Phase 1/2 launch in H2 2026; the off-the-shelf CAR T-cell candidate features 13 genetic edits, dual CD19/CD38 targeting and Sword & Shield™ safety technology. The basket trial will assess FT839’s safety and efficacy across multiple autoimmune diseases without conditioning chemotherapy.
1. FDA IND Clearance and Trial Launch
Fate Therapeutics has secured FDA clearance for its Investigational New Drug application for FT839, its off-the-shelf, iPSC-derived CAR T-cell candidate. This clearance enables the company to initiate a Phase 1/2 basket trial in the second half of 2026, with enrollment planned across multiple autoimmune disease cohorts.
2. FT839 Product Engineering and Features
FT839 is engineered with 13 targeted genetic edits, including dual CD19 and CD38 chimeric antigen receptors, Sword & Shield™ alloimmune defense technology, a high-affinity CD16 Fc receptor, CD3ε fusion receptor, synthetic CXCR2 chemokine receptor and other modifications designed to enhance safety, persistence and broad targeting of pathogenic immune cells.
3. Phase 1/2 Basket Trial Design
The upcoming Phase 1/2 basket trial will evaluate FT839 in combination with standard-of-care therapies without the need for conditioning chemotherapy. The study design allows assessment of both safety and preliminary efficacy across diverse autoimmune indications—such as rheumatoid arthritis and lupus nephritis—in a single, accelerated development pathway.
