FT839

July 9, 2026: Fate Therapeutics, Inc. (NASDAQ: FATE) said the FDA cleared its IND for FT839, an off-the-shelf iPSC-derived dual-CAR T-cell product engineered to co-target CD19 and CD38. The company plans to initiate a Phase 1/2 multi-indication “basket” clinical trial in autoimmune disease, with enrollment expected to begin in 2H 2026. The study is designed to assess safety, tolerability, and preliminary activity of FT839 with standard-of-care therapy, with or without conditioning chemotherapy, and is intended to generate Phase 1 and Phase 2-type data within a single trial.

Initial indications planned for the basket trial: rheumatoid arthritis, ANCA-associated vasculitis, idiopathic inflammatory myositis, systemic lupus erythematosus (with or without nephritis), and systemic sclerosis. Fate also expects investigator-initiated trials to explore FT839 in other autoimmune diseases including type 1 diabetes and multiple sclerosis.

The release cites preclinical data presented at 2026 ASGCT and EULAR showing FT839 eliminated B cells, plasma cells, and activated T cells (and hematologic cancer cells) as monotherapy and in combination with monoclonal antibodies and T-cell engagers; Sword & Shield technology was reported to support persistence without conditioning chemotherapy.

Fate noted FT819, a CD19-targeted off-the-shelf CAR T, is entering Phase 2 development in a potentially registrational trial in lupus nephritis.