Fate Therapeutics Inc

Fate Therapeutics announced the U.S. Food and Drug Administration cleared its Investigational New Drug application for FT839, an off-the-shelf CAR T-cell product candidate targeting CD19 and CD38. The company plans to advance FT839 into a Phase 1/2 basket trial evaluating the candidate across multiple autoimmune diseases in combination with standard-of-care therapy and without conditioning chemotherapy, with enrollment expected to begin in the second half of 2026. Initial indications include rheumatoid arthritis, ANCA-associated vasculitis, idiopathic inflammatory myositis, systemic lupus erythematosus with or without nephritis, and systemic sclerosis. FT839 incorporates 13 genetic edits and the company's Sword & Shield technology to enhance performance and safety. Fate Therapeutics also plans investigator-initiated trials in type 1 diabetes and multiple sclerosis, and combination studies with therapeutic monoclonal antibodies in hematologic malignancies.

Fate Therapeutics announced that preliminary clinical data from its off-the-shelf CAR T-cell product candidate FT819 will be presented at the ISSCR 2026 Annual Meeting in Montréal on July 9. The presentation covers the systemic sclerosis arm of an ongoing Phase 1 basket trial, with data from the first four patients as of a June 12, 2026 cutoff. Three patients received less-intensive conditioning chemotherapy and one received no conditioning, and all showed a Revised Composite Response Index in Systemic Sclerosis of 25 or higher with meaningful mean improvement in the Modified Rodnan Skin Score at three months. No cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, graft versus host disease, hypogammaglobulinemia, or deaths were reported. The company is also evaluating FT819 in systemic lupus erythematosus and plans a potentially registrational Phase 2 trial in lupus nephritis.