(RTTNews) - Fate Therapeutics, Inc. (FATE), a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for FT839, an off-the-shelf CAR T-cell product candidate targeting CD19 and CD38.

Following the clearance, the company plans to advance FT839 into a Phase 1/2 basket trial to evaluate the candidate across a range of autoimmune diseases in combination with standard-of-care therapy and without dependence on conditioning chemotherapy. Enrollment in the study is expected to begin in the second half of 2026.

The initial autoimmune indications to be evaluated in the trial are Rheumatoid arthritis, ANCA-associated vasculitis, idiopathic inflammatory myositis, systemic lupus erythematosus with or without nephritis, and systemic sclerosis.

FT839 is a CAR T-cell product candidate designed to target CD19 and CD38 to eliminate disease-associated immune cells, including B cells, plasma cells, and activated T cells.

The candidate incorporates 13 genetic edits intended to enhance its performance and safety and includes the company's Sword & Shield technology, which is designed to support durable activity without dependence on conditioning chemotherapy.

The company also plans to investigate FT839 in Type 1 diabetes and multiple sclerosis through investigator-initiated trials and combine with therapeutic monoclonal antibodies to evaluate FT839 in hematologic malignancies, including B-cell lymphomas, leukaemia, and multiple myeloma.

FATE closed Thursday's trade up 6.14% to $3.11. In the overnight market, shares are trading up 0.64% to $3.13.

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