Fate Therapeutics Receives FDA Clearance of Investigational New Drug Application for FT839 Product Candidate

About this update from Fate Therapeutics, Inc.

First-of-Kind, Dual-CAR T cell Targeting CD19 and CD38 for Comprehensive Elimination of Complex, Multi-System Autoimmune Disorders Advances into Phase 1/2 Clinical Development Novel 13-point edited CAR T cell Built with a Suite of Genetic Edits and Manufactured as a Uniform Drug Product to Support Clinical Safety and Durable Efficacy in Autoimmune and Hematological Malignancies SAN DIEGO, July 09, 2026 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies broadly to patients with cancer and autoimmune disease, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for FT839, the Company’s next-generation, off-the-shelf CAR T-cell product candidate uniquely engineered to co-target CD19 and CD38. With IND clearance, the Company plans to advance FT839 into a basket clinical trial intended to evaluate the product candidate across a range of autoimmune diseases when administered in combination with standard-of-care therapy and without dependence on conditioning chemotherapy. Enrollment in the Phase 1/2 study is expected to commence in the second half of 2026. “FDA clearance of the FT839 IND is an important milestone that expands our off-the-shelf, iPSC-derived CAR T-cell platform capabilities for the comprehensive treatment of autoimmune disease, including rheumatoid arthritis,” said Bob Valamehr, Ph.D., M.B.A., President and Chief Executive Officer of Fate Therapeutics. “By co-targeting CD19 and CD38, FT839 is uniquely engineered to eliminate the full spectrum of aberrant, disease-driving immune cells, including B cells, plasma cells, and activated T cells, that are often the foundation of multicellular disease found in many autoimmune disorders as well as in hematological malignancies. In addition to the incorporation of multiple genetic edits to enhance performance and safety of the drug product, FT839 also includes our patented Sword & Shield™ technology which is designed to support durable activity without dependence on conditioning chemotherapy. The remarkably homogenous profile of FT839, a 13-point edited CAR T cell, is a testament to our distinct ability to genetically engineer cells and is enabled by our iPSC master ...

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