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Fate Therapeutics Announces Updated Clinical Data for FT819 Off-the-shelf CAR T-cell Product Candidate Demonstrating Durability of Drug-free Remission for Severe Lupus Nephritis at EULAR 2025 Congress
All three patients treated with FT819 following fludarabine-free conditioning regimen for severe lupus nephritis achieve Primary Efficacy Renal Response
About this update from Fate Therapeutics, Inc.
[{"type":"text","content":"All three patients treated with FT819 following fludarabine-free conditioning regimen for severe lupus nephritis achieve Primary Efficacy Renal Response (PERR); first patient to reach 1-year follow-up continues in drug-free Definition of Remission in SLE (DORIS) First extrarenal SLE patient on maintenance therapy treated with FT819 in the absence of conditioning achieves Low Lupus Disease Activity State (LLDAS) at 3-month follow-up and maintained at 6 months Cumulative clinical experience in nearly 60 patients treated with off-the-shelf program across autoimmunity and oncology continues to support therapeutic differentiation with favorable safety profile and short duration of hospitalization SAN DIEGO, June 11, 2025 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived off-the-shelf cellular immunotherapies to patients, today announced new and updated clinical data from the first five patients dosed with FT819 for the treatment of moderate-to-severe systemic lupus erythematosus (SLE) at the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress in Barcelona, Spain. “The initial clinical profile of our FT819 off-the-shelf CAR T-cell program in moderate-to-severe SLE has shown clear therapeutic differentiation as all five patients achieved significant disease improvement with either less-intensive or no conditioning chemotherapy, with the first patient to reach 12-month follow-up showing durable drug-free remission,” said Bob Valamehr, Ph.D. MBA, President and Chief Executive Officer of Fate Therapeutics. “We remain focused and have made good progress on growing our clinical footprint in the U.S. and Europe to accelerate the pace of patient enrollment in our FT819 program in lupus, as well as in myositis, systemic sclerosis and ANCA-associated vasculitis. With promising preliminary clinical data, a favorable safety profile, shortened hospitalization requirements, reduced or no conditioning chemotherapy regimens, and unique on-demand product availability with low cost of goods, we believe FT819 is not only well-suited for administration in academic settings but also an ideal drug product to support treatment in the community setting, facilitating broad patient access and ...