First patient dosed in an outpatient setting, discharged the same day; multiple patients in the process of screening at several activated sites

Trial advances FT819 toward a potential accelerated regulatory pathway supported by RMAT designation and participation in the FDA CMC Development and Readiness Pilot program

Study expected to enroll approximately 53 patients with refractory moderate-to-severe systemic lupus erythematosus (SLE) with Class III or IV lupus nephritis; study anticipated to complete enrollment in 15-18 months, by 1H2028

Patients to receive a single 900 million-cell dose of off-the-shelf FT819 following less-intensive conditioning with bendamustine; complete renal response at Week 26 is the primary endpoint

SAN DIEGO, Aug. 14, 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 off-the-shelf cellular immunotherapies to patients for broad accessibility, today highlighted the initiation of and treatment of the first patient in RECLAIM-LN (NCT07570862), its Phase 2 potentially registrational clinical trial of FT819 in patients with refractory moderate-to-severe systemic lupus erythematosus (SLE) with lupus nephritis.