Fate Therapeutics, Inc. (NASDAQ: FATE) announced on September 25, 2026, that it has been awarded a $15 million grant from the California Institute for Regenerative Medicine (CIRM) to support its Phase 2 clinical trial of FT819.
The funding comes through CIRM’s CLIN2 program, which is designed to advance clinical-stage product candidates with the potential to become transformative therapies. The award will specifically support the RECLAIM-LN trial, a Phase 2, potentially registrational study evaluating the safety and efficacy of FT819 in patients with refractory moderate-to-severe Systemic Lupus Erythematosus (SLE) and Lupus Nephritis (LN).
FT819 is an off-the-shelf, CD19-targeting chimeric antigen receptor (CAR) T-cell therapy. The company states that the therapy is designed to treat lupus by delivering deep and durable depletion of pathological B cells. The treatment is engineered to be administered as an outpatient procedure, aiming to broaden access beyond specialized treatment centers.
The RECLAIM-LN trial (FT819-201; NCT07570862) is a multicenter, open-label, single-arm study. It is expected to enroll approximately 53 patients who are refractory to at least two prior systemic immunosuppressive therapies. The primary endpoint of the study is the proportion of participants achieving a complete renal response at Week 26.
According to the filing, lupus nephritis affects approximately 150,000 patients in the United States and is a leading cause of morbidity and mortality among people living with the disease. The company notes that there is a significant unmet need for patients who are refractory to existing treatment options.
The trial was developed through interactions with the FDA, and FT819 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the agency. Additionally, the therapy has been selected for the FDA’s Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) program.
