SAN DIEGO — September 25, 2026
Fate Therapeutics announced that the California Institute for Regenerative Medicine (CIRM) has awarded the company a $15.0 million CLIN2 grant to support development of RECLAIM-LN, a Phase 2 potentially registrational trial of FT819 off-the-shelf CAR T-cell therapy in patients with refractory moderate-to-severe systemic lupus erythematosus (SLE) with lupus nephritis (LN). The competitive CLIN2 program is designed to support clinical-stage stem cell and gene therapy candidates with potential to address significant medical needs and patient-access challenges. The grant will support continued clinical development of FT819 as Fate evaluates an off-the-shelf cellular therapy approach for patients with severe lupus who have limited treatment options.
RECLAIM-LN Evaluates FT819 in Refractory Lupus Nephritis
RECLAIM-LN (FT819-201; NCT07570862) is a multicenter, open-label, single-arm Phase 2 trial designed to evaluate FT819 in patients with refractory moderate-to-severe SLE with Class III or IV lupus nephritis, with or without concomitant Class V disease. The study is expected to enroll approximately 53 patients who have failed at least two prior systemic immunosuppressive therapies. The primary endpoint is the proportion of patients achieving a complete renal response at Week 26, while secondary measures include disease activity and quality-of-life assessments. Lupus nephritis is a serious manifestation of SLE associated with kidney damage and can progress to kidney failure. Fate is evaluating whether FT819 can provide sustained depletion of pathological B cells and potentially enable patients to reduce or discontinue standard immunosuppressive treatment, although these potential benefits remain investigational.
FT819 Designed as Off-the-Shelf CD19 CAR T Therapy
FT819 is an investigational CD19-targeting CAR T-cell therapy derived from a precisely engineered clonal induced pluripotent stem cell (iPSC) master cell bank. Fate’s platform is intended to address manufacturing and availability limitations associated with patient- or donor-derived CAR T-cell products by enabling production of a standardized cellular therapy that can be stored and made available for treatment when needed. The company is developing FT819 as an off-the-shelf, on-demand therapy that could potentially expand CAR T-cell access beyond specialized treatment centers. Preliminary Phase 1 data cited by Fate demonstrated favorable safety and tolerability along with improvements across disease activity measures, including SLEDAI-2K and urine protein-to-creatinine ratio, with further reductions observed following less-intensive bendamustine conditioning. These early findings remain preliminary and require confirmation in larger controlled clinical studies.
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CIRM Funding Supports Phase 2 and Regulatory Development
RECLAIM-LN was developed through interactions with the FDA under FT819’s Regenerative Medicine Advanced Therapy (RMAT) designation. FT819 has also been selected for the FDA’s Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) program, providing opportunities for enhanced regulatory communication related to CMC readiness during accelerated development. The CIRM CLIN2 grant provides additional financial and development support as Fate advances the potentially registrational Phase 2 study. The collaboration reflects an effort to combine regenerative-medicine funding with clinical development of an off-the-shelf CAR T-cell approach for refractory lupus nephritis, while the ongoing RECLAIM-LN trial will determine the safety and clinical efficacy of FT819 in this patient population.
Source :Fate Therapeutics press release
