Fate Therapeutics, Inc. (NASDAQ: FATE) has received a $15.0 million grant from the California Institute for Regenerative Medicine (CIRM) to support RECLAIM-LN, its Phase 2 clinical trial of FT819, an off-the-shelf CAR T-cell therapy targeting refractory moderate-to-severe lupus nephritis (LN).

The grant was awarded through CIRM's competitive CLIN2 program, which funds clinical-stage stem cell and gene therapy candidates. The review process includes scientific evaluation by expert panels.

RECLAIM-LN (NCT07570862) is a multicenter, open-label, single-arm trial expected to enroll approximately 53 patients who have not responded to at least two prior systemic immunosuppressive therapies. The primary endpoint is complete renal response at Week 26. LN affects approximately 150,000 patients in the United States and is a leading cause of kidney failure among people with systemic lupus erythematosus (SLE).

FT819 is a CD19-targeting CAR T-cell product candidate derived from an induced pluripotent stem cell (iPSC) bank, designed for off-the-shelf availability. The trial was developed in consultation 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 program.

Preliminary data from the Phase 1 study showed favorable safety and tolerability, along with improvements in disease activity measures, including clinical SLEDAI-2K scores and urine protein-to-creatinine ratio.

"The CIRM Board's award to Fate Therapeutics for its Phase 2 clinical trial of FT819 represents a significant step forward in transforming the clinical practice for patients living with a severe form of lupus," said Sohel Talib, PhD, Senior Fellow in Clinical Development at CIRM.

According to the press release, this is the second CIRM grant supporting FT819 development, with prior funding noted under grant number CLIN2-16303 and the current award under CLIN2-20291.