Fate Therapeutics Secures $15M CIRM Grant for Lupus Nephritis Trial

Fate Therapeutics, a San Diego-based clinical-stage biopharmaceutical company specializing in induced pluripotent stem cell-derived immunotherapies, has received a $15 million grant from the California Institute for Regenerative Medicine (CIRM) under its CLIN2 program. The funding will support the RECLAIM-LN Phase 2 trial, evaluating FT819, an off-the-shelf CAR T-cell therapy designed to treat lupus nephritis—a kidney complication affecting around 150,000 Americans and a leading cause of kidney failure among lupus patients. The trial targets patients with refractory moderate-to-severe systemic lupus erythematosus (SLE) who have not responded to at least two prior systemic immunosuppressive therapies, aiming to enroll approximately 53 participants. The primary endpoint measures complete renal response at Week 26, with preliminary Phase 1 data indicating favorable safety and tolerability, alongside clinically meaningful improvements in disease activity measures, including the SLE Disease Activity Index (SLEDAI-2K) and urine protein-to-creatinine ratio. FT819 has received FDA Regenerative Medicine Advanced Therapy designation and is included in the agency’s Chemistry, Manufacturing, and Controls Development and Readiness Pilot program.