Fate Therapeutics, Inc. (FATE), a clinical-stage biopharmaceutical company developing iPSC-derived cellular immunotherapies, announced that the California Institute for Regenerative Medicine (CIRM) has awarded the company a $15.0 million CLIN2 grant. The funding will support the clinical advancement of FT819, an off-the-shelf CD19-targeting CAR T-cell therapy, for the treatment of lupus nephritis.
The grant underwrites the RECLAIM-LN study, a Phase 2, potentially registrational trial evaluating FT819 in patients with refractory moderate-to-severe systemic lupus erythematosus (SLE) accompanied by lupus nephritis. Lupus nephritis is a severe complication of SLE and a primary driver of kidney failure within the lupus population, affecting an estimated 150,000 individuals in the United States.
Designed as a multicenter, open-label, single-arm Phase 2 trial, RECLAIM-LN expects to enroll approximately 53 patients who have failed to respond to at least two prior systemic immunosuppressive therapies. The primary endpoint measures the proportion of participants achieving a complete renal response at Week 26, with key secondary endpoints assessing disease activity and quality of life.
Preliminary Phase 1 data demonstrated a favorable safety and tolerability profile, alongside improvements in disease activity markers such as SLEDAI-2K scores and urine protein-to-creatinine ratios. The company also observed further reductions in these measures utilizing a less-intensive bendamustine conditioning regimen.
FT819 is engineered from a precisely modified clonal induced pluripotent stem cell (iPSC) master bank, enabling manufacturing at scale, cryopreservation, and on-demand availability. This platform eliminates the need for patient-specific or donor-derived cell collection, a significant logistical advantage over autologous CAR T-cell approaches.
The RECLAIM-LN program was shaped through interactions with the FDA under FT819’s Regenerative Medicine Advanced Therapy (RMAT) designation. Additionally, FT819 has been selected for the FDA’s Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot program, intended to accelerate the development of regenerative medicine products.