Fate Therapeutics gets $15 million CIRM grant for lupus nephritis CAR T trial

Fate Therapeutics disclosed in an 8-K that on September 25, 2026, the California Institute for Regenerative Medicine awarded the company a $15 million grant to support its Phase 2 RECLAIM-LN clinical trial of FT819.¹ The company issued a press release the same day and filed it as Exhibit 99.1 to the current report.

The grant comes through CIRM's CLIN2 program, which the company said is a competitive funding opportunity designed to advance clinical-stage product candidates that have the potential to become transformative therapies while also addressing barriers to patient access.¹

RECLAIM-LN, also identified as FT819-201 and registered under NCT07570862, is a study testing FT819 in patients with SLE and lupus nephritis. According to the release, the trial is a multicenter Phase 2, open-label, single-arm trial designed to evaluate the efficacy and safety of FT819 in patients with refractory moderate-to-severe SLE with Class III or IV lupus nephritis (with or without concomitant class V).¹ The company said the study's target population involves approximately 53 patients who are refractory to at least two prior systemic immunosuppressive therapies.¹ The primary endpoint is the proportion of participants achieving complete renal response (CRR) at Week 26.¹

Fate said the RECLAIM-LN design was shaped through discussions with the FDA under FT819's Regenerative Medicine Advanced Therapy designation. The company also noted that FT819 has been accepted into an FDA pilot program covering chemistry, manufacturing, and controls, intended to provide opportunities for early and enhanced communication with the FDA regarding CMC readiness for therapies with accelerated clinical development timelines.¹

Fate Therapeutics is based in San Diego and describes itself as a clinical-stage biopharmaceutical company focused on iPSC-derived cellular immunotherapies for cancer and autoimmune disease.