California Granted Fate Therapeutics $15 Million for Lupus
The funding supports a Phase 2 trial of an off-the-shelf CAR T cell therapy for severe systemic lupus.
Updated on Sept. 28, 2026 in Biotech
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The California Institute for Regenerative Medicine has awarded Fate Therapeutics a $15.0 million grant to advance the RECLAIM-LN Phase 2 clinical trial. This research-stage study evaluates FT819, an off-the-shelf CAR T cell therapy, in patients with refractory systemic lupus erythematosus and lupus nephritis.
Why it matters
The grant aims to accelerate the development of potential therapies while addressing barriers to patient access in clinical research. This funding supports the investigation of a treatment for a condition currently affecting approximately 150,000 people in the United States.
The study evaluates FT819, an off-the-shelf CAR T cell therapy, in an open-label, single-arm, multicenter design involving 53 patients. The primary endpoint for complete renal response is measured at Week 26.
The players
Fate Therapeutics
A biotechnology company focused on the development of off-the-shelf cellular immunotherapies derived from induced pluripotent stem cells.
California Institute for Regenerative Medicine
The state agency tasked with funding stem cell research and regenerative medicine clinical trials in California.
The details
FT819 is an off-the-shelf CAR T cell therapy—a treatment where immune cells are engineered to recognize and destroy specific disease-causing cells—designed for patients refractory to at least two prior immunosuppressive treatments. The RECLAIM-LN trial utilizes an open-label, single-arm design, meaning all participants receive the treatment without a placebo group to evaluate the therapy's safety and effectiveness in patients with systemic lupus erythematosus and lupus nephritis.
Timeline
Week 26 marks the primary endpoint measurement for complete renal response.
The Tech Race
This development marks a significant move in the competitive landscape for off-the-shelf cellular therapies targeting autoimmune diseases. It follows the regulatory guidance provided by the FDA Chemistry, Manufacturing, and Controls Development and Readiness Pilot program.
This Phase 2 trial is currently limited to patients with refractory systemic lupus who have exhausted at least two prior immunosuppressive therapies. Prospective participants should consult with their healthcare providers regarding enrollment eligibility for the 53-patient study.
The takeaway
The success of this trial depends on meeting the primary renal response endpoint at the Week 26 mark. Stakeholders should monitor trial enrollment milestones and future safety data reported by Fate Therapeutics for updates on the therapy's trajectory.
Further reading
Find more clinical developments in the Biotech section.
Source note: This article includes information reported by Pharmabiz.
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