Fate Therapeutics, Inc. (FATE), Monday announced that the U.S. Food and Drug Administration has granted Regenerative Medicine Advanced Therapy or RMAT designation to FT819, its off-the-shelf, iPSC-derived CAR T-cell therapy currently in Phase 1 clinical development for the treatment of moderate to severe systemic lupus erythematosus or SLE, including lupus nephritis.
Fate Therapeutics said the RMAT designation recognizes the potential of FT819 to address a significant unmet need in lupus care and provides enhanced regulatory support through increased interaction with the FDA during development.
The designation was granted based on initial safety and activity data from the company's ongoing multi-center Phase 1 clinical trial.
"RMAT designation recognizes the unique therapeutic potential of our off-the-shelf CAR T-cell therapy to address the unmet need of a wide range of lupus patients," said Bob Valamehr, President and Chief Executive Officer of Fate Therapeutics.
"Our goal with FT819 is to deliver a cost-effective, community-based treatment option that removes the burden of intense chemotherapy and extended hospitalization often associated with CAR T-cell therapy."
FT819 is the first-ever iPSC-derived CAR T-cell therapy to be evaluated in SLE.
The Phase 1 study is exploring a fludarabine-free conditioning regimen using either bendamustine or cyclophosphamide followed by a single infusion of FT819.
The company is currently expanding dosing at 360 million cells and evaluating safety and anti-B cell activity at a higher 900 million cell dose.
Fate Therapeutics expects to present additional Phase 1 clinical data for FT819 at major medical conferences in 2025.
The development program is supported by a $7.9 million grant from the California Institute for Regenerative Medicine or CIRM.
Fate noted that the RMAT designation provides an opportunity for early engagement with the FDA on key development topics, including surrogate endpoints and pathways to accelerated approval, and represents a meaningful step toward bringing off-the-shelf CAR T-cell therapy to broader patient populations.
Currently, FATE is trading at $0.92 down by 12.60 percent on the Nasdaq.
For comments and feedback: editorial@rttnews.com