Fate Therapeutics’ FT819 CAR T-cell Therapy Receives FDA RMAT Designation for Lupus Treatment

SAN DIEGO, April 14, 2025 (GLOBE NEWSWIRE) — Fate Therapeutics, Inc. (NASDAQ: FATE),a clinical-stage biopharmaceutical company advancing iPSC-derived off-the-shelf cellular immunotherapies, today announced the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to FT819. This investigational CAR T-cell therapy is being evaluated in a Phase 1 clinical trial for moderate to severe systemic lupus erythematosus (SLE), including lupus nephritis (LN).

“This RMAT designation underscores the transformative potential of FT819 for lupus patients,” stated Bob Valamehr, Ph.D., MBA, President and CEO of Fate Therapeutics. “Our off-the-shelf approach aims to deliver accessible, on-demand CAR T-cell therapy, reducing patient burden and expanding treatment options, even in underserved communities. We look forward to collaborating closely with the FDA to accelerate FT819’s development.”

The RMAT designation was based on promising initial safety and activity data from Fate Therapeutics’ ongoing Phase 1 trial. This trial explores a fludarabine-free conditioning regimen followed by a single FT819 dose. The company is currently expanding enrollment at 360 million cells and escalating doses to 900 million cells. Further clinical data will be presented at upcoming scientific meetings in 2025. The trial is supported by a $7.9 million grant from the California Institute for Regenerative Medicine (CIRM).

RMAT designation, established under the 21st Century Cures Act, expedites the development of regenerative therapies for serious conditions. It includes benefits like early FDA interactions and potential priority review, accelerating FT819’s pathway to patients.

Fate Therapeutics’ iPSC Platform: Revolutionizing Cell Therapy

Fate Therapeutics’ proprietary iPSC platform enables the creation of off-the-shelf cellular immunotherapies. By leveraging engineered, clonal master iPSC lines, the company can produce standardized, readily available cell therapies, overcoming limitations of patient-derived treatments. This platform, backed by a robust intellectual property portfolio, aims to broaden access to advanced cell therapies.