Fate Therapeutics recently announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for the lupus treatment candidate FT819. This designation signifies that a therapy meets specific requirements and is promising enough that the FDA wants to help move it through development faster. This is a cell therapy that Fate Therapeutics has been developing to treat active moderate to severe Systemic Lupus Erythematosus (SLE), including lupus nephritis (LN). Fate Therapeutics has partnered with The Lupus Foundation of America to develop the early, ongoing study of FT819.
FT819 is an off-the-shelf, iPSC-derived CD19 CAR-T cell therapy aiming to treat lupus through tissue trafficking and the elimination of B-cells. FT819 is currently part of an ongoing Phase I study, with dose expansion efforts continuing to evaluate efficacy. This expansion stage does not include fludarabine (flu), and instead will use bendaumustine or cyclophosphamide alone for conditioning, followed by a single dose of FT819. Fate Therapeutics is also assessing higher doses for safety, pharmacokinetics and anti B-cell activity, further highlighting FT819’s potential in becoming a new treatment option for SLE.
The Lupus Foundation of America has partnered with Fate Therapeutics as part of the California Institute for Regenerative Medicine Grant. This collaboration focuses on the development of a Phase I study of FT819 in those with moderate to severe active SLE. The Lupus Foundation of America is leading efforts to ensure equitable and diverse participation in the clinical trial. The LFA’s approach includes formative evaluations, key informant interviews, advisory board involvement, and in-person meetings to ensure that Fate Therapeutics is engaged in subject-focused drug development that’s informed by diverse perspectives on clinical trials.
Additional research and further advancements of this study continues. Learn more about FT819 here.
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