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Fate Therapeutics Presents New Phase 1 Clinical Data of FT819 Off-the-shelf, CAR T-cell Product Candidate for Systemic Lupus Erythematosus


Fate Therapeutics (NASDAQ: FATE)presented new Phase 1 clinical data for FT819, its off-the-shelf CAR T-cell therapy for systemic lupus erythematosus (SLE). Three patients with active lupus nephritis received fludarabine-free conditioning followed by a single dose of FT819 at 360 million cells.

The treatment showed promising results with no dose-limiting toxicities, no cytokine release syndrome, and no immune effector-cell associated neurotoxicity. All patients demonstrated rapid B-cell depletion, with the first patient achieving DORIS clinical remission at 6 months and remaining free of immunosuppressive therapy.
Based on these positive results, the company plans to initiate dose expansion at the first dose level to include up to 10 patients and escalate dosing to 720 million cells. Additionally, the first patient has been treated with FT819 as an add-on to maintenance therapy without conditioning chemotherapy.
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