Fate Therapeutics Reports Promising Phase 1 Results for Off-the-Shelf CAR T-Cell Therapy in Lupus

Reuters12-08

Fate <a href="https://laohu8.com/S/LENZ">Therapeutics</a> Reports Promising Phase 1 Results for Off-the-Shelf CAR T-Cell Therapy in Lupus

Fate Therapeutics Inc. has presented updated clinical data from its ongoing Phase 1 trial evaluating FT819, an off-the-shelf iPSC-derived CAR T-cell product candidate, in patients with systemic lupus erythematosus $(SLE)$. The data, presented at the 2025 American Society of Hematology $(ASH)$ Annual Meeting & Exposition, include results from 13 enrolled patients-12 with SLE and one with systemic sclerosis. The updated findings show sustained clinical responses, durable B-cell depletion, and a favorable safety profile without the need for intensive-conditioning chemotherapy. Fate Therapeutics also announced preclinical advances in its next-generation off-the-shelf CAR T-cell programs, FT836 and FT839, targeting hematologic malignancies and autoimmune diseases. The company is preparing for a registrational study of FT819 in 2026 and is in discussions with the U.S. FDA under the Regenerative Medicine Advanced Therapy (RMAT) designation.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Fate Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9598307-en) on December 08, 2025, and is solely responsible for the information contained therein.

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The data, presented at the 2025 American Society of Hematology $(ASH)$ Annual Meeting & Exposition, include results from 13 enrolled patients-12 with SLE and one with systemic sclerosis. The updated findings show sustained clinical responses, durable B-cell depletion, and a favorable safety profile without the need for intensive-conditioning chemotherapy. Fate Therapeutics also announced preclinical advances in its next-generation off-the-shelf CAR T-cell programs, FT836 and FT839, targeting hematologic malignancies and autoimmune diseases. The company is preparing for a registrational study of FT819 in 2026 and is in discussions with the U.S. FDA under the Regenerative Medicine Advanced Therapy (RMAT) designation.\n      \n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. 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