First iPSC-derived CAR-T cell therapy: IND approved by FDA
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Last Update: 2020-07-16
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Source: Internet
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Author: User
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!---- Fate Therapeutics, a clinical-phased biopharmaceutical company dedicated to the development of cellular immunotherapy against cancer and immune diseases, announced today that the FDA has approved the application for a new research drug for FT819 (IND)FT819 is a CAR-T cell therapy derived from cd-19 plus malignancies derived from induced pluripotent stem cells (iPSC) designed to improve the safety and effectiveness of CAR-T cell therapyFate Therapeutics plans to launch Phase I clinical trials of FT819 to treat recurrent, refracted B-cell malignancies, including chronic lymphocytic leukemia (CLL), acute lymphoblastic leukemia (ALL) and non-Hodgkin's lymphoma (NHL)multicenter Phase I clinical trial stakes are designed to determine the maximum tolerable dose of FT819 and to assess the safety and clinical activity of FT819 for the treatment of three B-cell malignancies (CLL, ALL and NHL)each indication will be independently registered and evaluated for three dose incrementsFT819 is designed to address a number of current limitations of CAR-T cell therapyuse iPSC cell lines as a starting source, which enables CAR-T cells to be mass produced and delivered to patients
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