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Rebecca Olin, MD, MS

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FDA Brief: New CAR T-Cell Therapy Granted Fast Track Designation in AML

By: Lauren Velentzas
Posted: Wednesday, April 13, 2022

The biopharmaceutical company Precigen recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PRGN-3006—an autologous, gene-edited T-cell therapy that targets CD33—for treatment of patients with relapsed or refractory acute myeloid leukemia (AML). The therapy uses the company’s UltraCAR-T therapeutic platform to express a chimeric antigen receptor (CAR) specifically targeting CD33, membrane-bound interleukin-15 for enhanced in vivo expansion and persistence, and a “kill” switch to conditionally eliminate CAR T cells.

The FDA previously granted PRGN-3006 Orphan Drug designation. The Fast Track designation comes as PRGN-3006 is being evaluated as part of a single-center phase I/IB dose-escalation/dose-expansion study. The study will enroll adults with relapsed or refractory AML receiving a single-therapy dose with or without prior lymphodepletion. Interim results from the study were presented at the 2021 American Society of Hematology Annual Meeting & Exposition. These results showed a 50% overall response rate among the first six patients in the lymphodepletion cohort and no dose-limiting toxicities. Of 15 patients, 1 experienced grade 3 cytokine-release syndrome.


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