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# Precigen Gains Orphan Status for CAR-T Therapy
- URL: https://www.fdaweb.com/precigen-gains-orphan-status-for-car-t-therapy/
- Published: 2020-01-07T12:00:00.000Z
- Updated: 2026-09-14T15:57:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145786

FDA has granted Precigen an orphan drug designation for PRGN-3006, a first-in-class investigational therapy for treating patients with relapsed or refractory acute myeloid leukemia (AML). PRGN-3006 uses Precigen’s UltraCAR-T therapeutic platform, which the company says “eliminates *ex vivo* expansion, reduces manufacturing time and provides the ability to administer CAR-T therapy to patients only one day after non-viral gene transfer at the cancer center.” PRGN-3006 is a multigenic CAR-T cell treatment designed to “co-express a chimeric antigen receptor, membrane-bound interleukin-15 (mbIL15), and a kill switch for better precision and control in targeting relapsed or refractory AML,” it says.