PRGN-3006 UltraCAR-T Granted Fast Track Designation

PRGN-3006 UltraCAR-T, a multigenic chimeric antigen receptor (CAR) T-cell therapy, has received Fast Track Designation from the FDA for patients with relapsed or refractory AML.

According to a company statement, PRGN-3006 UltraCAR-T is designed to “overcome limitations of currently available CAR-T therapies by utilizing an advanced overnight non-viral gene delivery manufacturing process at a medical center’s facility without the need for ex vivo expansion.”

The therapy uses the company’s non-viral Sleeping Beauty system to express a CAR specifically targeting CD33, membrane-bound interleukin-15, and a kill switch to conditionally eliminate CAR T-cells for an improved safety profile.

To date, PRGN-3006 UltraCAR-T has demonstrated a favorable safety profile with no dose-limiting toxicities or neurotoxicity.

Source: Precigen press release, April 2022