FDA grants fast track designation to CD33-directed CAR-T for acute myeloid leukemia

The FDA granted fast track designation to PRGN-3006 for the treatment of adults with relapsed or refractory acute myeloid leukemia.
PRGN-3006 (Precigen Inc.) is an autologous, gene-edited chimeric antigen receptor T-cell therapy that targets the CD33 protein on the surface of cancer cells.
The investigational therapy — designed to reduce manufacturing time down to 1 day — is based on Precigen’s UltraCAR-T therapeutic platform.
The therapy uses the nonviral Sleeping Beauty gene-editing system to concurrently express the CD33-targeted CAR, membrane-bound interleukin-15, and a

The FDA granted fast track designation to PRGN-3006 for the treatment of adults with relapsed or refractory acute myeloid leukemia.
PRGN-3006 (Precigen Inc.) is an autologous, gene-edited chimeric antigen receptor T-cell therapy that targets the CD33 protein on the surface of cancer cells.
The investigational therapy — designed to reduce manufacturing time down to 1 day — is based on Precigen’s UltraCAR-T therapeutic platform.
The therapy uses the nonviral Sleeping Beauty gene-editing system to concurrently express the CD33-targeted CAR, membrane-bound interleukin-15, and a