FDA grants fast track designation to donor-derived CAR-T for advanced kidney cancer

The FDA granted fast track designation to ALLO-316, an investigational chimeric antigen receptor T-cell therapy, for the treatment of adults with advanced or metastatic clear cell renal cell carcinoma.

ALLO-316 (Allogene Therapeutics) is an allogeneic, gene-edited CAR T-cell therapy that targets the protein CD70 on the surface of cancer cells. The agent is derived from donor induced pluripotent stem cells and uses proprietary transcription activator-like effector nucleases (TALEN) gene editing technology (Cellectis) to disrupt the CD52 gene.

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