FDA grants fast track designation to donor-derived CAR-T for advanced kidney cancer
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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.
The cell therapy is given in combination with ALLO-647 (Allogene Therapeutics) — an anti-CD52 monoclonal antibody — to provide selective and prolonged lymphodepletion that may delay graft rejection.
The FDA's fast track designation helps to expedite development, review and potential approval of treatments for serious or life-threatening diseases.
“Metastatic solid tumors have historically been a challenge to treat regardless of treatment modality, creating a large unmet need for patients and a necessity for scientific innovation,” Rafael Amado, MD, executive vice president of research and development and chief medical officer for Allogene, said in a company-issued press release.
“We have our sights set on confronting solid tumors, where the need is unquestionably high,” Amado added. “We remain optimistic for the potential of our AlloCAR T platform to address the challenge, and we look forward to generating data from our ongoing phase 1 trial.”
Allogene is enrolling patients in the TRAVERSE trial, designed to evaluate the safety and feasibility of ALLO-316 — in combination with lymphodepletion chemotherapy and ALLO-647 — among adults with advanced or metastatic clear cell renal cell carcinoma. The multicenter phase 1 dose-escalation study includes patients who have advanced or metastatic disease after treatment with immune checkpoint or VEGF inhibitors.
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