FDA grants fast track designation to allogeneic CAR-T for advanced multiple myeloma
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The FDA granted fast track designation to ALLO-605, a chimeric antigen receptor T-cell therapy for adults with relapsed or refractory multiple myeloma.
ALLO-605 (Allogene Therapeutics) is an allogeneic, gene-edited CAR T-cell therapy that targets the B-cell maturation antigen (BCMA) on the surface of cancer cells.
The therapy is derived from healthy donor-induced pluripotent stem cells and was developed using TurboCAR, Allogene’s proprietary platform based on programmable cytokine signaling that aims to improve the potency and function of CAR T cells.
The FDA’s fast track designation helps to expedite development, review and potential approval of treatments for serious or life-threatening diseases.
Enrollment in the IGNITE study of ALLO-605 began last year. The phase 1 dose-escalation trial is designed to evaluate the safety, feasibility and recommended phase 2 dose of ALLO-605 for patients with relapsed or refractory multiple myeloma or other BCMA-positive malignancies. The trial also uses ALLO-647 (Allogene Therapeutics) — a CD52-directed monoclonal antibody — as part of the study’s lymphodepletion regimen prior to ALLO-605 infusion.
Allogene is concurrently conducting the phase 1 UNIVERSAL study to assess another allogeneic BCMA-directed CAR-T (ALLO-715) in combination with ALLO-647. Researchers also will evaluate ALLO-715 in combination with nirogacestat (SpringWorks Therapeutics) — a gamma secretase inhibitor — for patients with multiple myeloma.
“We are very pleased with the continued momentum of our anti-BCMA portfolio for patients with multiple myeloma and look forward to making allogeneic CAR-T therapy a potential option for these patients,” Rafael Amado, MD, executive vice president of research and development and chief medical officer of Allogene, said in a company-issued press release. “With studies now underway for ALLO-715 alone and in combination with a gamma secretase inhibitor, as well as ALLO-605 as our next generation CAR T, we are taking an aggressive three-pronged approach aimed at exploring the unique attributes of [allogeneic] CAR-T therapies for patients with rapidly progressing disease.”
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