FDA clears IND application for allogeneic CAR-T to treat advanced multiple myeloma
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The FDA cleared an investigational new drug application for ALLO-605, a chimeric antigen receptor T-cell therapy for adults with relapsed or refractory multiple myeloma, according to the agent’s manufacturer.
ALLO-605 (Allogene Therapeutics) is an allogeneic, gene-edited CAR T-cell therapy that targets the B-cell maturation antigen 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 IND clearance will allow Allogene to begin enrollment in IGNITE, a phase 1 dose-escalation study of ALLO-605 in patients with relapsed or refractory multiple myeloma scheduled to begin in mid-2021, according to the manufacturer.
“Clearance of the ALLO-605 IND marks the beginning of the third stage of our three-pronged strategy targeting BCMA for relapsed or refractory multiple myeloma,” Rafael Amado, MD, executive vice president of research and development and chief medical officer of Allogene, said in a company-issued press release. “We look forward to initiating the IGNITE trial and are excited to advance a new technology platform that has the potential to transform the field of engineered T cell therapy.”
Allogene is conducting the phase 1 UNIVERSAL study examining another allogeneic BCMA-directed CAR-T (ALLO-715) in combination with a CD52-directed monoclonal antibody (ALLO-647; Allogene Therapeutics). The study also will evaluate ALLO-715 in combination with nirogacestat (SpringWorks Therapeutics) — a gamma secretase inhibitor — for patients with multiple myeloma.
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