The U.S. Food and Drug Administration (FDA) has granted fast track designation to ALLO-605 for the treatment of adult patients with relapsed or refractory multiple myeloma (MM).
ALLO-605 is an allogeneic, gene-edited, B-cell maturation antigen (BCMA)─targeted chimeric antigen receptor (CAR) T-cell therapy derived from healthy donor T cells.
The phase I IGNITE study evaluating the safety, feasibility, and recommended phase II dose of ALLO-605 began enrolling patients with relapsed or refractory MM, or other BCMA-positive malignancies, last year. The IGNITE study will also examine CD52-directed monoclonal antibody ALLO-647 as part of a lymphodepletion regimen prior to starting treatment with ALLO-605.
In April 2021, the FDA granted Regenerative Medicine Advanced Therapy designation to another of the manufacturer’s allogeneic BCMA-directed CAR T-cell therapies based on initial results from the phase I UNIVERSAL study evaluating ALLO-715 in patients with relapsed/refractory MM, which were presented at the 2020 American Society of Hematology (ASH) Annual Meeting.
Source: Allogene Therapeutics press release, June 30, 2021.