“Off-the-Shelf” CAR T-Cell Therapy for Myeloma Receives Fast Track Designation

The FDA has granted fast track designation to PBCAR269A, an allogeneic CAR T-cell therapy for the treatment of patients with relapsed or refractory MM whose disease failed to respond to two prior therapies, including an immunomodulatory agent and a proteasome inhibitor.

Unlike currently approved CAR T-cell therapies, PBCAR269A is a donor-derived therapy that uses T cells from healthy donors, which allows for the production of an “off-the-shelf” treatment. The therapy is being evaluated in an open-label, nonrandomized phase I/IIa trial at starting doses of 6×105 cells/kg, escalating to 6×106 cells/kg in subsequent cohorts.

PBCAR269A also received orphan drug designation. The treatment is being investigated in a phase I/IIa trial (NCT04171843) enrolling 48 participants across five U.S. institutions.

Sources: Precision BioSciences press release, September 21, 2020; ClinicalTrials.gov, NCT04171843.