FDA grants fast track designation to CB-011 for the treatment of RRMM

On April 2023, the U.S. Food and Drug Administration (FDA) granted fast track designation to CB-‍011, an allogeneic anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy, for the treatment of relapsed/refractory multiple myeloma.¹

CB-011 is a genetically-engineered CAR T cell edited using CRISPR hybrid RNA-DNA.¹ These edits include inserting the anti-BCMA CAR into the T cell, removing the beta-2 microglobulin protein, and inserting a beta-2 microglobulin human leukocyte antigen fusion protein.² The engineering of this therapy aims to improve CAR T-cell persistence and antitumor response through the inhibition of T- and NK-mediated immune rejection.¹

CB-011 is currently being evaluated as part of the CaMMouflage phase I trial (NCT05722418). This trial is recruiting patients in the United States who have received at least three prior treatments (including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody) and have not received any previous CAR T-cell therapy. CaMMouflage has two primary outcomes:

• Part A, dose escalation; aims to establish the optimal therapeutic dosage.
• Part B, the expansion phase; records overall response rates to indicate efficacy in the treatment of relapsed/refractory multiple myeloma. Part B data will be evaluated using the International Myeloma Working Group (IMWG) response criteria.³