U.S. FDA grants fast track designation to CB-012 for the treatment of R/R AML

On September 3, 2024, the U.S. Food and Drug Administration (FDA) granted fast track designation to CB-012, an allogeneic anti-C-type lectin-like molecule (CLL)-1 chimeric antigen receptor (CAR) T-cell therapy, for the treatment of patients with relapsed/refractory acute myeloid leukemia.¹

CB-012 is an allogeneic CAR T-cell therapy that is engineered using clustered regularly interspaced short palindromic repeats (CRISPR) technology and uses checkpoint disruption and immune cloaking to exert antitumor activity.¹ CB-012 is currently being investigated in an ongoing phase I trial (AMpLify; NCT06128044).¹