CB-010, an allogeneic anti-CD19 chimeric antigen receptor (CAR) T-cell therapy with a PD-1 knockout, was granted regenerative medicine advanced therapy (RMAT) designation for relapsed or refractory (R/R) large B-cell lymphoma (LBCL) and fast track designation for R/R B-cell non-Hodgkin lymphoma (B-NHL) by the U.S. Food and Drug Administration (FDA). The therapy was also previously granted orphan drug designation.
The recent designations were based on the results of an ongoing phase I trial, dubbed ANTLER. Patients enrolled in the trial had one of three LBCL subtypes: diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, or high-grade B-cell lymphoma.
Preliminary results showed a 100% complete response (CR) rate with dose level one of CB-010, with 50% of patients maintaining CR at six months. Results also showed the therapy to be well tolerated at dose level one.
“RMAT and fast track designations for CB-010 are important recognitions of the significant unmet patient need for an off-the-shelf cell therapy in the treatment of aggressive B-NHL,” said Rachel Haurwitz, PhD, president and chief executive officer of Caribou.
Source: Caribou Biosciences, November 29, 2022.