FDA Grants RMAT and Fast Track Designations to Allogeneic CAR T-Cell Therapy for B-NHL
The FDA granted CB-010, an allogeneic chimeric antigen receptor (CAR) T-cell therapy regenerative medicine advanced therapy (RMAT) designation for patients with relapsed or refractory large B cell lymphoma (LBCL) and fast track designation for patients with relapsed or refractory B cell non-Hodgkin lymphoma (R/R B-NHL), according to a press release from Caribou Biosciences, Inc.1
CB-010, an allogeneic anti-CD19 CAR-T cell therapy, is being evaluated in the ongoing ANTLER phase 1 clinical trial (NCT04637763) in patients with R/R B-NHL. The FDA designations are based on the outcomes of 6 patients evaluated at dose level 1 who all had a complete response (CR), with 3 out of 6 patients maintaining a durable complete response at 6 months.
“We are encouraged that CB-010 has demonstrated early potential as an off-the-shelf cell therapy that may meaningfully rival autologous cell therapies,” Rachel Haurwitz, PhD, Caribou’s president and chief executive officer, said in a statement.
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