The US Food and Drug Administration has granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations to CB-010, an experimental allogeneic anti-CD19 chimeric antigen receptor (CAR)-T cell therapy, for the treatment of several forms of lymphoma including diffuse large B-cell lymphoma (DLBCL), according to a press release from the developer of CB-010, Caribou Biosciences.

The treatment received RMAT designation for the treatment of relapsed or refractory large B-cell lymphoma (LBCL) and Fast Track designation for relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL).

Read more about experimental DLBCL therapies

“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,” Rachel Haurwitz, PhD, Caribou’s president and chief executive officer, said.

The experimental therapy is currently being investigated in an ongoing phase 1 clinical trial called ANTLER (NCT04637763), which will enroll patients with 3 subtypes of LBCL, including DLBCL, primary mediastinal large B-cell lymphoma, and high-grade B-cell lymphoma.

New 12-month data from the first cohort (n=6) of patients enrolled in the trial at an initial infusion dose of 40×106 cells showed that all patients achieved complete response (CR), with 3 patients maintaining CR at 6 months and 2 patients with CR at 12 months. The first patient enrolled in the study has achieved over 18 months of CR.

The investigational treatment was generally well tolerated at dose level 1 and a second, higher dose of 80×106 cells given to 3 additional patients. The study is currently enrolling patients for a third dose of 120×106 cells.

“The early results from the ANTLER trial are promising and I look forward to enrolling additional patients in this trial to learn more about the potential of CB-010 as an off-the-shelf treatment option for patients with aggressive B-NHL who have a high unmet medical need,” Susan O’Brien, MD, professor of medicine at Chao Family Comprehensive Cancer Center at the University of California, Irvine and presenting investigator of the ANTLER clinical trial, said. 

CB-010 uses a genome-editing strategy of PD-1 knockout to improve the persistence of antitumor activity through the reduction of premature CAR-T cell exhaustion.

References

Caribou Biosciences announces the FDA granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations to CB-010, an allogeneic anti-CD19 CAR-T cell therapy. News release. Caribou Biosciences, Inc; November 29, 2022.

Caribou Biosciences reports CB-010 ANTLER phase 1 trial progress. News release. Caribou Biosciences, Inc; December 12, 2022.