Caribou Biosciences announces FDA clearance of IND application for CB-012

Caribou Biosciences announced that it received clearance of its Investigational New Drug, IND, application from the U.S. Food and Drug Administration, FDA, for CB-012, an allogeneic anti-C-type lectin-like molecule-1 CAR-T cell therapy. CB-012 will be evaluated in the multicenter, open-label, AMpLify Phase 1 clinical trial for patients with relapsed or refractory acute myeloid leukemia. “Clearance of our IND application for CB-012 represents another significant milestone for Caribou as our third off-the-shelf CAR-T cell therapy enters the clinic,” said Rachel Haurwitz, PhD, Caribou’s president and chief executive officer. “We look forward to initiating patient enrollment in the AMpLify Phase 1 trial by the middle of 2024 to evaluate the safety and tolerability of CB-012 in patients suffering from AML.”