Caribou Biosciences says FDA grants Fast Track designations to CB-010

Caribou Biosciences announced that the U.S. Food and Drug Administration granted Fast Track designations to CB-010 for refractory systemic lupus erythematosus and to CB-012 for relapsed or refractory acute myeloid leukemia. CB-010, an allogeneic anti-CD19 CAR-T cell therapy, will be evaluated in the GALLOP Phase 1 clinical trial in patients with lupus nephritis and extrarenal lupus, subcategories of SLE. The GALLOP clinical trial is on track to initiate by year-end 2024. CB-012, an allogeneic anti-CLL-1 CAR-T cell therapy, is being evaluated in the company’s ongoing AMpLify Phase 1 clinical trial in patients with r/r AML.