Cellectis Receives FDA RMAT Designation for Lasme-cel in r/r B-ALL

On June 9, 2026, Cellectis announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to lasmecabtagene timgedleucel (lasme-cel). Lasme-cel is a CD22-targeting allogeneic CAR-T cell therapy candidate intended for the treatment of patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). The RMAT designation is based on promising efficacy and safety data from the Phase 1 BALLI-01 clinical trial. This designation is intended to expedite the development and review of therapies for serious conditions and allows for increased dialogue with the FDA. Cellectis is currently enrolling patients in the pivotal Phase 2 portion of the BALLI-01 trial. Final Phase 1 data from the study are scheduled to be presented at the European Hematology Association (EHA) Congress on June 13, 2026. The company highlights that lasme-cel is the first allogeneic CAR-T therapy to enter a pivotal trial for this specific patient population.