Cellectis Receives FDA RMAT Designation for Lasme-cel Therapy
Cellectis has received a Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for its lasme-cel therapy. This designation is for patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).
Biotechnology company Cellectis announced on June 9, 2026, that it has received a Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for its lasme-cel therapy. The designation applies to patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).
Lasme-cel is the first allogeneic, off-the-shelf CAR-T therapy to advance into a pivotal trial phase with the FDA. The RMAT designation is granted to advanced therapies intended to treat serious or life-threatening conditions where preliminary clinical evidence indicates a potential substantial improvement over available therapies.
Cellectis also presented final Phase 1 data for lasme-cel and preliminary data for etiasukel-cel (eti-cel) at the European Hematology Association (EHA) 2026 Congress. The company stated that lasme-cel demonstrated promising results in its pivotal trial, supporting the RMAT designation.
In addition to the RMAT news, Cellectis reported its first-quarter 2026 financial results in May. The company's annual general meeting of shareholders was held on June 25, 2026.