Cellectis receives RMAT status from the FDA for lasmé-cel, the first allogeneic CAR-T therapy in a pivotal trial for patients with relapsed or refractory B-ALL

▤ Summary

Cellectis received FDA RMAT designation for lasmecabtagene timgedleucel, its allogeneic CAR-T candidate for relapsed or refractory B-cell acute lymphoblastic leukemia. The designation recognizes the therapy’s potential and is based on phase 1 data from the BALLI-01 trial. Cellectis says the result strengthens its ongoing discussions with the FDA as it advances the program through a pivotal phase 2 study that is now enrolling patients. The company also plans to present final phase 1 BALLI-01 results at the 2026 EHA Congress.

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