Cellectis Receives FDA RMAT Designation for Leukemia CAR-T Candidate
Cellectis announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to its allogeneic CAR-T cell therapy candidate, lasme-cel, for r/r B-ALL.
Cellectis has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for its allogeneic CAR-T cell therapy candidate, lasmecabtagene timgedleucel (lasme-cel). The therapy is intended for patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).
The RMAT designation signifies the FDA's recognition of lasme-cel's potential to address an unmet medical need in this patient population. This designation is supported by early Phase 1 data from the BALLI-01 trial, which indicated promising efficacy and a manageable safety profile.
Cellectis, a company focused on developing allogeneic CAR-T therapies, views the RMAT designation as validation for the need for 'off-the-shelf' CAR-T options for patients who require immediate treatment. The company is advancing lasme-cel through its pivotal development program.
Final Phase 1 data from the BALLI-01 trial will be presented at the upcoming European Hematology Association Congress. The pivotal Phase 2 BALLI-01 trial is currently enrolling patients.