Cellectis: FDA Grants RMAT Status to Lasmé-cel for B-Cell ALL Leukemia
The U.S. FDA has granted Regenerative Medicine Advanced Therapy (RMAT) status to lasmé-cel, an allogeneic CAR-T candidate from Cellectis targeting the CD22 antigen for the treatment of patients with relapsed or refractory B-cell acute lymphoblastic leukemia. This designation is based on phase 1 data from the BALLI-01 trial, presented on Saturday at the European Hematology Association congress.
FDA Recognition of Therapeutic Potential
The RMAT status granted by the FDA reflects the recognition of the potential of lasmé-cel to meet the unmet medical needs of patients with relapsed or refractory B-cell acute lymphoblastic leukemia. This designation is based on phase 1 clinical trial data from BALLI-01, which demonstrates promising efficacy associated with a manageable tolerance profile.
The status also strengthens the dialogue with the FDA as Cellectis advances lasmé-cel in its pivotal program. According to Dr. André Choulika, co-founder and CEO of Cellectis, this achievement recognizes 'the importance of providing off-the-shelf CAR-T options to patients with relapsed or refractory B-ALL who cannot afford to wait'.
Phase 2 Pivotal Trial Open for Recruitment
The phase 2 pivotal trial BALLI-01 is currently open for recruitment. Information on eligible patients and participating clinical centers is available on the clinicaltrials.gov registry, under the number NCT04150497.
Lasmé-cel represents Cellectis' allogeneic CAR-T candidate targeting the CD22 antigen. The biotech positions itself as a pioneer in allogeneic CAR-T technologies, developing ready-to-use engineered CAR‑T cell immunotherapy products for the treatment of cancer patients.
