en.Wedoany.com Reported - Cellectis announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational allogeneic CAR-T cell therapy candidate targeting CD22, lasmecabtagene timgedleucel (lasme-cel), for the treatment of patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).

The RMAT designation was based on data from the Phase 1 BALLI-01 clinical trial, which demonstrated encouraging efficacy and a manageable safety profile. The final Phase 1 data from the BALLI-01 trial of lasme-cel will be presented in an oral session by Dr. Nitin Jain, Professor of Medicine in the Department of Leukemia at The University of Texas MD Anderson Cancer Center (Houston), at the 2026 European Hematology Association (EHA) Congress on June 13 from 5:15 PM to 6:30 PM Central European Time.

"As a pioneer in allogeneic CAR-T, the company believes that the RMAT designation for lasme-cel is a meaningful recognition of the need for an off-the-shelf CAR-T option for patients with relapsed or refractory B-ALL. As the company advances lasme-cel through key programs, this designation strengthens the company's dialogue with the FDA," said Dr. André Choulika, Co-founder and Chief Executive Officer of Cellectis.

The pivotal Phase 2 of the BALLI-01 trial is now open for enrollment. Information regarding participant eligibility and participating clinical centers is available on clinicaltrials.gov under trial number NCT04150497.

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