Cellectis (Euronext Growth: ALCLS - NASDAQ: CLLS) announced the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy designation to lasmecabtagene timgedleucel, its CD22-targeting allogeneic CAR-T cell therapy product candidate.

The designation applies to treatment of patients with relapsed or refractory B-cell acute lymphoblastic leukemia. The FDA designation is supported by Phase 1 BALLI-01 data showing efficacy and safety profile results.

Final Phase 1 data from the BALLI-01 trial will be presented at the 2026 Congress of the European Hematology Association on June 13 at 5:15-6:30pm CET. The presentation will be delivered by Nitin Jain, Professor of Medicine in the Department of Leukemia at MD Anderson Cancer Center.

"As the company that pioneered allogeneic CAR-T, we see the RMAT designation for lasme-cel as a meaningful recognition of the need for off-the-shelf CAR-T options for patients with relapsed or refractory B-ALL, patients who cannot wait," said André Choulika, Co-founder and Chief Executive Officer of Cellectis.

The BALLI-01 trial Pivotal Phase 2 is currently open for enrollment. Participant eligibility and participating clinical centers information is available on clinicaltrials.gov under identifier NCT04150497.

Cellectis is a clinical-stage biotechnology company using gene editing technology to develop cell and gene therapies. The information is based on a company press release statement.