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Cellectis Says US FDA Granted RMAT Designation to Lasme-cel to Treat r/r B-ALL Patients

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Cellectis (CLLS) said Tuesday the US Food and Drug Administration has given the Regenerative Medicine Advanced Therapy, or RMAT, designation to lasme-cel to treat relapsed or refractory B-cell acute lymphoblastic leukemia.

The designation is backed by phase 1 results showing "promising efficacy and a manageable safety profile," the company said.

Final phase 1 data from the trial will be presented in a session at the 2026 Congress of the European Hematology Association on June 13, Cellectis said.

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