Cellectis S.A. (CLLS), a clinical-stage biotechnology company, announced that the U.S. Food and Drug Administration, or FDA, has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to its CAR-T cell therapy candidate Lasmecabtagene timgedleucel, also known as "lasme-cel," for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). B-cell acute lymphoblastic leukemia (B-ALL) is a type of blood cancer caused by the uncontrolled proliferation of immature B-cell lymphoblasts. When lymphoblastic leukemia cells fail to respond to treatment and do not achieve remission, it leads to relapsed or refractory B-ALL. (Source: clevelandclinic)
Lasmecabtagene timgedleucel, or lasme-cel, is an allogeneic CAR-T cell product that targets CD-22 and is currently being evaluated for r/r B-ALL treatment in Cellectis' pivotal phase 2 trial dubbed BALLI-01. The first interim results of the phase 2 trial are expected in the fourth quarter of 2026.
The RMAT designation is supported by encouraging results from Phase 1, dubbed BALLI-01 data, that demonstrated a manageable safety profile and promising efficacy. Additionally, the company noted it will present the final phase 1 data from BALLI-01 of lasme-cel at the Congress of the European Hematology Association (EHA) held on June 13, 2026.
Cellectis has traded between $1.3270 and $5.4800 over the last year.
Cellectis shares closed Tuesday at $2.99, up 2.05%. In the overnight market the shares are trading at $3.08, up 3.01%.
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