Cellectis’ lasme-cel Gains FDA RMAT Designation with Phase 2 r/r B-ALL Trial Now Enrolling
CLLS•Cellectis’ allogeneic CAR-T candidate lasme-cel received FDA RMAT designation for relapsed/refractory B-ALL based on Phase 1 BALLI-01 efficacy and safety data. The pivotal Phase 2 BALLI-01 trial is now open for enrollment, with final Phase 1 results due June 13 at the European Hematology Association Congress.
1. FDA Grants RMAT Designation to lasme-cel
The FDA granted Regenerative Medicine Advanced Therapy designation to lasme-cel for relapsed/refractory B-cell acute lymphoblastic leukemia, marking the first allogeneic CAR-T therapy in a pivotal trial to earn this status. This recognition highlights the therapy’s potential to address a critical unmet need in r/r B-ALL.
2. Support from Phase 1 BALLI-01 Data
Phase 1 BALLI-01 interim results demonstrated promising anti-leukemia activity and a manageable safety profile in patients with r/r B-ALL, underpinning the RMAT designation. These findings reinforce confidence in lasme-cel’s advancement toward a registrational Phase 2 program.
3. Pivotal Phase 2 Trial Underway
The BALLI-01 pivotal Phase 2 trial is now enrolling patients with relapsed/refractory B-ALL at multiple global centers. Eligibility criteria and site details are publicly available on clinicaltrials.gov under identifier NCT04150497.
4. Upcoming EHA 2026 Data Presentation
Final Phase 1 BALLI-01 data will be presented in an oral session on June 13 at the European Hematology Association Congress, covering detailed efficacy outcomes and safety observations. This presentation will offer deeper insight into lasme-cel’s clinical profile.
