Cellectis says FDA grants RMAT status to lasme-cel in pivotal BALLI-01 trial for relapsed/refractory B-cell ALL

PUBT · 06/09 23:12
Cellectis says FDA grants RMAT status to lasme-cel in pivotal BALLI-01 trial for relapsed/refractory B-cell ALL
- Cellectis received FDA RMAT designation for lasme-cel, an off-the-shelf CD22 CAR-T, supporting its pivotal Phase 2 BALLI-01 program in relapsed or refractory B-cell ALL.
- The designation follows Phase 1 BALLI-01 results that showed encouraging activity with a manageable safety profile, without disclosing detailed metrics.
- Final Phase 1 results will be presented on June 13 at the 2026 European Hematology Association congress.
- The pivotal Phase 2 study is open for enrollment, positioning lasme-cel as a potential accelerated regulatory candidate in a high-need leukemia setting.
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