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Cellectis wins FDA RMAT status for lasme-cel in pivotal BALLI-01 trial for relapsed/refractory B-cell ALL
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Cellectis wins FDA RMAT status for lasme-cel in pivotal BALLI-01 trial for relapsed/refractory B-cell ALL
  • Cellectis won FDA RMAT designation for lasmé-cel, an off-the-shelf CD22 CAR-T program in a pivotal trial for relapsed or refractory B-cell ALL.
  • The designation was supported by Phase 1 BALLI-01 data showing encouraging activity with a manageable safety profile, without disclosing detailed efficacy metrics.
  • Final Phase 1 results are scheduled for oral presentation on June 13 at the 2026 European Hematology Association congress.
  • The Phase 2 pivotal BALLI-01 study is open for enrollment, supporting the company’s push toward a potential registration pathway.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Cellectis SA published the original content used to generate this news brief on June 09, 2026, and is solely responsible for the information contained therein.

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