# Cellectis Receives FDA RMAT Designation for lasme-cel, the First Allogeneic CAR-T Therapy in a Pivotal Trial for Patients with r/r B-ALL
Canonical URL: https://biopharmsignal.com/news/CLLS/cellectis-receives-fda-rmat-designation-for-lasme-cel-the-first-allogeneic-car-t-629c5c17
Ticker: CLLS
Company: Cellectis
Source: Cellectis
Published: 2026-06-09 20:30 EST
Original Source URL: https://www.cellectis.com/en/press/cellectis-receives-fda-rmat-designation-for-lasme-cel-the-first-allogeneic-car-t-therapy-in-a-pivotal-trial-for-patients-with-r-r-b-all/
## Summary

New York, NY - June 9, 2026 - Cellectis (the "Company") (Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene editing platform to develop life-saving cell and gene therapies, today announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to lasmecabtagene timgedleucel (lasme-cel), its CD22-targeting allogeneic CAR-T cell therapy product candidate, for the treatment of patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).

The granting of RMAT designation reflects the FDA's recognition of the potential for lasme-cel to address the unmet medical need faced by patients with r/r B-ALL.

The RMAT designation is supported by Phase 1 BALLI-01 data demonstrating promising efficacy and a manageable safety profile. Final Phase 1 data from the BALLI-01 trial of lasme-cel will be presented in an oral session at the 2026 Congress of the European Hematology Association (EHA) this Saturday, June 13 at 5:15 - 6:30pm CET by Nitin Jain, M.D., Professor of Medicine, Department of Leukemia at MD Anderson Cancer Center in Houston (TX).

"As the company that pioneered allogeneic CAR-T, we see the RMAT designation for lasme-cel as a meaningful recognition of the need for off-the-shelf CAR-T options for patients with relapsed or refractory B-ALL, patients who cannot wait. This designation strengthens our dialogue with the FDA as we advance lasme-cel through its pivotal program" said André Choulika, Ph.D., Co-founder and Chief Executive Officer of Cellectis.

The BALLI-01 trial Pivotal Phase 2 is open for enrollment. Information on participant eligibility and participating clinical centers can be found on clinicaltrials.gov: BALLI-01 (NCT04150497).

## Article Body
New York, NY - June 9, 2026 - Cellectis (the "Company") (Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene editing platform to develop life-saving cell and gene therapies, today announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to lasmecabtagene timgedleucel (lasme-cel), its CD22-targeting allogeneic CAR-T cell therapy product candidate, for the treatment of patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).

The granting of RMAT designation reflects the FDA's recognition of the potential for lasme-cel to address the unmet medical need faced by patients with r/r B-ALL.

The RMAT designation is supported by Phase 1 BALLI-01 data demonstrating promising efficacy and a manageable safety profile. Final Phase 1 data from the BALLI-01 trial of lasme-cel will be presented in an oral session at the 2026 Congress of the European Hematology Association (EHA) this Saturday, June 13 at 5:15 - 6:30pm CET by Nitin Jain, M.D., Professor of Medicine, Department of Leukemia at MD Anderson Cancer Center in Houston (TX).

"As the company that pioneered allogeneic CAR-T, we see the RMAT designation for lasme-cel as a meaningful recognition of the need for off-the-shelf CAR-T options for patients with relapsed or refractory B-ALL, patients who cannot wait. This designation strengthens our dialogue with the FDA as we advance lasme-cel through its pivotal program" said André Choulika, Ph.D., Co-founder and Chief Executive Officer of Cellectis.

The BALLI-01 trial Pivotal Phase 2 is open for enrollment. Information on participant eligibility and participating clinical centers can be found on clinicaltrials.gov: BALLI-01 (NCT04150497).
## Recent Company News
- 2026-06-25 20:30 EST — [Cellectis Reports Results from Shareholders Meeting Held on June 25, 2026](https://biopharmsignal.com/news/CLLS/cellectis-reports-results-from-shareholders-meeting-held-on-june-25-2026-28c487bb) — Source: Cellectis
- 2026-06-11 06:40 EST — [Cellectis Presents Final Phase 1 Results of Lasme-cel and  Preliminary Results on Eti-cel at EHA 2026 Congress](https://biopharmsignal.com/news/CLLS/cellectis-presents-final-phase-1-results-of-lasme-cel-and-preliminary-results-on-ea9f9ebc) — Source: Cellectis
- 2026-06-09 20:30 EST — [Cellectis Receives FDA RMAT Designation for lasme-cel, the First Allogeneic CAR-T Therapy in a Pivotal Trial for Patients with r/r B-ALL](https://biopharmsignal.com/news/CLLS/cellectis-receives-fda-rmat-designation-for-lasme-cel-the-first-allogeneic-car-t-629c5c17) — Source: Cellectis
- 2026-05-20 20:30 EST — [Cellectis’ Annual Shareholders General Meeting to be Held on June 25, 2026](https://biopharmsignal.com/news/CLLS/cellectis-annual-shareholders-general-meeting-to-be-held-on-june-25-2026) — Source: Cellectis
- 2026-05-12 13:30 EST — [Cellectis to Present Clinical Data on Lasme-cel and Eti-cel at EHA 2026 Annual Congress](https://biopharmsignal.com/news/CLLS/cellectis-to-present-clinical-data-on-lasme-cel-and-eti-cel-at-eha-2026-annual-congress) — Source: Cellectis
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