# 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-therapy-in-a-pivotal-trial-for-patients-with-r-r-b-all Ticker: CLLS Company: Cellectis Source: Cellectis Published: 2026-06-25 13:46 EST Original Source URL: https://www.cellectis.com ## Summary

New York, NY – June 9, 2026 - Cellectis (the “Company”) (Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company usi ## 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 - 2026-06-25 13:46 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-eti-cel-at-eha-2026-congress) — Source: Cellectis - 2026-06-25 13:46 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-therapy-in-a-pivotal-trial-for-patients-with-r-r-b-all) — Source: Cellectis - 2026-06-25 13:46 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 - 2026-06-25 13:46 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 ## Related News - 2026-07-21 12:00 EST — MOR — [Novartis delivered sales growth in Q2 and further advanced the pipeline; Full-year guidance reaffirmed](https://biopharmsignal.com/news/MOR/novartis-delivered-sales-growth-in-q2-and-further-advanced-the-pipeline-full-yea-63a32b47) - 2026-07-21 10:28 EST — GSK — [ViiV Healthcare to present phase IIIb data comparing Dovato with Biktarvy in treatment-naïve adults alongside INSTI-powered long-acting injectable innovation at AIDS 2026](https://biopharmsignal.com/news/GSK/viiv-healthcare-to-present-phase-iiib-data-comparing-dovato-with-biktarvy-in-tre-1ff3f640) - 2026-07-20 20:05 EST — RANI — [Rani Therapeutics Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)](https://biopharmsignal.com/news/RANI/rani-therapeutics-reports-inducement-grant-under-nasdaq-listing-rule-5635-c-4-ec56b3b0) - 2026-07-20 14:53 EST — IPHA — [Innate Pharma announces Completion of Enrollment in Phase 1 Dose Escalation Study of IPH4502, a Novel Nectin-4 Exatecan Antibody-Drug Conjugate (ADC)](https://biopharmsignal.com/news/IPHA/innate-pharma-announces-completion-of-enrollment-in-phase-1-dose-escalation-stud-0778493f) - 2026-07-20 13:05 EST — ACAD — [Acadia Pharmaceuticals Receives FDA Fast Track Designation for Remlifanserin in Alzheimer's Disease Psychosis](https://biopharmsignal.com/news/ACAD/acadia-pharmaceuticals-receives-fda-fast-track-designation-for-remlifanserin-in--f36b622c)