# FDA Grants Orphan Drug Designation to Cellectis’ CLLS52 (alemtuzumab) For ALL Treatment Canonical URL: https://biopharmsignal.com/news/CLLS/fda-grants-orphan-drug-designation-to-cellectis-clls52-alemtuzumab-for-all-treatment Ticker: CLLS Company: Cellectis Source: Cellectis Published: 2024-08-01 20:30 EST Original Source URL: https://www.cellectis.com ## Summary

New York, NY – August 1, 2024 – Cellectis (the “Company”) (Euronext Growth: AL ## Article Body New York, NY - August 1, 2024 - 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) has granted Orphan Drug Designation (ODD) to Cellectis' CLLS52 (alemtuzumab), an Investigational Medicinal Product (IMP) used as part of the lymphodepletion regimen associated with UCART22, evaluated in the BALLI-01 clinical trial in relapsed/refractory B-cell acute lymphoblastic leukemia (ALL). "We are excited that the FDA granted CLLS52 (alemtuzumab) ODD designation status. The importance of adding alemtuzumab to the lymphodepletion regimen has been demonstrated in Cellectis' BALLI-01 study, where the addition of this lymphodepletion agent to the fludarabine and cyclophosphamide regimen was associated with sustained lymphodepletion and significantly higher UCART22 cell expansion allowing for greater clinical activity", said Mark Frattini, M.D., Ph.D. Chief Medical Officer at Cellectis. Cellectis is the inventor of the combination of CD52 knockout UCART cells with a lymphodepleting regimen containing an anti-CD52 antibody such as alemtuzumab. The CD52 knockout aims to render the UCART product candidates resistant to alemtuzumab as part of the lymphodepleting regimen. Cellectis' UCART22 product candidate has the CD52 gene inactivated by TALEN® gene editing technology. The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US. Receiving ODD may help to expedite and reduce the cost of development, approval, and commercialization of a therapeutic agent. ## 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 ## Related News - 2026-07-29 14:05 EST — CAPR — [The Lancet Publishes HOPE-3 Data for Capricor Therapeutics’ Deramiocel in Duchenne Muscular Dystrophy](https://biopharmsignal.com/news/CAPR/the-lancet-publishes-hope-3-data-for-capricor-therapeutics-deramiocel-in-duchenn-9e6e6bd9) - 2026-07-29 13:00 EST — ENLV — [Enlivex Management to Host Webinar to Discuss Capital Strategy, Rain Protocol Treasury Strategy, and Recent Clinical Milestones](https://biopharmsignal.com/news/ENLV/enlivex-management-to-host-webinar-to-discuss-capital-strategy-rain-protocol-tre-5921a627) - 2026-07-29 12:30 EST — PRGO — [Perrigo to Present at the Canaccord 46th Annual Growth Conference](https://biopharmsignal.com/news/PRGO/perrigo-to-present-at-the-canaccord-46th-annual-growth-conference-40431922) - 2026-07-29 12:30 EST — LIXT — [NOMAD Announces Operational Deployment of Two Mobile Battery Systems by DSO Electric Cooperative](https://biopharmsignal.com/news/LIXT/nomad-announces-operational-deployment-of-two-mobile-battery-systems-by-dso-elec-7fc12a2c) - 2026-07-29 12:30 EST — RNXT — [RenovoRx to Host Second Quarter 2026 Financial Results and Business Highlights Conference Call on August 12th at 4:30 p.m. ET](https://biopharmsignal.com/news/RNXT/renovorx-to-host-second-quarter-2026-financial-results-and-business-highlights-c-8bed10ec)