Cellectis: 100% Response Rate for its CAR-T Therapy Against Leukemia
Cellectis, a clinical-stage biotechnology company, presents its 2025 results and an update on its development activities. The company announces the progress of its allogeneic CAR-T therapy programs and details its clinical trial schedule for 2026.
Continued Development in CAR-T Therapies
Cellectis continues the development of its portfolio of allogeneic CAR-T therapies. Lasmé-cel, evaluated in relapsed or refractory acute B-cell lymphoblastic leukemia (B-ALL) through the BALLI-01 study, recorded a 100% overall response rate in the phase 2 target population. All patients in this target group became eligible for a transplant. An interim analysis of the pivotal phase 2 is expected in the fourth quarter of 2026, with a marketing authorization application planned for 2028. Éti-cel, evaluated in relapsed or refractory non-Hodgkin lymphoma (NHL), shows at the current dose level an overall response rate of 88% and a complete response rate of 63%. Cellectis is currently recruiting an additional cohort with low-dose interleukin-2 administration, aiming to assess the improvement in response durability. All phase 1 data is expected in the fourth quarter of 2026. In terms of technological platform, Cellectis published in November 2025 in Nature Communications an article establishing circular single-stranded DNA (cssDNA) as an effective non-viral matrix for gene insertion into hematopoietic stem cells. Cellectis also presented safety results regarding TALE base editors (TALEB), which allow precise DNA editing without causing double-strand breaks.
Development Through Major Partnership Agreements
Cellectis continues its development through two major partnership agreements. With AstraZeneca, activities are progressing in accordance with the research and collaboration agreement on the development of up to 10 new cell and gene therapy products in oncology, immunology, and rare genetic diseases. With Servier (via its sublicensee Allogene), a randomized phase 2 pivotal trial (ALPHA3) is evaluating cema-cel as a first-line consolidation treatment in diffuse large B-cell lymphoma. An interim futility analysis is scheduled for April 2026. As of December 31, 2025, Cellectis had $211 million in cash, cash equivalents, and term deposits. The company estimates that these resources will be sufficient to fund its activities until the second half of 2027. The cash will be focused on supporting the development of the product candidate portfolio, including manufacturing and clinical development expenses related to lasmé-cel, éti-cel, and new potential candidates.
