R&D Day 2025
Logotype for Cellectis S.A.

Cellectis (ALCLS) R&D Day 2025 summary

Event summary combining transcript, slides, and related documents.

Logotype for Cellectis S.A.

R&D Day 2025 summary

3 Feb, 2026

Pipeline overview and program updates

  • UCART22 (lasme-cel), an allogeneic off-the-shelf CAR-T targeting CD22, is advancing to a pivotal phase II trial for relapsed/refractory B-ALL, with first patient enrollment expected by year-end and a focus on patients aged 12–50 years.

  • Eti-cel (UCART20x22) for r/r NHL showed an 86% ORR and 57% CR rate in preliminary data, with further updates expected by end of 2025.

  • Internalized manufacturing enables scalable, high-quality, and cost-controlled production, with capacity expansion planned to meet global demand and support AstraZeneca collaborations.

  • Additional programs include Epicel (dual CD20/CD22 targeting) and preclinical in vivo gene therapy, with key data readouts expected by 2026.

Clinical trial data and development milestones

  • Phase I/II data for UCART22/lasme-cel show high response rates in heavily pretreated B-ALL patients, with 100% response and high MRD negativity in the phase II target population; median OS for MRD-negative responders reached 14.8 months.

  • Safety profile is favorable, with low rates of severe CRS, ICANS, and GvHD, and manageable toxicity.

  • Most eligible patients proceeded to transplant, supporting the therapy as a bridge to HSCT.

  • Pivotal phase II is designed as a registrational trial, with BLA submission targeted for 2028.

R&D strategy and innovation priorities

  • Emphasis on allogeneic, off-the-shelf CAR-T therapies for scalability, standardization, and rapid patient access.

  • Strategic focus on internal manufacturing, process optimization, and expansion into in vivo gene editing and dual-targeting constructs.

  • Achieving MRD-negative remission to enable stem cell transplantation and improve survival.

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