Cellectis SA ((CMVLF)) announced an update on their ongoing clinical study.
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Study Overview: The clinical study titled Open-label Dose-finding and Dose-expansion Study to Evaluate the Safety, Expansion, Persistence, and Clinical Activity of UCART20x22 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (B-NHL) aims to assess the safety and clinical effectiveness of UCART20x22. This study is significant as it seeks to determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) for patients with relapsed or refractory B-NHL, a challenging condition to treat.
Intervention/Treatment: The study tests UCART20x22, an allogeneic engineered T-cell therapy expressing anti-CD20 and anti-CD22 Chimeric Antigen Receptors, designed to target and destroy cancerous B-cells. It is administered following a lymphodepletion regimen, with CLLS52, a monoclonal antibody recognizing CD52 antigen, also being evaluated.
Study Design: This is an interventional study with a single-group assignment. There is no allocation or masking involved, and the primary purpose is treatment. The study is structured in two parts: dose finding to identify MTD and RP2D, followed by dose expansion at the RP2D.
Study Timeline: The study commenced on October 25, 2022. The primary completion and estimated study completion dates are yet to be disclosed, but the latest update was submitted on August 19, 2025. These dates are crucial for tracking the study’s progress and potential market entry.
Market Implications: The ongoing study by Cellectis S.A. could significantly influence its stock performance and investor sentiment, especially if UCART20x22 demonstrates positive results. As a first-in-human study, successful outcomes could position Cellectis as a leader in innovative cancer therapies, potentially impacting competitors in the oncology sector.
The study is currently recruiting, with further details available on the ClinicalTrials portal.