Phase 2 Study Evaluating Safety and Effectiveness of WZTL-002 CAR T-cell Therapy in Adults With Relapsed or Refractory Large B-cell Lymphoma

What this Trial Is About

Researchers are studying a new type of chimeric antigen receptor CAR T-cell therapy called atlacabtagene autoleucel WZTL-002 for adults with large B-cell lymphomas LBCL that have not responded to or have returned after standard chemotherapy. This phase 2 trial aims to evaluate the treatments effectiveness and safety, focusing on the complete response rate of lymphoma and the risk of neurotoxicity. Approximately 60 participants with relapsed or refractory LBCL will be enrolled and treated in this single-arm study. Participants will undergo a procedure called leukapheresis to collect their white blood cells, which are then modified to create the WZTL-002 CAR T-cells. Before receiving the CAR T-cells, participants will get chemotherapy with fludarabine and cyclophosphamide to prepare their bodies. The treatment involves a single infusion of WZTL-002 given intravenously. After infusion, participants will be closely monitored for 14 days for side effects such as cytokine release syndrome and neurotoxicity. Scans will be done at screening and at several points up to 24 months after treatment to check the response and duration of effect. During the study, participants will have PETCT and CT scans to assess treatment response and follow-up evaluations to measure treatment impact. Blood samples will be collected to study the behavior of the CAR T-cells and the effect on B-cells. The study includes safety monitoring for adverse effects and quality of life assessments up to 24 months after treatment. Long-term follow-up will continue through specialized registries beyond the main study period. The total participation duration may extend up to five years, with detailed monitoring especially in the first two years after treatment.

A Study of Atlacabtagene Autoleucel CAR T-cells for Adults With Relapsed Large B-cell Lymphoma