Phase II Study of MB-CART2019.1 CAR-T Cell Therapy Targeting CD19 and CD20 for Adults With Relapsed or Refractory Diffuse Large B-Cell and Other B-Cell Lymphomas

What this Trial Is About

Researchers are evaluating the safety, effectiveness, and behavior in the body of zamtocabtagene autoleucel MB-CART2019.1, a genetically engineered T cell therapy targeting CD19 and CD20, in patients with various forms of relapsed or refractory B cell lymphoma. This phase II, multi-center, single-arm study includes participants with diffuse large B-cell lymphoma DLBCL who have received at least two prior treatments, as well as those with primary or secondary central nervous system lymphoma, mantle cell lymphoma, Richters transformation, and transplant-ineligible DLBCL after first-line therapy. The study aims to understand how this therapy works in these difficult-to-treat lymphoma cases. Participants will first undergo leukapheresis to collect their immune cells, which are then modified to create MB-CART2019.1. Before receiving the cell infusion, they will have a lymphodepleting chemotherapy regimen using cyclophosphamide and fludarabine, or bendamustine. The cell therapy is given intravenously at a dose based on body weight. The study begins with a safety evaluation phase enrolling three subjects, followed by further enrollment once safety is established. Participants will be followed for up to two years to assess treatment effects and quality of life, with potential additional long-term follow-up under a separate protocol. During the study, participants will be closely monitored with scans, biopsies, and laboratory tests to measure response rates, survival, adverse events, immune responses, and quality of life. Assessments include imaging like PETCT and MRI, blood tests for immune markers and drug levels, and patient questionnaires. Safety and effectiveness outcomes will be tracked throughout the two-year follow-up period to provide a comprehensive picture of the therapys impact and durability in this patient population.

DALY II USA/ MB-CART2019.1 for DLBCL