Phase II Study Comparing MB-CART2019.1 CAR T-cell Therapy to Standard Treatments in Adults with Relapsed or Refractory Diffuse Large B-cell Lymphoma Not Eligible for High-Dose Chemotherapy and Stem Cell Transplant

What this Trial Is About

Researchers are evaluating the effectiveness and safety of MB-CART2019.1 compared to standard treatments in adults with relapsed or refractory diffuse large B-cell lymphoma DLBCL who are not eligible for intensive chemotherapy and stem cell transplantation. The study is a pivotal Phase II randomized, multi-center, open-label trial with two parts Part I compares MB-CART2019.1 to standard therapy, while Part II evaluates MB-CART2019.1 alone in younger, fitter patients. MB-CART2019.1 is a genetically modified T-cell therapy designed to target malignant B cells in advanced blood cancers. Participants in Part I are randomly assigned to receive either a single infusion of MB-CART2019.1 following lymphodepleting chemotherapy or standard of care SoC therapy, which includes regimens like R-GemOx or BR plus polatuzumab vedotin. Patients undergo leukapheresis to collect T cells for MB-CART2019.1 production. Those in the SoC arm may later receive MB-CART2019.1 if certain disease progression criteria are met. Part II will enroll younger participants to receive MB-CART2019.1 alone after Part I enrollment completes. Participants will be involved in screening, treatment, and follow-up visits totaling about 55 weeks. Assessments include scans, laboratory tests, and evaluations of disease response and safety. Primary outcomes measure event-free survival in Part I and objective response rate in Part II, both up to 30 weeks after treatment. Secondary outcomes include progression-free survival, overall survival, and duration of response assessed up to nearly two years. Extended long-term follow-up beyond the active study period will be reported separately.

Efficacy and Safety of MB-CART2019.1 vs. SoC in Lymphoma Patients