Phase II Multi-Center Study of MB-CART2019.1 CAR T Cell Therapy for Adults With Relapsed or Refractory Diffuse Large B Cell Lymphoma

What this Trial Is About

Researchers are studying a treatment for patients with relapsed or refractory diffuse large B cell lymphoma DLBCL who have already received at least two lines of therapy. This phase II, multi-center, single arm trial is evaluating the safety, effectiveness, and how the body processes a new therapy called MB-CART2019.1, which uses specially engineered T cells targeting CD19 and CD20 proteins on lymphoma cells. Participants will have their own immune cells collected through leukapheresis, which are then modified in the lab to target cancer cells. Before receiving the treatment, they undergo chemotherapy with cyclophosphamide and fludarabine to prepare their body. The modified cells are infused intravenously at a dose based on body weight. After treatment, participants are followed for up to two years to monitor treatment response, side effects, and quality of life. Additional long-term follow-up may occur under a separate protocol. During the study, participants will have regular assessments including scans, laboratory tests, and quality of life questionnaires. Researchers will track response to treatment at 1 month and ongoing outcomes such as survival and side effects for up to two years. They will also monitor immune responses, levels of the infused cells, and other biological markers. This comprehensive monitoring aims to provide detailed information about the therapys impact and safety throughout the study period.

DALY II Japan/MB-CART2019.1 for DLBCL