Phase I Study of MB-CART19.1 Cellular Therapy for Relapsed or Refractory Primary and Secondary Central Nervous System Lymphoma Using On-Site Manufacturing

What this Trial Is About

Researchers are evaluating MB-CART19.1 cellular therapy as a treatment for central nervous system lymphoma CNSL, including both primary and secondary types. This phase I study aims to determine the highest dose of MB-CART19.1 that causes only mild or few side effects, focusing on safety and effectiveness in patients with relapsed or refractory CNSL. Participants will undergo a process called leukapheresis to collect specific immune cells from their blood. These cells are then modified in the laboratory using a lentiviral vector to target CD19, a marker on lymphoma cells. The modified T cells are expanded and infused back into the patient 2 to 7 days after chemotherapy that prepares the body. The infusion may be fresh or frozen based on standard procedures. After treatment, blood and cerebrospinal fluid samples will be collected to monitor treatment effects, toxicity, and the survival of the modified cells. During the study, participants will have regular assessments including imaging scans such as MRI or CT to check disease status, blood tests to evaluate organ function, and cerebrospinal fluid analysis. Researchers will monitor safety by tracking side effects and will measure the maximum tolerated dose over one year. The entire study period covers treatment administration and follow-up to understand how well the therapy works and its safety profile.

A Study of MB-CART19.1 Cellular Therapy for People With Central Nervous System Lymphoma (CNSL)