Phase 1 Study of BAFFR-Targeting CAR T-Cell Therapy with Chemotherapy for Relapsed or Refractory B-Cell Blood Cancers

What this Trial Is About

Researchers are evaluating the safety, side effects, and best dose of a new treatment called BAFFR-based chimeric antigen receptor CAR T-cells combined with chemotherapy drugs fludarabine and cyclophosphamide for patients with B-cell blood cancers that have returned or are resistant to treatment. This phase I trial aims to find the recommended doses and assess the treatments effectiveness and long-term effects in patients with these difficult-to-treat cancers. The study also explores how the treatment interacts with the cancer cells at the molecular level. Participants first undergo a process called leukapheresis to collect their T cells. They then receive chemotherapy with cyclophosphamide and fludarabine or bendamustine to prepare the body. On day 0, patients receive an infusion of their modified BAFFR-targeting CAR T-cells. Various imaging tests like echocardiography, MRI, CT, and PET scans, as well as bone marrow biopsies and blood samples, are taken before and during the study to monitor disease and treatment effects. After receiving treatment, patients are closely followed up on multiple days within the first month and then periodically for up to 15 years to monitor safety and treatment outcomes. Researchers measure dose-related toxicities, adverse events, response rates, survival, and long-term side effects. The study includes detailed assessments to understand treatment behavior and cancer response, ensuring ongoing safety and effectiveness evaluation over many years.

B-Cell Activating Factor Receptor (BAFFR)-Based Chimeric Antigen Receptor T-Cells With Fludarabine and Cyclophosphamide Lymphodepletion for the Treatment of Relapsed or Refractory B-cell Hematologic Malignancies