Study of Radiation Therapy Before CAR T-Cell Treatment for Relapsed or Refractory Large B-Cell Lymphoma

What this Trial Is About

Researchers are evaluating the use of bridging radiation therapy given before chimeric antigen receptor CAR T-cell infusion to treat large B-cell lymphoma LBCL that has returned or not responded to prior treatments. This early phase I trial focuses on patients with relapsed or refractory LBCL, a group with historically poor outlooks. CAR T-cell therapy involves modifying a patients immune cells to target and attack cancer cells, but during the time between cell collection and infusion, disease symptoms may worsen. Bridging radiation aims to control disease and symptoms during this critical period before CAR T-cell infusion. Participants undergo leukapheresis to collect T-cells, followed by external beam radiation therapy to all sites of active disease identified by PET scans. After radiation, patients receive commercial CAR T-cell infusion as standard care. Imaging with PETCT and possibly MRI is done throughout the study to monitor disease. Blood samples are collected multiple times for immune profiling and other analyses. The study uses the RefleXion X1 linear accelerator for radiation and tracks responses and side effects. During the study, patients have regular scans and blood tests to assess disease control, treatment response, and side effects up to one year after CAR T-cell infusion. Researchers measure how many complete the planned radiation therapy and evaluate outcomes like progression-free survival, overall survival, and local and distant disease control. The study involves about 3 months of treatment preparation and follows patients for safety and treatment effectiveness for up to one year.

Evaluation of Bridging Radiation Therapy Before CAR T-Cell Infusion for the Treatment of Relapsed or Refractory Large B-Cell Lymphoma