Comparing Immunotherapy Bridging and Maintenance Therapy to No Bridging in CAR-T Treatment for Low-risk Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

What this Trial Is About

This research aims to find out if adding immunotherapy as a bridging treatment before CAR-T therapy can improve results for patients with low-risk relapsed or refractory B-cell non-Hodgkin lymphoma B-NHL. The study compares immunotherapy bridging treatment against no bridging treatment to identify the best approach for low-risk patients. It is a Phase 2, multicenter, randomized, open-label clinical trial sponsored by Ruijin Hospital. Participants in the immunotherapy bridging group will receive zanubrutinib, with or without radiotherapy depending on lesion suitability, before CAR-T therapy. The group without bridging treatment will not receive these medications. After 28 days, patients who show a complete response will not have maintenance therapy, while those with a partial response will receive oral zanubrutinib plus a PD-1 inhibitor for two years. Patients with stable or progressive disease are not included in the study. During the trial, participants will be monitored at 28 days and three months after CAR-T infusion to assess response rates. Researchers will also follow patients for two years to evaluate survival, disease progression, CAR-T cell levels, and side effects. Assessments include physical exams, laboratory tests, and imaging to track treatment effects and safety. This detailed follow-up helps determine the most effective treatment plan for low-risk B-NHL patients.

Immunobridging/Maintenance Therapy Versus Non-bridging Therapy in CAR-T Therapy for Low-risk R/R B-NHL