Phase 1 Study of CD79b-19 CAR T Cell Therapy for Adults with Relapsed or Refractory Non-Hodgkin Lymphoma

What this Trial Is About

Researchers are evaluating CD79b-19 CAR T cells as a treatment for people with relapsed or refractory Non-Hodgkin Lymphoma. This Phase 1 study aims to assess the safety and side effects of this investigational therapy, which uses the patients own immune cells to target cancer. The study includes patients with various subtypes of Non-Hodgkin Lymphoma who have previously undergone multiple treatments. The research is conducted in two parts dose escalation to find the safe maximum dose and dose expansion to treat more participants at that dose. Participants will undergo leukapheresis to collect white blood cells about three weeks before treatment. They will then receive chemotherapy with fludarabine and cyclophosphamide for three days to prepare their body for the CAR T cell infusion. On day 0, participants receive a single intravenous infusion of CD79b-19 CAR T cells, with the dose depending on earlier participant tolerability. The infusion lasts about one hour. After treatment, participants will be monitored regularly for up to two years. During the study, participants will have evaluations and follow-up visits to assess their health and response to treatment. Researchers will monitor for adverse events and dose-limiting toxicities over the two-year period. They will also track outcomes such as overall response, survival, and progression-free survival at multiple intervals. Participants must meet specific health and laboratory criteria to join and will be closely observed for safety and treatment effects throughout the study.

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma