Phase 1 Study of Personalized E-SYNC CAR T Cell Therapy in Adults with EGFRvIII Glioblastoma Testing Safety and Best Dose After Chemotherapy and Radiation

What this Trial Is About

Researchers are evaluating the safety, side effects, and best dose of a new treatment called E-SYNC chimeric antigen receptor CAR T cells for adults with EGFRvIII positive glioblastoma, a type of brain cancer. This phase I trial aims to understand how these specially modified immune cells work after patients receive lymphodepleting chemotherapy. The study also looks at how feasible it is to produce and give these cells, their effects on tumor tissue and blood, and explores immune responses and survival following treatment. Participants are divided into two groups Cohort 1 includes newly diagnosed patients who have completed radiation therapy, and Cohort 2 includes patients with recurrent glioblastoma who need surgery. Both groups undergo a process called leukapheresis to collect immune cells, followed by chemotherapy with cyclophosphamide and fludarabine given intravenously on days -5, -4, and -3. On day 0, participants receive an infusion of E-SYNC T cells at different dose levels depending on the cohort. Cohort 2 participants also undergo surgical tumor removal between days 14 and 28 after treatment. During the study, participants are closely monitored with scheduled follow-ups ranging from days 1 to 28 after infusion, then at increasing intervals up to 15 years. Researchers assess safety by tracking adverse events, monitor the presence and activation of the CAR T cells in blood and tumor tissue, and evaluate anti-tumor responses. The long-term follow-up includes regular visits and testing to understand the treatments effects over time and support participant health.

Anti-EGFRvIII synNotch Receptor Induced Anti-EphA2/IL-13Ralpha2 CAR (E-SYNC) T Cells