Phase 1 Study Evaluating CARv3-TEAM-E T Cells Delivered via Ommaya Reservoir for Recurrent or Newly Diagnosed Glioblastoma with EGFRvIII Mutation

What this Trial Is About

Researchers are studying CARv3-TEAM-E T Cells as a treatment for participants with recurrent or newly diagnosed glioblastoma, a type of brain cancer. This Phase 1 study aims to find the best dose and to evaluate the safety of this treatment, which uses a persons own genetically modified immune cells to target cancer cells. This is the first time CARv3-TEAM-E T Cells will be given to humans, and the study is funded by an internal grant program. Participants will undergo a process where their immune cells are collected and genetically altered to create CARv3-TEAM-E T Cells. Before receiving the cells, participants will have lymphodepletion chemotherapy and a dose of rituximab. The modified cells will then be infused through an Ommaya reservoir, a device implanted to deliver treatment directly to the brain. Participants may receive one infusion initially and, if they benefit and have enough product available, they can receive up to five additional doses. The study includes a safety run-in phase and specific groups based on glioblastoma type and mutation status. Throughout the study, participants will have screenings, treatment, and follow-up visits for up to two years after therapy to monitor safety and response. These visits include blood tests, echocardiograms, and imaging scans of tumors. Researchers will track side effects, dose-limiting toxicities, and treatment responses using MRI and other assessments. Long-term monitoring may continue for up to 15 years to evaluate the lasting effects and safety of the treatment.

CARv3-TEAM-E T Cells in Glioblastoma