This is a single site, non-randomized, open-label, long-term safety and efficacy follow-up Phase 1 study for subjects who have been treated with CARv3-TEAM-E T cells in clinical Study DF/HCC IRB #20-532 (the main study), that evaluated the safety and efficacy of CARv3-TEAM-E T cells in subjects with newly diagnosed or recurrent glioblastoma.~CARv3-TEAM-E drug product is defined as autologous T lymphocytes transduced with a CAR lentiviral vector encoding a chimeric antigen receptor targeting human EGFRvIII antigen and a T cell engaging antibody molecule (TEAM) targeting wildtype EGFR. CARv3-TEAM-E T cells are administered in subjects up to six times in main Study #20-532.~No investigational treatment will be administered in this study.~The United States Food and Drug Administration (FDA, 2018) recommend long-term follow-up for subjects treated with gene therapy drug products to monitor for selected adverse events (AEs) and the durability of clinical response.~After the subjects in the parent study has been completed (24 months after CARv3-TEAM-E T cells infusion, or <24 months after CARv3-TEAM-E infusion if subject discontinues due to disease progression or any other reason), subjects will be asked to participate in a long-term follow-up study.
This is a single site, non-randomized, open-label, long-term safety and efficacy follow-up Phase 1 study for subjects who have been treated with CARv3-TEAM-E T cells in clinical Study DF/HCC IRB #20-532 (the main study), that evaluated the safety and efficacy of CARv3-TEAM-E T cells in subjects with newly diagnosed or recurrent glioblastoma