Spots Global Cancer Trial Database for Long-term Follow-up of Subjects Treated With CARv3-TEAM-E T Cells

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Trial Identification

Brief Title: Long-term Follow-up of Subjects Treated With CARv3-TEAM-E T Cells

Official Title: Long-term Follow-up of Subjects Treated With CARv3-TEAM-E T Cells

Study ID: NCT05024175

Conditions

Glioblastoma Recurrent, EGFR vIII Mutant

Newly Diagnosed Glioblastoma, EGFRvIII Mutant

Recurrent Glioblastoma, EGFR vIII Negative

Interventions

Disease assessments

Tumor Biopsy

Blood test

Study Description

Brief Summary: 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

Detailed Description: 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.