Overview

Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed o6-methylguanine-DNA-methyltransferase (MGMT) Negative Glioblastoma Multiforme (GBM)

Status:
Not yet recruiting

Trial end date:
2026-03-01

Target enrollment:

Participant gender:

Summary

This randomized study is designed to compare the combination of TVI-Brain-1 immunotherapy and standard therapy compared to standard therapy alone as a treatment for newly diagnosed MGMT unmethylated glioblastoma patients. The patients' own cancer cells collected after surgery are combined into a vaccine to produce an immune response that significantly increases the number of cancer neoantigen-specific effector T cell precursors in the patient's body. These cancer neoantigen-specific T cells are harvested from the blood, subsequently stimulated and expanded, and infused back into the patient.

Phase:

Phase 2/Phase 3

Details

Lead Sponsor:

TVAX Biomedical

Collaborator:

FDA Office of Orphan Products Development

Treatments:

Temozolomide