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

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.

Inclusion Criteria:Newly diagnosed MGMT unmethylated glioblastoma multiforme (no prior treatment)Sufficient cancer tissue obtained to allow for manufacture of autologous cancer cell vaccinesThe attenuated autologous cancer cell product generated has satisfied the product release criteria as determined by the sponsor quality control departmentMedical history, physical examination and laboratory testing performed within approximately 7 days before enrollment revealing kidney and liver organ function within normal limitsnot currently receiving glucocorticoids and have been off glucocorticoids for at least 24 hours prior to vaccination as well as when they receive the T cell infusion.Patient function assessment (Karnofsky score is > 60)a life expectancy of > 12 weeks.Hemoglobin is > 10 g/dL (may be transfused)White blood cell count is > 3,000 cells/microliter (mcL) of blood.Platelet count is > 100,000 platelets per mcL of blood (transfusion independent)Lymphocyte count is > 1,000 cells/mcL of blood.Exclusion Criteria:another concomitant life-threatening disease (not including glioblastoma multiforme)a second malignancy that is not in remission as determined by the clinical investigator. Exception: squamous or basal cell carcinoma of the skin.requirement for treatment with glucocorticoids to control brain swellingpresence of active autoimmune disease that is currently being actively treated.psychological, familial, sociological or geographical conditions that do not permit adequate medical follow-up and compliance with the study protocol.Current pregnancy or a plan to become pregnant within 1-year following the study.