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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TVAX Biomedical
• Collaborator: FDA Office of Orphan Products Development
• Treatments: Temozolomide

Criteria

Inclusion Criteria:

• Newly diagnosed MGMT unmethylated glioblastoma multiforme (no prior treatment)

• Sufficient cancer tissue obtained to allow for manufacture of autologous cancer cell vaccines

• The attenuated autologous cancer cell product generated has satisfied the product release criteria as determined by the sponsor quality control department

• Medical history, physical examination and laboratory testing performed within approximately 7 days before enrollment revealing kidney and liver organ function within normal limits

• not 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 swelling

• presence 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.