Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM) (NCT05685004)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (11 items) and avoid the listed exclusions (7 items).
Location: Center for Neurosciences — Tucson, Arizona
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (8 Sites)
- Center for Neurosciences — Tucson, Arizona
- Cedar-Sanai Medical Center — Los Angeles, California
- University of Southern California Keck School of Medicine — Los Angeles, California
- Moffitt Cancer Center — Tampa, Florida
- Aaron Mammoser — Atlanta, Georgia
- University of Kansas Medical Center — Kansas City, Kansas
- Capital Health — Pennington, New Jersey
- Providence St. Vincent — Portland, Oregon
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.