Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM) (NCT05685004)
Randomized Phase 2b Study of Safety And Efficacy Of TVI-Brain-1 Combined With Conformal Radiotherapy And Temozolomide Vs Standard Therapy In Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM)
🩺 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: Review the eligibility criteria below.
Location: Center for Neurosciences — Tucson, Arizona
Age range: 18 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 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.
More studies in Glioblastoma Multiforme of Brain
- Trial of C134 in Patients With Recurrent GBM — Birmingham, Alabama
- GPC-3 CAR T CELLS FOR Recurrent GPC-3 Positive Glioblastoma — Houston, Texas
- A Phase 1 Safety and Dose Finding Study of GLIX1 in Adults With Recurrent or Progressive High-grade Glioma — Tampa, Florida
Explore by condition: All Glioblastoma Multiforme of Brain clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.