Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM)
Running, not enrolling · Phase 2/Phase 3
Conditions studied: Glioblastoma Multiforme of Brain
In brief
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.
Key facts
- Study ID
- NCT05685004
- Run by
- TVAX Biomedical
- People needed
- 120
- Starts
- 2023-09-15
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2025-07-01
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Center for Neurosciences — Tucson, Arizona, United States
- Cedar-Sanai Medical Center — Los Angeles, California, United States
- University of Southern California Keck School of Medicine — Los Angeles, California, United States
- Moffitt Cancer Center — Tampa, Florida, United States
- Aaron Mammoser — Atlanta, Georgia, United States
- University of Kansas Medical Center — Kansas City, Kansas, United States
- Capital Health — Pennington, New Jersey, United States
- Providence St. Vincent — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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