Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM)
Condition(s) studied
Investigational drug(s) / intervention(s)
TVI-Brain-1: Attenuated autologous cancer cells and activated autologous blood-derived t cells
Standard of Care: Surgery for tumor removal or debulking to minimize tumor burden
Radiotherapy: Conformal radiotherapy consists of fractionated focal irradiation at a dose of 2 Gy per fraction given once daily five days per week (Monday through Friday) over a period of six weeks.
Temozolomide: All Subjects receive 75 mg/m2 of temozolomide daily beginning on the first day of radiotherapy and continuing until the completion of radiotherapy. Standard of care Subjects will also receive adjuvant temozolomide .
Study 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.
Eligibility
Primary outcome measure(s)
- Survival — From date of randomization until the date of death from any cause assessed up to 24 months after randomization.
All Subjects will be evaluated and contacted to evaluate their status
Trial sites (8)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 | |
| Piedmont | Atlanta | Georgia | |
| University of Kansas Medical Center | Kansas City | Kansas | |
| Capital Health | Pennington | New Jersey | |
| Providence St. Vincent | Portland | Oregon |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05685004 on ClinicalTrials.gov ↗ ← All trials in the USA