Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM)
Public ClinicalTrials.gov record NCT05685004. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05685004
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 120 participants
Conditions and interventions
Conditions
Interventions
- TVI-Brain-1 Biological
- Standard of Care Procedure
- Radiotherapy Radiation
- Temozolomide Drug
Biological · Procedure · Radiation + 1 more
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 27, 2023 (Actual)
- Primary completion
- Nov 2030 (Estimated)
- Completion
- Nov 2030 (Estimated)
- Last update posted
- Sep 29, 2026
2023 – 2030
United States locations
- U.S. sites
- 8
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Center for Neurosciences | Tucson | Arizona | 85718 | — |
| Cedar-Sanai Medical Center | Los Angeles | California | 90048 | — |
| University of Southern California Keck School of Medicine | Los Angeles | California | 90048 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| Piedmont | Atlanta | Georgia | 30309 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66061 | — |
| Capital Health | Pennington | New Jersey | 08534 | — |
| Providence St. Vincent | Portland | Oregon | 97225 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05685004, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 29, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05685004 live on ClinicalTrials.gov.