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NCT05685004 · ClinicalTrials.gov registry record · Phase 2
Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM)
A Phase 2 study of Glioblastoma Multiforme of Brain, sponsored by TVAX Biomedical.
- Active
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 8
- Study locations
NCT05685004: Active Phase 2 study of Glioblastoma Multiforme of Brain, sponsored by TVAX Biomedical.
NCT05685004 is a Phase 2 study of Glioblastoma Multiforme of Brain that is active but no longer recruiting, run by TVAX Biomedical. The registered enrollment target is 120 participants, below the 148-participant average among 11 other Glioblastoma Multiforme of Brain trials with a reported enrollment target (19% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05685004, a Phase 2 study of Glioblastoma Multiforme of Brain, is active but no longer recruiting, sponsored by TVAX Biomedical.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 8
- Study locations
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.
Primary Outcome
All Subjects will be evaluated and contacted to evaluate their status
Conditions Studied
Interventions
- DRUG Temozolomide
- RADIATION Radiotherapy
- PROCEDURE Standard of Care
- BIOLOGICAL TVI-Brain-1
Study Locations (8)
California
- Cedar-Sanai Medical Center - Los Angeles
- University of Southern California Keck School of Medicine - Los Angeles
Arizona
- Center for Neurosciences - Tucson
Florida
- Moffitt Cancer Center - Tampa
Georgia
- Aaron Mammoser - Atlanta
Kansas
- University of Kansas Medical Center - Kansas City
New Jersey
- Capital Health - Pennington
Oregon
- Providence St. Vincent - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2023-09-15 |
| Est. Completion | 2027-03 |
| Phase | Phase 2 |
What the registry record for NCT05685004 still lists
NCT05685004 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 148-participant average among 11 other Glioblastoma Multiforme of Brain trials with a reported enrollment target (19% lower).
The record links to 1 condition, with Glioblastoma Multiforme of Brain appearing as the primary indexed condition, and to 4 interventions - of which Temozolomide is the first listed.
NCT05685004 lists 8 locations in 7 states (California, Arizona, Florida).
Frequently Asked Questions
What is clinical trial NCT05685004 about?
NCT05685004 is a clinical study titled "Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM)". 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 vac...
What is the current status of trial NCT05685004?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2023-09-15. Estimated completion is 2027-03.
What conditions does trial NCT05685004 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme of Brain.
What interventions are being tested in trial NCT05685004?
The interventions under investigation include: Temozolomide (DRUG), Radiotherapy (RADIATION), Standard of Care (PROCEDURE), TVI-Brain-1 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05685004?
This trial is sponsored by TVAX Biomedical, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05685004 being conducted?
This trial has 8 study locations across Arizona, California, Florida, Georgia, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05685004's enrollment target sits among peer trials
120 5th of 11 higher than 7 of 11 other Glioblastoma Multiforme of Brain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma Multiforme of Brain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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