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NCT06914479 · ClinicalTrials.gov registry record · Phase 1
Virus-Based Gene Therapy (AdV-HSV1-TK and AdV-Flt3L) in Combination With Valacyclovir for the Treatment of Pediatric and Young Adult Patients With Resectable, Recurrent Primary Malignant Brain Tumors
A Phase 1 study of Recurrent Malignant Brain Neoplasm and Recurrent Diffuse Hemispheric Glioma, H3 G34-Mutant, sponsored by University of Michigan Rogel Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT06914479: Recruiting Phase 1 study of Recurrent Malignant Brain Neoplasm and Recurrent Diffuse Hemispheric Glioma, H3 G34-Mutant, sponsored by University of Michigan Rogel Cancer Center.
NCT06914479 is a Phase 1 study of Recurrent Malignant Brain Neoplasm and Recurrent Diffuse Hemispheric Glioma, H3 G34-Mutant that is actively recruiting participants, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06914479, a Phase 1 study of Recurrent Malignant Brain Neoplasm and Recurrent Diffuse Hemispheric Glioma, H3 G34-Mutant, is actively recruiting participants, sponsored by University of Michigan Rogel Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial tests the safety, side effects and best dose of AdV-HSV1-TK and AdV-Flt3L in combination with valacyclovir for the treatment of patients with primary cancerous (malignant) brain tumors that can be removed by surgery (resectable) and that have come back after a period of improvement (recurrent). AdV-HSV1-TK and AdV-Flt3L use a virus modified in the laboratory to kill tumor cells and stimulate the immune system to recognize the tumor cells as "invaders" which can lead to tumor shrinkage. For this process to work, an oral anti-herpes medication called valacyclovir is also needed. Giving AdV-HSV1-TK, AdV-Flt3L and valacyclovir may be safe, tolerable and/or effective in treating patients with resectable, recurrent primary malignant brain tumors.
Primary Outcome
Each participant will be classified as either having a DLT prior to Day 21 after dual vector administration or Day 21 after dual vector administration with no DLT (a binary endpoint). Adverse events (AEs) will be defined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Magnetic Resonance Imaging
- OTHER Survey Administration
- GENETIC Ad-hCMV-Flt3L
- GENETIC Ad-hCMV-TK
Study Locations (1)
Michigan
- University of Michigan Comprehensive Cancer Center - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2026-06-01 |
| Est. Completion | 2031-06-01 |
| Phase | Phase 1 |
What NCT06914479 shows while recruiting
NCT06914479 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 3 conditions, with Recurrent Malignant Brain Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06914479 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT06914479 about?
NCT06914479 is a clinical study titled "Virus-Based Gene Therapy (AdV-HSV1-TK and AdV-Flt3L) in Combination With Valacyclovir for the Treatment of Pediatric and Young Adult Patients With Resectable, Recurrent Primary Malignant Brain Tumors". This phase I trial tests the safety, side effects and best dose of AdV-HSV1-TK and AdV-Flt3L in combination with valacyclovir for the treatment of patients with primary cancerous (malignant) brain tumors that can be removed by surgery (resectable) and that have come back after a period of improvemen...
What is the current status of trial NCT06914479?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2026-06-01. Estimated completion is 2031-06-01.
What conditions does trial NCT06914479 study?
This clinical trial studies the following conditions: Recurrent Malignant Brain Neoplasm, Recurrent Diffuse Hemispheric Glioma, H3 G34-Mutant, Resectable Brain Neoplasm.
What interventions are being tested in trial NCT06914479?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Survey Administration (OTHER), Ad-hCMV-Flt3L (GENETIC), Ad-hCMV-TK (GENETIC).
Who is sponsoring clinical trial NCT06914479?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06914479 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06914479's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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