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NCT05096481 · ClinicalTrials.gov registry record · Phase 2
PEP-CMV Vaccine Targeting CMV Antigen to Treat Newly Diagnosed Pediatric HGG and DIPG and Recurrent Medulloblastoma
A Phase 2 study of High Grade Glioma and Diffuse Intrinsic Pontine Glioma, sponsored by Nationwide Children's Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 12
- Study locations
NCT05096481 is a Phase 2 study of High Grade Glioma and Diffuse Intrinsic Pontine Glioma that is actively recruiting participants, run by Nationwide Children's Hospital. The registered enrollment target is 120 participants, above the 63-participant average among 42 other High Grade Glioma trials with a reported enrollment target (90% higher). The trial reports 12 study locations across 11 states.
The verdict
NCT05096481, a Phase 2 study of High Grade Glioma and Diffuse Intrinsic Pontine Glioma, is actively recruiting participants, sponsored by Nationwide Children's Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 12
- Study locations
Study Summary
This study will address the question of whether targeting CMV antigens with PEP-CMV can serve as a novel immunotherapeutic approach in pediatric patients with newly-diagnosed high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG) as well as recurrent medulloblastoma (MB). PEP-CMV is a vaccine mixture of a peptide referred to as Component A. Component A is a synthetic long peptide (SLP) of 26 amino acid residues from human pp65. The SLPs encode multiple potential class I, class II, and antibody epitopes across several haplotypes. Component A will be administered as a stable water:oil emulsion in Montanide ISA 51. Funding Source - FDA OOPD
Conditions Studied
Interventions
- DRUG Temozolomide
- BIOLOGICAL PEP-CMV
- BIOLOGICAL Tetanus Diphtheria Vaccine
Study Locations (12)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Nationwide Children's Hospital - Columbus
Colorado
- Children's Hospital Colorado - Aurora
District of Columbia
- Children's National Medical Center - Washington D.C.
Florida
- Nicklaus Children's Hospital - Miami
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Massachusetts
- Dana-Farber Cancer Institute - Boston
Missouri
- St. Louis Children's Hospital - St Louis
North Carolina
- Duke Cancer Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2024-07-18 |
| Est. Completion | 2030-06-15 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05096481
The ClinicalTrials.gov registry entry for NCT05096481 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 63-participant average among 42 other High Grade Glioma trials with a reported enrollment target (90% higher). The listed sponsor is Nationwide Children's Hospital, which has 188 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with High Grade Glioma appearing as the primary indexed condition, and to 3 interventions - of which Temozolomide is the first listed.
NCT05096481 reports 12 study locations spanning 11 distinct geographic areas - top geographies include Ohio, Colorado, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT05096481 about?
NCT05096481 is a clinical study titled "PEP-CMV Vaccine Targeting CMV Antigen to Treat Newly Diagnosed Pediatric HGG and DIPG and Recurrent Medulloblastoma". This study will address the question of whether targeting CMV antigens with PEP-CMV can serve as a novel immunotherapeutic approach in pediatric patients with newly-diagnosed high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG) as well as recurrent medulloblastoma (MB). PEP-CMV is a v...
What is the current status of trial NCT05096481?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2024-07-18. Estimated completion is 2030-06-15.
What conditions does trial NCT05096481 study?
This clinical trial studies the following conditions: High Grade Glioma, Diffuse Intrinsic Pontine Glioma, Recurrent Medulloblastoma.
What interventions are being tested in trial NCT05096481?
The interventions under investigation include: Temozolomide (DRUG), PEP-CMV (BIOLOGICAL), Tetanus Diphtheria Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05096481?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05096481 being conducted?
This trial has 12 study locations across Colorado, District of Columbia, Florida, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.