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Phase 2 trial of a novel peptide vaccine (PEP-CMV) targeting CMV antigen for newly diagnosed pediatric high-grade glioma and diffuse intrinsic pontine glioma and recurrent medulloblastoma


Primary Investigator
Prensner, John
Status
OPEN TO ACCRUAL
Phase
II
NCT Number
NCT05096481
UM Number
2025.108
Age Group
Children
Management Group
CTSU - Michigan
Oncology Group
Childhood Cancers
ID (Protocol)
60767
Secondary Protocol No
HUM00278879
Scope
Unspecified
Sponsor Type
Institutional

Disease Site
Brain and Nervous System

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

Eligibility: