drugset / Trial / NCT05096481

PEP-CMV Vaccine Targeting CMV Antigen to Treat Newly Diagnosed Pediatric HGG and DIPG and Recurrent Medulloblastoma

NCT05096481

NaSingle-groupOpen-labelTreatment

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

Timeline

Start
2024-07-18
Primary completion
2028-06-15
Completion
2030-06-15

Drugs

EvaluationDrugModalityDoseRoute
Subject PEP-CMV Vaccine 250 ug/m2 Other
Background Temozolomide Small molecule 200 mg/m2
Background Tetanus Diphtheria Vaccine Vaccine 1 unknown Other
Background Tetanus Diphtheria Vaccine Vaccine 5 unknown Other