drugset / Trial / NCT05096481
PEP-CMV Vaccine Targeting CMV Antigen to Treat Newly Diagnosed Pediatric HGG and DIPG and Recurrent Medulloblastoma
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |