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| Diagnosis | Diffuse Intrinsic Pontine Glioma (DIPG), Diffuse Midline Glioma, H3 K27M-Mutant | Study Status | Open |
| Phase | I |
| Age | 12 Months to 18 Years | Randomisation | NO |
| Line of treatment | First line treatment |
| Routes of Treatment Administration | Biological: rHSC-DIPGVax (vaccine)
Drug: Balstilimab
Drug: Zalifrelimab |
| Last Posted Update | 2025-08-27 |
| ClinicalTrials.gov # | NCT04943848 |
International Sponsor
Ann & Robert H Lurie Children's Hospital of ChicagoPrincipal Investigators for Canadian Sites
Alberta Children's Hospital - Dr. Aru NarendranCentres
Medical contact
Dr. Victor Lewis
Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
Study Description
This study is testing a new treatment for children with DIPG or DMG brain tumors who have recently finished radiation. The treatment combines a vaccine (rHSC-DIPGVax) with two medicines, BALSTILIMAB and ZALIFRELIMAB. The main goal is to see if this combination is safe and can be tolerated. Patients may join if they were diagnosed with DIPG or DMG and completed radiation about 6–10 weeks before entering the study.
Inclusion Criteria
- Participants must be 12 months - 18 years old with newly diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) or Diffuse Midline Glioma (DMG)
- Must have measurable tumor on scans
- Body size (BSA) must be at least 0.35 m²
- Must be up and about at least 50% of waking hours
Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.
