Clinical trial · Interventional
rHSC-DIPGVax Plus Checkpoint Blockade for the Treatment of Newly Diagnosed DIPG and DMG
A Phase I Clinical Trial of Neo-antigen Heat Shock Protein Vaccine (rHSC-DIPGVax) in Combination With Checkpoint Blockade for the Treatment of Diffuse Intrinsic Pontine Glioma (DIPG) and Diffuse Midline Glioma in Childhood
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase I, open label, plus expansion clinical trial evaluating the safety and tolerability of rHSC-DIPGVax in combination with BALSTILIMAB and ZALIFRELIMAB. rHSC-DIPGVax is an off-the-shelf neo-antigen heat shock protein containing 16 peptides reflecting neo-epitopes found in the majority of DIPG and DMG tumors. Newly diagnosed patients with DIPG and DMG who have completed radiation six to ten weeks prior to enrollment are eligible.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Intrinsic Pontine Glioma | Diffuse Intrinsic Pontine Glioma | ONTOLOGY_EXACT | 0.98 |
| Diffuse Midline Glioma, H3 K27M-Mutant | Diffuse Midline Glioma, H3 K27M-Mutant | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Balstilimab | Drug | — | UNRESOLVED |
| rHSC-DIPGVax | Biological | — | UNRESOLVED |
| Zalifrelimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- "Lead In": rHSC-DIPGVax Monotherapy
- description
- rHSC-DIPGVax for 8 total doses
- interventionNames
- Biological: rHSC-DIPGVax
- type
- EXPERIMENTAL
- label
- Part A: rHSC-DIPGVax in Combination with BALSTILIMAB (Anti-PD1)
- description
- rHSC-DIPGVax (8 total doses) + BALSTILIMAB (1 year of therapy or 27 cycles, whichever comes first) Patients will enroll 6-10 weeks post standard of care (SOC) radiation completion. Steroid dose must be at or below 0.5mg/kg/day for a minimum of 7 days. The first 3 patients must be 5 years or older to 18. Subsequently, subjects ages 12 months to 18 years can be enrolled. Up to six patients will be enrolled on Part A. Once safety is established for rHSC-DIPGVax plus anti-PD1 (BALSTILIMAB), the study will proceed to Part B.
- interventionNames
- Biological: rHSC-DIPGVax
- Drug: Balstilimab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Months
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Subjects with newly diagnosed typical or non-typical, biopsy-proven DIPG or DMG are eligible for study enrollment. Biopsy is not required for subjects with radiographically typical DIPG meeting imaging criteria. Biopsy is required for DMG's and non-radiographically typical DIPG. Histone mutation must be confirmed by pathology report. Radiographically typical DIPG defined as a tumor with a pontine epicenter and diffuse involvement of more than 2/3 of the pons.
= Subjects ages \> or = to 12 months and \< or = 18 years ("Lead In", Part A, and Part B require first three patients be \> or = to 12 years of age)
* BSA \> or = 0.35m2 at the time of study enrollment
* Performance score: Karnofsky \>50% of subjects \>16 years of age and Lansky \> or = 50 for subjects \< or = 16 years of age. Subjects who are unable to walk because of paralysis but are up in a wheelchair will be considered ambulatory for the purpose of assessing the performance score.
* Must start radiation therapy within 42 days from date of diagnostic imaging. C1D1 must be within 42 days to 70 days post radiation (6-10 weeks). Patients CANNOT receive temozolomide during radiation
* Corticosteroids should be weaned as tolerated after radiation therapy with the goal of \< or = 0.5mg/kg/day for a minimum of 7 days prior to enrollment.
* Subjects must have measurable disease
Exclusion Criteria:
* Patients cannot receive temozolomide during radiation
* Disseminated disease
* Subjects who have received any cancer therapy except for radiation
* Autoimmune or immune disorders
* Active respiratory disorder or infection
* Active viral infectionReferences
Publications (0)
Data not yet available