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rHSC-DIPGVax, Balstilimab, and Zalifrelimab for DIPG and DMG

This study is testing a new treatment for children and young adults (ages 12 months to 18 years) with newly diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) or Diffuse Midline Glioma (DMG). The treatment combines a vaccine called rHSC-DIPGVax with two other medications, Balstilimab and Zalifrelimab. The vaccine is designed to help your body's immune system fight the cancer. Balstilimab and Zalifrelimab are immunotherapy drugs that work by targeting specific proteins (PD1 and CTLA-4) to boost the immune response. This study is looking at how safe these treatments are and what side effects they might cause. Participants must have a confirmed H3 K27M histone mutation in their tumor and have completed radiation therapy 6 to 10 weeks before joining.

Study design
This is a Phase 1, open-label study, meaning everyone knows which treatment they are receiving. It plans to enroll 36 participants to evaluate the safety and tolerability of the treatments.
What's involved
The study will assess safety and tolerability of rHSC-DIPGVax alone for 28 days, then rHSC-DIPGVax plus Balstilimab for 28 days, and finally rHSC-DIPGVax plus Balstilimab and Zalifrelimab for 42 days.
Compensation
Not stated in the trial record.
Follow-up
The study measures safety and tolerability for 28 days after starting rHSC-DIPGVax alone, 28 days after starting rHSC-DIPGVax plus Balstilimab, and 42 days after starting rHSC-DIPGVax plus Balstilimab and Zalifrelimab.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04943848

rHSC-DIPGVax Plus Checkpoint Blockade for the Treatment of Newly Diagnosed DIPG and DMG

Recruiting
PHASE1Ages 12–18InterventionalTreatment
Ann & Robert H Lurie Children's Hospital of Chicago
~36 participants
Updated 2026-03-17 on ClinicalTrials.gov
What's tested:rHSC-DIPGVaxBalstilimabZalifrelimab

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Tolerability: Dose limiting toxicities of rHSC-DIPGVax
Measured over DLT period of 28 days for rHSC-DIPGVax monotherapy
+2 more outcomes measured

Conditions

Diffuse Intrinsic Pontine Glioma
Diffuse Midline Glioma, H3 K27M-Mutant

Explore related trials

Diffuse Intrinsic Pontine GliomaDiffuse Midline GliomaH3 K27M Variant

Where it's being run

3 sites across 3 states
California1
Illinois1
Massachusetts1

Study leadership

  • Ashley Plant-Fox, MD · PRINCIPAL_INVESTIGATOR · Ann and Robert H. Lurie Children's Hospital

Who to contact

Monica Newmark, BS, RN
[email protected]
312-227-4847
Email the study team

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Eligibility criteria

Inclusion

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.
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

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 infection

What this trial measures

  • Safety and Tolerability: Dose limiting toxicities of rHSC-DIPGVaxDLT period of 28 days for rHSC-DIPGVax monotherapy

    Number of DLT's per CTCAE version 5.0 and iRANO guidelines.

  • Safety and Tolerability: Dose limiting toxicities of rHSC-DIPGVax plus BALSTILIMABDLT period of 28 days for Part A

    Number of DLT's per CTCAE version 5.0 and iRANO guidelines.

  • Safety and Tolerability: Dose limiting toxicities of rHSC-DIPGVax plus BALSTILIMAB and ZALIFRELIMABDLT period of 42 days for Part B

    Number of DLT's per CTCAE version 5.0 and iRANO guidelines.