NCT04943848 rHSC-DIPGVax Plus Checkpoint Blockade for the Treatment of Newly Diagnosed DIPG and DMG
| NCT ID | NCT04943848 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Ann & Robert H Lurie Children's Hospital of Chicago |
| Condition | Diffuse Intrinsic Pontine Glioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2022-01-10 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 36 participants in total. It began in 2022-01-10 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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 infection
Contact & Investigator
Ashley Plant-Fox, MD
PRINCIPAL INVESTIGATOR
Ann and Robert H. Lurie Children's Hospital
Frequently Asked Questions
Who can join the NCT04943848 clinical trial?
This trial is open to participants of all sexes, aged 12 Months or older, up to 18 Years, studying Diffuse Intrinsic Pontine Glioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04943848 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04943848 currently recruiting?
Yes, NCT04943848 is actively recruiting participants. Contact the research team at MNewmark@luriechildrens.org for enrollment information.
Where is the NCT04943848 trial being conducted?
This trial is being conducted at Orange, United States, Chicago, United States, Boston, United States.
Who is sponsoring the NCT04943848 clinical trial?
NCT04943848 is sponsored by Ann & Robert H Lurie Children's Hospital of Chicago. The principal investigator is Ashley Plant-Fox, MD at Ann and Robert H. Lurie Children's Hospital. The trial plans to enroll 36 participants.