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RECRUITING Phase 1

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

NCT04943848 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Balstilimab
  • DRUG Zalifrelimab
  • BIOLOGICAL rHSC-DIPGVax

Study Locations (3)

California

  • Children's Health Orange County (CHOC) — Orange

Illinois

  • Ann and Robert H. Lurie Children's Hospital of Chicago — Chicago

Massachusetts

  • Dana-Farber Boston Children's Cancer and Blood Disorders Center — Boston

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2022-01-10
Est. Completion 2027-09
Phase Phase 1

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04943848

The ClinicalTrials.gov registry entry for NCT04943848 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ann & Robert H Lurie Children's Hospital of Chicago, which has 69 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Diffuse Intrinsic Pontine Glioma appearing as the primary indexed condition, and to 3 interventions — of which Balstilimab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04943848 reports 3 study locations spanning 3 distinct geographic areas — top geographies include California, Illinois, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04943848 about?

NCT04943848 is a clinical study titled "rHSC-DIPGVax Plus Checkpoint Blockade for the Treatment of Newly Diagnosed DIPG and DMG". 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 o...

What is the current status of trial NCT04943848?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2022-01-10. Estimated completion is 2027-09.

What conditions does trial NCT04943848 study?

This clinical trial studies the following conditions: Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04943848?

The interventions under investigation include: Balstilimab (DRUG), Zalifrelimab (DRUG), rHSC-DIPGVax (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04943848?

This trial is sponsored by Ann & Robert H Lurie Children's Hospital of Chicago, which has 69 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04943848 being conducted?

This trial has 3 study locations across California, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial