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NCT04943848 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Diffuse Intrinsic Pontine Glioma and Diffuse Midline Glioma, H3 K27M-Mutant, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.

Recruiting
Registry status
Phase 1
Development phase
36
Enrollment target
3
Study locations

NCT04943848 is a Phase 1 study of Diffuse Intrinsic Pontine Glioma and Diffuse Midline Glioma, H3 K27M-Mutant that is actively recruiting participants, run by Ann & Robert H Lurie Children's Hospital of Chicago. The registered enrollment target is 36 participants, below the 134-participant average among 28 other Diffuse Intrinsic Pontine Glioma trials with a reported enrollment target (73% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT04943848, a Phase 1 study of Diffuse Intrinsic Pontine Glioma and Diffuse Midline Glioma, H3 K27M-Mutant, is actively recruiting participants, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.

RECRUITING
Registry status
Phase 1
Development phase
36 participants
Enrollment target
3
Study locations

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.

Conditions Studied

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

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

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

159 total trials

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What the Registry Record Tells You About NCT04943848

The ClinicalTrials.gov registry entry for NCT04943848 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 134-participant average among 28 other Diffuse Intrinsic Pontine Glioma trials with a reported enrollment target (73% lower). The listed sponsor is Ann & Robert H Lurie Children's Hospital of Chicago, which has 159 total studies on file at ClinicalTrials.gov.

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.

NCT04943848 reports 3 study locations spanning 3 distinct geographic areas - top geographies include California, Illinois, Massachusetts.

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.

What interventions are being tested in trial NCT04943848?

The interventions under investigation include: Balstilimab (DRUG), Zalifrelimab (DRUG), rHSC-DIPGVax (BIOLOGICAL).

Who is sponsoring clinical trial NCT04943848?

This trial is sponsored by Ann & Robert H Lurie Children's Hospital of Chicago, which has 159 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.