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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: Recruiting 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.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of DLT's per CTCAE version 5.0 and iRANO guidelines.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2022-01-10 |
| Est. Completion | 2027-09 |
| Phase | Phase 1 |
What NCT04943848 shows while recruiting
NCT04943848 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 134-participant average among 28 other Diffuse Intrinsic Pontine Glioma trials with a reported enrollment target (73% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT04943848's enrollment target sits among peer trials
36 16th of 28 higher than 12 of 28 other Diffuse Intrinsic Pontine Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diffuse Intrinsic Pontine Glioma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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