RecruitingPhase 1NCT04943848

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

A Phase I Clinical Trial of Neo-antigen Heat Shock Protein Vaccine (rHSC-DIPGVax) in Combination With Checkpoint Blockade for the Treatment of Diffuse Intrinsic Pontine Glioma (DIPG) and Diffuse Midline Glioma in Childhood


Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Enrollment

36 participants

Start Date

Jan 10, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 12 MonthsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new cancer vaccine (rHSC-DIPGVax) combined with checkpoint blockade immunotherapy drugs for children and young people newly diagnosed with DIPG (diffuse intrinsic pontine glioma) or DMG (diffuse midline glioma) — aggressive brain cancers with very limited treatment options. **You may be eligible if...** - Your child has been newly diagnosed with DIPG or DMG (a specific type of brainstem or midline brain tumor) - Diagnosis is confirmed by biopsy or by MRI imaging that meets standard criteria - Your child is between 12 months and 18 years old - Your child has adequate physical strength (Karnofsky or Lansky score ≥50) **You may NOT be eligible if...** - Your child has already received treatment for this brain tumor - The diagnosis does not meet criteria for DIPG or DMG - Your child has serious medical conditions that would prevent participation - Your child is too frail or underweight for the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALrHSC-DIPGVax

Off-the-shelf, neoantigen heat shock protein vaccine

DRUGBalstilimab

BALSTILIMAB is a human monoclonal antibody that targets programmed cell death 1 (PD1)

DRUGZalifrelimab

ZALIFRELIMAB is a human monoclonal immunoglobulin G1k subclass (IgG1k) antibody that specifically recognizes cytotoxic T lymphocyte-associated protein 4 (CTLA-4, also known as CD152)


Locations(3)

Children's Health Orange County (CHOC)

Orange, California, United States

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

Chicago, Illinois, United States

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

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT04943848


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