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

Description

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

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Diffuse Intrinsic Pontine Glioma
Intervention / Treatment

-

Contacts and Locations

Orange

Children's Health Orange County (CHOC), Orange, California, United States, 92868

Chicago

Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States, 60611

Boston

Dana-Farber Boston Children's Cancer and Blood Disorders Center, Boston, Massachusetts, United States, 02215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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
  • * 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

Ages Eligible for Study

12 Months to 18 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ann & Robert H Lurie Children's Hospital of Chicago,

Ashley Plant-Fox, MD, PRINCIPAL_INVESTIGATOR, Ann and Robert H. Lurie Children's Hospital

Study Record Dates

2025-12