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RECRUITING
NCT04943848
PHASE1

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

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

12 Months - 18 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2022-01-10

Completion Date

2027-09

Last Updated

2026-03-17

Healthy Volunteers

No

Interventions

BIOLOGICAL

rHSC-DIPGVax

Off-the-shelf, neoantigen heat shock protein vaccine

DRUG

Balstilimab

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

DRUG

Zalifrelimab

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