Actively Recruiting
rHSC-DIPGVax Plus Checkpoint Blockade for the Treatment of Newly Diagnosed DIPG and DMG
Led by Ann & Robert H Lurie Children's Hospital of Chicago · Updated on 2026-03-17
36
Participants Needed
3
Research Sites
294 weeks
Total Duration
On this page
Sponsors
A
Ann & Robert H Lurie Children's Hospital of Chicago
Lead Sponsor
D
Dana-Farber Cancer Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
rHSC-DIPGVax Plus Checkpoint Blockade for the Treatment of Newly Diagnosed DIPG and DMG
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with newly diagnosed typical or non-typical, biopsy-proven DIPG or DMG; biopsy not required for typical DIPG meeting imaging criteria
- Histone mutation confirmed by pathology report
- Radiographically typical DIPG defined as tumor with pontine epicenter and diffuse involvement of more than two-thirds of the pons
- Ages 12 months to 18 years (first three patients in Lead In, Part A, and Part B must be 12 years or older)
- Body surface area (BSA) of 0.35 m2 or more at enrollment
- Karnofsky performance score above 50% if over 16 years old; Lansky score 50 or higher if 16 years or younger
- Patients unable to walk due to paralysis but who use a wheelchair are considered ambulatory for performance scoring
- Radiation therapy started within 42 days from diagnostic imaging
- First day of treatment (Cycle 1 Day 1) within 42 to 70 days after radiation (6 to 10 weeks)
- No temozolomide during radiation therapy
- Corticosteroids reduced to 0.5 mg/kg/day or less for at least 7 days before enrollment
- Measurable disease present
You will not qualify if you...
- Receiving temozolomide during radiation therapy
- Disseminated disease
- Prior cancer therapy except radiation
- Autoimmune or immune disorders
- Active respiratory disorder or infection
- Active viral infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Children's Health Orange County (CHOC)
Orange, California, United States, 92868
Actively Recruiting
2
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
3
Dana-Farber Boston Children's Cancer and Blood Disorders Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
M
Monica Newmark, BS, RN
CONTACT
A
Ashley Plant-Fox, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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