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 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.

Trial Details

NCT ID
NCT04943848
Phase
PHASE1
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Status
RECRUITING
Cancer Type
Brain Cancer
Interventions
  • rHSC-DIPGVax
  • Balstilimab
  • Zalifrelimab
Locations (sample)
  • Orange, California, United States|33.78779,-117.85311
  • Chicago, Illinois, United States|41.85003,-87.65005
  • Boston, Massachusetts, United States|42.35843,-71.05977

Key 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 subje…
  • = Subjects ages \> or = to 12 months and \< or = 18 years ("Lead In", Part A, and Part B require first three patients be \> or = to 12 years of age)
  • 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 unabl…

For full eligibility, visit ClinicalTrials.gov.

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