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

Part of paid clinical trials in Orange, California.

Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Study ID
NCT04943848
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
12 Months - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • rHSC-DIPGVax — BIOLOGICAL
    Off-the-shelf, neoantigen heat shock protein vaccine
  • Balstilimab — DRUG
    BALSTILIMAB is a human monoclonal antibody that targets programmed cell death 1 (PD1)
  • Zalifrelimab — DRUG
    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)

Study Details

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.

Key Dates

Start date
Jan 10, 2022
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: "Lead In": rHSC-DIPGVax Monotherapy
    rHSC-DIPGVax for 8 total doses
  • Experimental: Part A: rHSC-DIPGVax in Combination with BALSTILIMAB (Anti-PD1)
    rHSC-DIPGVax (8 total doses) + BALSTILIMAB (1 year of therapy or 27 cycles, whichever comes first) Patients will enroll 6-10 weeks post standard of care (SOC) radiation completion. Steroid dose must be at or below 0.5mg/kg/day for a minimum of 7 days. The first 3 patients must be 5 years or older to 18. Subsequently, subjects ages 12 months to 18 years can be enrolled. Up to six patients will be enrolled on Part A. Once safety is established for rHSC-DIPGVax plus anti-PD1 (BALSTILIMAB), the study will proceed to Part B.
  • Experimental: Part B: Dose Escalation of ZALIFRELIMAB (Anti-CTLA4)
    rHSC-DIPGVax (8 total doses) + BALSTILIMAB + ZALIFRELIMAB (1 year of therapy or 9 cycles, whichever comes first) Patients will enroll 6-10 weeks post standard of care (SOC) radiation therapy. Steroid dose must be at or below 0.5mg/kg/day for a minimum of 7 days. The first 3 patients must be 5 years or older to 18. Subsequently, subjects ages 12 months to 18 years can be enrolled. Up to 12 patients will be enrolled on Part B. Once safety is established for rHSC-DIPGVax plus anti-PD1 (BALSTILIMAB) plus anti-CTLA4 (ZALIFRELIMAB), the study will proceed to Part C.
  • Experimental: Part C: Dose Expansion
    rHSC-DIPGVax (8 total doses) + BALSTILIMAB + ZALIFRELIMAB (at RP2D from Part B) (1 year of therapy or 9 cycles, whichever comes first) Patients will enroll 6-10 weeks post standard of care (SOC) radiation therapy. Steroid dose must be at or below 0.5mg/kg/day for a minimum of 7 days. Up to 12 patients will be enrolled on Part C. All subjects in Part C will be monitored for DLT's for the duration of their participation in the study to monitor for excess toxicity.

Primary Outcome Measure

Safety and Tolerability: Dose limiting toxicities of rHSC-DIPGVax [ Time Frame: DLT period of 28 days for rHSC-DIPGVax monotherapy ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Children's Health Orange County (CHOC)OrangeCalifornia92868
Mariko Sato, MD
[email protected]
714-509-8636
Claudia Mousa
[email protected]
714-509-8724
Mariko Sato, MD (PRINCIPAL_INVESTIGATOR)
Ann and Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611
Ashley S Plant, MD
[email protected]
312-227-4090
Monica Newmark, BS
[email protected]
312-227-4847
Ashley S Plant, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Boston Children's Cancer and Blood Disorders CenterBostonMassachusetts02215
Alexa E Stathis
[email protected]
857-215-1558
Susan Chi, MD
[email protected]
617-632-4386
Susan Chi, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Orange, CA

By research site
Children's Health Orange County (CHOC)· Orange, CAAnn and Robert H. Lurie Children's Hospital of Chicago· Chicago, ILDana-Farber Boston Children's Cancer and Blood Disorders Center· Boston, MA

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