Combination immunotherapy for newly diagnosed DIPG and DMG

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase I clinical trial evaluates the safety and tolerability of rHSC-DIPGVax combined with checkpoint inhibitors Balstilimab and Zalifrelimab in patients with newly diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) and Diffuse Midline Glioma (DMG). The trial employs a 3+3 design, starting with older children aged 5 to 18 years before including younger patients aged 12 months to 18 years. The study aims to enhance the immune response against these tumors by combining a cancer vaccine with therapies that inhibit negative regulatory pathways in the tumor microenvironment. Participants must have completed radiation therapy six to ten weeks prior to enrollment.

Why it matters

Who can join: the full rules

Inclusion 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.

  = 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 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

Exclusion Criteria:

* 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

Where it's running

• Children's Health Orange County (CHOC)
  Orange, California, United States Recruiting
• Ann and Robert H. Lurie Children's Hospital of Chicago
  Chicago, Illinois, United States Recruiting
• Dana-Farber Boston Children's Cancer and Blood Disorders Center
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Ashley Plant-Fox, MD — Ann and Robert H. Lurie Children's Hospital
• Study coordinator: Monica Newmark, BS, RN
• Email: MNewmark@luriechildrens.org
• Phone: 312-227-4847

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.