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SGT-53, Nivolumab, and Radiation for Pediatric Recurrent Brain Tumors

This study is for children aged 3 to 21 with brain tumors (CNS malignancies) that have returned, gotten worse, or didn't respond to previous treatments. It's testing a drug called SGT-53, which aims to restore a normal gene (TP53) in cancer cells, along with radiation and another drug called Nivolumab. Researchers want to find the safest dose of SGT-53 when combined with these treatments, understand its side effects, and see how it moves through the body and into tumor tissue. The goal is to see if this combination can help children with these challenging cancers. The study plans to enroll 18 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 18 participants, but the phase is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for side effects from enrollment to 3 years after the end of treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07017816

A Phase 0/1 Study of cDNA for TP53, Checkpoint Inhibition and Radiation in Children With Recurrent, Progressive or Refractory CNS Malignancies.

Recruiting
EARLY_PHASE1Ages 3–21InterventionalTreatment
Children's National Research Institute
~18 participants
Updated 2026-04-29 on ClinicalTrials.gov
What's tested:SGT-53hypofractionated radiotherapy with immunotherapyNivolumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency and type of toxicity deemed at least probably related to SGT-53
Measured over From enrollment to 3 years from end of treatment.

Conditions

CNS Malignancies
Medulloblastoma Recurrent
ATRT Recurrent
Pineoblastoma
Embryonal Neoplasm
Ependymoma Recurrent
High Grade Gliomas

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Atypical Teratoid/Rhabdoid TumorCentral Nervous System SarcomaCNS MalignanciesEmbryonal NeoplasmEpendymomaMalignant GliomaMedulloblastomaPineoblastoma

Where it's being run

1 sites across 1 states
District of Columbia1

Who to contact

Julia Batarseh
[email protected]
202-476-5578
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Tumor
Patient Characteristics a. The first 3 patients will be \>7 years old to \<22 years old i. Following initial successful treatment of the first 3 patients: Patients must be ≥3yrs and \<22 years of age.

Exclusion

1\. Low-grade-glioma, craniopharyngioma, and other non-malignant CNS tumors are excluded.

What this trial measures

  • Frequency and type of toxicity deemed at least probably related to SGT-53From enrollment to 3 years from end of treatment.