New hope for kids with tough brain tumors: gene therapy meets immunotherapy and radiation

NCT ID NCT07017816

Recruiting now Disease control Sponsor: Children's National Research Institute Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial is testing a combination of three treatments for children whose brain tumors have come back or not responded to standard care. The experimental drug SGT-53 delivers a normal TP53 gene to tumor cells, and is given alongside the immunotherapy Nivolumab and radiation therapy. The main goals are to find a safe dose of SGT-53 and to understand its side effects and how it moves through the body. Only 18 children will take part.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: SGT-53 (a drug that delivers a normal TP53 gene to cancer cells), Nivolumab (an immunotherapy), and radiation therapy
What this could lead to: If it works, this could point toward a new treatment option for children with hard-to-treat brain tumors that have come back or not responded to standard therapy.
What could go wrong: This is a very early (phase 0/1) and small trial (18 participants), so it is mainly testing safety and dosing. It may not show clear benefit, and side effects from the combination could be significant.

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Conditions

The condition(s) this trial relates to.

atypical teratoid rhabdoid tumor central nervous system cancer central nervous system sarcoma childhood central nervous system primitive neuroectodermal neoplasm embryonal neoplasm ependymoma malignant glioma medulloblastoma Neoplasms, Germ Cell and Embryonal Pinealoma pineoblastoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ATRT RECURRENT CNS MALIGNANCIES EMBRYONAL NEOPLASM EPENDYMOMA RECURRENT HIGH GRADE GLIOMAS MEDULLOBLASTOMA RECURRENT PINEOBLASTOMA

Contacts and locations

Locations

Children's National Hospital
RECRUITING

Washington D.C., District of Columbia, 20010, United States

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