A Phase 0/1 Study of cDNA for TP53, Checkpoint Inhibition and Radiation in Children With Recurrent, Progressive or Refractory CNS Malignancies.
Public ClinicalTrials.gov record NCT07017816. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
JACOB: Joint Administration of cDNA for TP53, checkpOint Inhibition and Boost/Hypofractionated Radiation. A Phase 0/1 Study in Children With Recurrent, Progressive or Refractory CNS Malignancies.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This clinical trial is studying a drug called SGT-53 along with radiation and another drug called Nivolumab. It's for children with brain tumors that have come back, gotten worse, or didn't get better with earlier treatments. The main questions it aims to answer are: What is the right dose of SGT-53 that children can safely receive when it is used with radiation and Nivolumab? This dose will be used in the second phase of the trial. What side effects are there of SGT-53 when it is used with radiation and Nivolumab? How does SGT-53 move through the body when given with radiation and Nivolumab? How much of the SGT-53 drug is found in the tumor tissue? This will be tested in a small group of patients? Participants will: For the first treatment cycle: Get SGT-53 twice per week Get Nivolumab every 2 weeks Receive radiation therapy during week 2 For Cycles 2-6: Get SGT-53 once per week during even cycles and twice per week during odd cycles Get Nivolumab every 2 weeks For Cycles 7+ Get both SGT-53 and Nivolumab every 2 weeks In the phase 0 part of the study, 4 participants will have genetic testing performed on their tumor tissue after receiving SGT-53. These samples will be compared to another sample taken from the skin.
Study identification
- NCT ID
- NCT07017816
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Early Phase 1
- Enrollment
- 18 participants
Conditions and interventions
Conditions
Interventions
- SGT-53 Drug
- hypofractionated radiotherapy with immunotherapy Radiation
- Nivolumab Drug
Drug · Radiation
Eligibility (public fields only)
- Age range
- 3 Years to 21 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 15, 2025
- Primary completion
- Apr 30, 2028
- Completion
- Apr 30, 2028
- Last update posted
- Apr 28, 2026
2025 – 2028
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's National Hospital | Washington D.C. | District of Columbia | 20010 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07017816, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 28, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07017816 live on ClinicalTrials.gov.