Actively Recruiting
JACOB: Joint Administration of cDNA for TP53, Checkpoint Inhibition and Boost/Hypofractionated Radiation in Children With Recurrent, Progressive or Refractory CNS Malignancies
Led by Children's National Research Institute · Updated on 2026-04-29
18
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of the drug SGT-53 in combination with radiation therapy and the drug Nivolumab in children with brain tumors that have returned, worsened, or not improved after previous treatments. This early-phase clinical trial aims to find the right dose of SGT-53 that can be safely given alongside radiation and Nivolumab. The study also investigates the side effects of SGT-53, how the drug moves through the body, and how much of it reaches the tumor tissue in a small group of patients. During the first treatment cycle, participants receive SGT-53 twice a week, Nivolumab every two weeks, and radiation therapy during the second week. In cycles two through six, SGT-53 is given once a week during even cycles and twice a week during odd cycles, while Nivolumab continues every two weeks. From cycle seven onward, both SGT-53 and Nivolumab are given every two weeks. In a special early part of the study, four participants will have genetic testing on tumor samples after receiving SGT-53 to compare with skin samples. Participants will be closely monitored throughout the study with evaluations of side effects related to SGT-53 from enrollment to three years after treatment ends. Researchers will assess the drug's safety, how it is processed in the body, and its presence in tumor tissue. The study includes clinical and radiological assessments, genetic testing, and ongoing safety monitoring to understand the treatment's effects over time.
CONDITIONS
Brief Title
A Phase 0/1 Study of cDNA for TP53, Checkpoint Inhibition and Radiation in Children With Recurrent, Progressive or Refractory CNS Malignancies.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have a recurrent, progressive, or refractory central nervous system (CNS) malignancy without known curative options.
- Eligible tumor types include medulloblastoma, ATRT, high-grade gliomas, pineoblastomas, embryonal tumors NOS, CNS sarcomas, ependymomas, and other high-grade malignancies that failed first-line therapies.
- Patients should have received radiation as part of standard initial therapy.
- Patients must have received at least one line of standard care treatment.
- Evidence of clinical or radiological progressive disease as defined by RAPNO criteria.
- Patients with metastatic disease are eligible.
- Availability of archival or fresh tumor tissue for study.
- Patients aged 7 to under 22 years for the first 3 patients; thereafter, patients aged 3 to under 22 years.
- Recovery from all surgical interventions before starting radiation and maintenance phases.
- Body surface area of at least 0.6 m2.
- Recovery from acute effects of prior therapy.
- Last chemotherapy dose at least 2 weeks before starting SGT-53.
- Last biologic therapy dose more than 7 days before starting SGT-53.
- Eligible for hypofractionated radiation therapy based on clinical care standards.
- Stable or decreasing corticosteroid dose for at least 1 week before enrollment, with a maximum dexamethasone dose of 0.5 mg/m2/day.
- Last short-acting growth factor dose at least 1 week before treatment; last long-acting or pegylated growth factor dose at least 2 weeks before treatment.
- Neurological baseline stable for at least 1 week before enrollment.
- Performance status greater than 50 (Karnofsky or Lansky) within 2 weeks.
- Normal organ and marrow function as specified.
- Use of acceptable birth control during treatment and for 5 months after last dose for patients with childbearing or child-fathering potential.
- Female patients not pregnant or nursing and with negative pregnancy test at enrollment.
- Ability and willingness to provide informed consent.
You will not qualify if you...
- Low-grade glioma, craniopharyngioma, and other non-malignant CNS tumors.
- Diagnosis of diffuse midline gliomas (DMGs).
- Any serious unrelated systemic illness likely to interfere with study therapy or procedures.
- Pre-existing cardiac dysfunction with ejection fraction below 35%.
- Pre-existing pulmonary fibrosis, interstitial lung disease, or significant pulmonary disease.
- Receiving any other investigational drug therapy.
- Inability to adhere to protocol requirements.
- History of autoimmune diseases requiring treatment in the last 2 years.
- Live vaccine received within 30 days before study treatment.
- Known HIV/AIDS or acute/chronic Hepatitis B or C infection.
- Prohibited from receiving radiation therapy due to maximum lifetime dose reached.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of active treatment period as defined by the trial protocol
Participants receive combined treatment including SGT-53, nivolumab, and hypofractionated radiotherapy targeting recurrent, progressive, or refractory CNS malignancies.
Multiple visits for treatment administration and monitoring as scheduled by the study team
Duration - Up to 3 years from end of treatment
Participants are monitored for safety, toxicity, and preliminary efficacy for up to 3 years after the end of treatment.
Periodic visits for safety and efficacy assessments
Trial Site Locations
Total: 1 location
1
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
Research Team
J
Julia Batarseh
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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