RecruitingPhase 1NCT05717712

Oncolytic Virus Ad-TD-nsIL12 for Primary Pediatric Diffuse Intrinsic Pontine Glioma


Sponsor

Capital Medical University

Enrollment

18 participants

Start Date

Jan 4, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a drug safety assessment clinical trial with a 3+3 dose escalation design, to observe the safety, tolerability and toxicity of a novel oncolytic virus Ad-TD-nsIL12 intratumoral injection in primary DIPG patients (NCI-CTCAE V5.0).


Eligibility

Min Age: 1 YearMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a specially engineered virus (Ad-TD-nsIL12), injected directly into newly diagnosed diffuse intrinsic pontine glioma (DIPG) tumors in children, can stimulate the immune system and fight the cancer. This is an early-phase trial assessing safety and initial effectiveness for children who have not yet received any treatment. **You may be eligible if...** - Your child is between 1 and 18 years old - Your child has a newly diagnosed DIPG on MRI and has not received any treatment for it yet - Your child is functional enough to participate (performance score of 50 or above) - The tumor is accessible for a precise stereotactic biopsy and injection **You may NOT be eligible if...** - Your child has had any prior treatment for DIPG - Your child has a serious infection, immune deficiency, autoimmune disease, or active hepatitis - Your child has a tumor in multiple separate locations - Your child has Li-Fraumeni syndrome or certain inherited cancer-predisposing genetic conditions - Your child's blood counts or organ function are significantly abnormal Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAd-TD-nsIL12

After stereotactic biopsy, the Ommaya reservoir will be inserted through the biopsy channel and two injections of Ad-TD-nsIL12 will be delivered after surgery by Ommaya reservoir (with an interval of 3 days). The interval between following injections in the subsequent treatment period will be 3 weeks ±4 days. The assigned dose for each patient will be 3x10\^9vp, 1x10\^10vp or 3x10\^10 vp suspended in 1 ml NS according to cohort design.


Locations(1)

Sanbo Brain Hospital, Capital Medical University

Beijing, Beijing Municipality, China

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NCT05717712


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