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Oncolytic Virus Ad-TD-nsIL12 for Progressive Pediatric Diffuse Intrinsic Pontine Glioma
Sponsor: Capital Medical University
Summary
This is a single-arm, single-center, 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 progressive DIPG patients (NCI-CTCAE V5.0).
Key Details
Gender
All
Age Range
1 Year - 18 Years
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2023-01-04
Completion Date
2028-01-04
Last Updated
2024-02-28
Healthy Volunteers
No
Interventions
Ad-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 3days). 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