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RECRUITING
NCT05717699
PHASE1

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

Sponsor: Capital Medical University

View on ClinicalTrials.gov

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

BIOLOGICAL

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