CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 18 target
Drug / intervention
Ad-TD-nsIL12biological
Likely dose
Ad-TD-nsIL12 1 mlfrom record
Key inclusion· 6
  • ✓Newly diagnosed DIPG confirmed on MRI
  • ✓Age 1-18 years
  • ✓Lesion accessible for stereotactic biopsy without entering ventricular system
  • ✓No previous treatment for DIPG
Key exclusion· 9
  • ✕Serious infections or intercurrent conditions (severe renal, liver, heart, or bone marrow failure)
  • ✕Immunodeficiency, autoimmune disease, or active hepatitis
  • ✕Tumor with multiple locations
  • ✕Pregnant or breast-feeding females

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05717712
NCT05717712Phase 1RecruitingUpdate OverdueUpdated 28mo ago · Completion was 17mo ago
Enrollment Stalled
Long Recruiting
Update Overdue
CompareCT.gov

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

Capital Medical University·interventional·Posted Feb 8, 2023·Updated Feb 28, 2024

In Brief

A Phase 1 clinical trial evaluating Ad-TD-nsIL12 for Oncolytic Virus and 2 related conditions. Currently recruiting, targeting 18 participants across 1 site.

Signals

Enrollment appears stalled

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOncolytic Virus, Diffuse Intrinsic Pontine Glioma, Adverse Drug Event
CountriesChina
Collaborators--

Timeline

Phase 1Recruiting
202320242025202620272028
First PostedFeb 8, 2023
Enrollment StartJan 4, 2023
Primary CompletionJan 4, 2025
Study CompletionJan 4, 2028
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 3.4 years ago

Interventions

Ad-TD-nsIL12biological

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.