NCT07472790

A Study on the Novel Oncolytic Virus Combined With PD-1 Inhibitor in the Treatment of Recurrent High-grade Glioma

A Single-arm Clinical Study on the Efficacy and Safety of the Novel Oncolytic Virus Ad-TD-nsIL12 Combined With PD-1 Inhibitor in the Treatment of Recurrent High-grade Glioma

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Beijing Bio-Targeting Therapeutics Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A single-arm clinical study on the efficacy and safety of the novel oncolytic virus Ad-TD-nsIL12 combined with PD-1 inhibitors in the treatment of recurrent high-grade glioma

Detailed description

This study is a single-arm, single-center, exploratory clinical trial evaluating the preliminary efficacy and safety of the oncolytic virus Ad-TD-nsIL12 in combination with a PD-1 inhibitor for the treatment of recurrent HGG. It is planned to enroll 12-15 HGG patients and use a treatment regimen of Ad-TD-nsIL12 combined with a PD-1 inhibitor to preliminarily assess the efficacy and safety of this regimen.

Conditions

• High-grade Glioma

Interventions

Type	Name	Description
BIOLOGICAL	Novel oncolytic virus Ad-TD-nsIL12（BioTTT001）	Inject Ad-TD-nsIL12 into the tumor via Ommaya reservoir, administering on days 1, 4, and 7, and infuse a PD-1 inhibitor on day 9.Ad-TD-nsIL12 is injected every 21 days (± 3 days) as appropriate in subsequent cycles. On the 7th day (±3 days) after oncolytic virus administration each cycle, a PD-1 inhibitor is given, or until disease progression or the occurrence of intolerable toxicity.

Timeline

• Start date: 2026-03-31
• Primary completion: 2028-04-30
• Completion: 2028-04-30
• First posted: 2026-03-16
• Last updated: 2026-03-16

Locations

1 site across 1 country: China