NCT07346144

Study of an AAV Mediated Dual-Payload Gene Therapy in Patients With High Grade Glioma

A Phase I/II Study of an AAV-1 Mediated Dual-Payload Gene Therapy in Patients With High Grade Glioma

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Trogenix ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to first define the Safety and Optimal Biological Dose (OBD) of study drug TGX-007 and to then further investigate the safety and efficacy in patients with newly diagnosed or recurrent Glioblastoma. TGX-007 is a gene therapy drug delivered by a harmless adeno-associated virus (AAV) vector which delivers two combined therapeutic payloads to enable killing of proliferative cells and activation of an anti-tumour immune response. One is herpes simplex virus thymidine kinase (HSV-tk), which converts the pro-drug valaciclovir into an active drug that can kill tumour cells and the other is interleukin 12 (IL-12), which activates the body's immune system to recognise and fight the tumour. Patients newly diagnosed with glioblastoma suitable for standard of care surgery and chemoradiotherapy or patients with recurrent glioblastoma suitable for further surgery may be eligible for the study. Patients will receive TGX-007 by a direct intratumoural injection and will then take the pro-drug valacyclovir orally for up to 21 days before proceeding to standard of care surgery. The study is split into two phases. Phase I will treat patients at different dose levels of TGX-007 to identify the Optimal Biological Dose that will be used to further expand the study into Phase II. Phase II will expand the number of patients treated at the selected OBD to investigate how effective TGX-007 is at treating newly diagnosed and recurrent GBM. Approximately 68 people aged 18-70 will take part in the study.

Conditions

• Glioblastoma (GBM)
• High Grade Gliomas
• Recurrent Glioblastoma
• Newly Diagnosed Glioblastoma

Interventions

Type	Name	Description
DRUG	TGX-007	TGX-007 administered as single intratumoural injection
DRUG	Valaciclovir	Oral valaciclovir administered 3 times daily for 14 - 21 days

Timeline

• Start date: 2026-03-01
• Primary completion: 2030-03-01
• Completion: 2033-09-01
• First posted: 2026-01-16
• Last updated: 2026-03-04

Locations

2 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study