ADePT-PI/II study of AAV-1Dual-Payload gene Therapy for high grade glioma
Research type
Research Study
Full title
ADePT - A Phase I/II study of an AAV-1 mediated Dual-Payload gene Therapy in patients with high grade glioma
IRAS ID
1010416
Contact name
Bryn Dixon
Contact email
Sponsor organisation
Trogenix Ltd
Research summary
Glioblastoma (GBM) is the most common and most aggressive brain tumour and remains incurable despite trimodality treatment (surgery, chemoradiotherapy, adjuvant chemotherapy) due to the persistence of cancer cells within the brain that cannot be surgically removed (termed residual disease).
Trogenix has developed a new gene therapy treatment called TGX-007 that both kills GBM cancer cells and activates a patient’s immune system against the disease. Using a new technology that controls the way genes are switched on in cells, TGX-007 specifically targets tumour cells and not surrounding healthy brain cells. TGX-007 is made up of a harmless virus that is injected directly into the tumour itself and is able to infect the cells. These genes only activate within the tumour and do not activate in healthy tissue which means TGX-007 can maximise tumour cell killing whilst minimising unwanted side effects.
The ADePT study will enrol patients with either newly diagnosed GBM or patients whose GBM has come back for the first time following initial treatment. Eligible patients will have the TGX-007 infused directly into the brain tumour via a needle which allows for very precise treatment delivery using a process called Convection Enhanced Delivery (CED). Patients will take a companion drug tablet that is activated by one of the genes delivered by TGX-007 and needed to kill the cancer. They will take these tablets for between 2 and 3 weeks (depending on the exact date of their surgery) which is expected to give TGX-007 time to work. All patients will then go on to have as much of their tumour as possible removed via surgery and have further 'standard of care' treatment (ie the treatment they would receive normally, if not participating in the trial). The goal of the study is to test the safety of TGX-007 and gather information about whether the drug is effective at treating GBM. The study is being funded by Trogenix and is taking place at hospitals in the UK and in the US.REC name
North East - York Research Ethics Committee
REC reference
25/NE/0178
Date of REC Opinion
21 Jan 2026
REC opinion
Further Information Favourable Opinion