Actively Recruiting
Study of an AAV Mediated Dual-Payload Gene Therapy in Patients With High Grade Glioma
Led by Trogenix ltd · Updated on 2026-05-04
68
Participants Needed
2
Research Sites
384 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of an AAV Mediated Dual-Payload Gene Therapy in Patients With High Grade Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18-70 years
- Karnofsky performance status 60
- Newly diagnosed patients must have unifocal, unilateral high-grade glioma based on MRI
- Recurrent patients must have first radiological progression of glioblastoma previously treated with standard care surgery and chemoradiotherapy
- Newly diagnosed patients must be suitable for six weeks of chemoradiotherapy followed by six months of temozolomide
- Debulking surgery is indicated for optimal patient care
- Able to swallow oral medication
- Willing to avoid live vaccines
- Adequate organ function
- Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to Day 0
- All patients must agree to practice true abstinence or use highly effective contraception
- Willing and able to give informed consent for participation in the study
You will not qualify if you...
- Pregnant, lactating, or planning pregnancy during the study
- Immunodeficiency or active autoimmune disease requiring systemic therapy
- Active viral, bacterial, or fungal infection requiring treatment within 7 days of surgery
- Received live vaccine within 28 days prior to Day 0
- Use of immunosuppressant or immune modulatory medicines within 28 days prior to Day 0
- History or radiological evidence of tuberculosis infection
- Previous treatment with gene therapy
- Significant central nervous system disorder precluding enrolment
- Major surgery within 28 days prior to Day 0 (except stereotactic biopsy)
- Known hypersensitivity or contraindications to valaciclovir, gadolinium, or TGX-007 excipients
- Contraindication to MRI with gadolinium
- Any condition expected to interfere with timing of debulking surgery
- Previous non-glioma cancer within 3 years (with some exceptions)
- Other significant diseases or disorders posing risk or affecting participation
- Participation in another investigational study within 12 weeks or 5 half-lives of the product
- Psychological, familial, sociological, or geographical factors hampering compliance
- Unwillingness to notify general practitioner of study participation
- Newly diagnosed patients: any prior therapy for glioma or intended use of tumor treating fields
- Recurrent patients: unresolved toxicities from prior cancer treatments or intended use of tumor treating fields
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Ohio State University Hospital
Columbus, Ohio, United States, 43210
Not Yet Recruiting
2
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom
Actively Recruiting
Research Team
P
Project Management
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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