Actively Recruiting
A Phase I/II Study of an AAV-1 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
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and best dose of TGX-007, a gene therapy drug, in patients with newly diagnosed or recurrent glioblastoma, a type of high-grade brain tumor. TGX-007 uses a harmless virus to deliver two treatments: one kills tumor cells when activated by another drug, and the other helps the immune system fight the tumor. The study aims to understand how well TGX-007 works and how safe it is for these patients. Participants will receive TGX-007 through a direct injection into the tumor, followed by oral treatment with valaciclovir, the drug that activates part of the gene therapy, for up to 21 days before undergoing standard surgery. The study has two phases: Phase I tests different doses to find the optimal biological dose, and Phase II treats more patients at this dose to evaluate effectiveness in both newly diagnosed and recurrent glioblastoma cases. During the study, patients will be closely monitored for safety and treatment effects through various assessments over time, including survival rates up to 18 months for new patients and 6 months for recurrent cases. Additional follow-up will continue for up to five years to track overall survival, tumor progression, response to treatment, and possible viral shedding. The total participation spans from initial treatment through extended follow-up to ensure detailed evaluation of safety and outcomes.
CONDITIONS
Brief 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 of 70 or higher
- 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 surgery and chemoradiotherapy, with confirmed histological/molecular diagnosis
- Newly diagnosed patients must be suitable for six weeks of chemoradiotherapy followed by six months of adjuvant temozolomide (Stupp protocol)
- Debulking surgery is indicated for optimal care
- Able to swallow oral medication
- Willing to avoid live vaccines
- Adequate organ function
- Female patients of childbearing potential must have a negative pregnancy test within 7 days prior to treatment
- All patients must agree to practice true abstinence or use highly effective contraception
- Willing and able to give informed consent
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 antivirals or antibiotics within 7 days of surgery
- Live vaccine within 28 days prior to treatment
- Use of immunosuppressants or immune modulatory medicines within 28 days prior to treatment
- History or radiological evidence of tuberculosis infection
- Previous treatment with gene therapy
- Significant central nervous system disorder precluding enrollment
- Major surgery within 28 days prior to treatment, except stereotactic biopsy
- Known allergy or contraindication to valaciclovir, gadolinium, or TGX-007 components
- Contraindication to MRI with gadolinium
- Any condition that may interfere with timing of surgery
- Previous non-glioma cancer within 3 years (with exceptions)
- Other significant diseases that may risk participation or affect results
- Participation in another investigational study within past 12 weeks
- Psychological, familial, sociological, or geographical factors that may hamper compliance
- Unwillingness to notify general practitioner of participation
- Newly diagnosed patients must have no prior glioma therapy or intended use of tumor treating fields
- Recurrent patients must have recovered from prior toxicities and no intended use of tumor treating fields
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 weeks
Participants receive a single intratumoural injection of TGX-007 followed by oral valaciclovir taken three times daily for 14 to 21 days.
1 injection visit and daily medication for up to 21 days
Duration - Up to 5 years
Participants are monitored for safety, tolerability, viral shedding, and overall survival for up to 5 years after treatment.
Regular follow-up visits over several years
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
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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