Back to search results

Study of TGX-007 for High-Grade Glioma

This study is testing a new gene therapy called TGX-007 for people with newly diagnosed or recurrent glioblastoma (a type of brain cancer) and other high-grade gliomas. TGX-007 is given as a single injection into the tumor, along with an oral medication called valaciclovir. The gene therapy works by delivering two treatments: one that helps kill tumor cells and another that activates your body's immune system to fight the cancer. The main goals are to find a safe and effective dose of TGX-007 and to see how long people live after treatment. You might be able to join if you are between 18 and 70 years old and have a good performance status. The current status of this study is unclear.

Study design
This study plans to enroll 68 participants. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
Participants will receive a single injection of TGX-007 and take oral valaciclovir daily for 14-21 days. The study will monitor your safety for at least 28 days after the TGX-007 injection.
Compensation
Not stated in the trial record.
Follow-up
Participants with newly diagnosed high-grade glioma will be followed for overall survival for up to 18 months. Participants with recurrent glioblastoma will be followed for overall survival for up to 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07346144

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

Recruiting
PHASE1Ages 18–70InterventionalTreatment
Trogenix ltd
~68 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:TGX-007Valaciclovir

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and tolerability of TGX-007 when administered to patients with newly diagnosed HGG or recurrent GBM and to identify the OBD
Measured over Day 0 (TGX-007 injection) to 28 days post administration of TGX-007
+1 more outcome measured

Conditions

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

Explore related trials

GlioblastomaMalignant Glioma

Where it's being run

2 sites across 2 states
Ohio1
United Kingdom1

Who to contact

Project Management
[email protected]
+44131 287 5960
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Aged 18-70 years
Karnofsky performance status ≥70
Newly diagnosed patients: Unifocal, unilateral high-grade glioma based on MRI
Recurrent patients: First radiological progression (as determined by the multidisciplinary team \[MDT\]) of GBM previously treated with standard care surgery and chemoradiotherapy. Patients must have a prior confirmed histological/molecular diagnosis of GBM
Newly diagnosed patient: suitable for six weeks of chemoradiotherapy followed by six months of adjuvant temozolomide (Stupp protocol)
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 to use highly effective contraception
Patient is willing and able to give informed consent for participation in the study

Exclusion

Patient who is pregnant, lactating or planning pregnancy during the course of the study
Immunodeficiency or active auto-immune disease requiring systemic therapy.
Active viral, bacterial or fungal infection requiring concurrent antivirals or antibiotics within 7 days of surgery
Live vaccine within 28 days prior to Day 0
Use of immunosuppressant or immune modulatory medicines within 28 days prior to Day 0
History of tuberculosis infection or chest x-ray or computed tomography (CT) chest showing radiological evidence of previous tuberculosis infection
Received previous treatment with a gene therapy
Significant history of a central nervous system disorder that, in the opinion of the Investigator, would preclude enrolment
Major surgery within 28 days prior to Day 0. A stereotactic biopsy is permitted
Known hypersensitivity or contraindications to valaciclovir, gadolinium, or any excipients for TGX-007
Contraindication to MRI with gadolinium
Any condition expected to interfere with the intended timing of debulking surgery
Previous non-glioma cancer within 3 years (other than treated squamous/basal cell skin cancer, treated early-stage cervical cancer or treated/biochemically stable, organ confined prostate cancer)
Any other significant disease or disorder which, in the opinion of the Investigator, may put the patient at risk because of participation in the study or may influence the results of the study or the patient's ability to participate in the study
Patients who have participated in another research study involving an investigational product in the past 12 weeks or 5 half-lives of the product
Any psychological, familial, sociological, or geographical consideration potentially hampering compliance with the study protocol and follow up schedule; these conditions should be discussed with the patient before registration in the study
Unwilling to allow their general practitioner, if appropriate, to be notified of participation in the study
Any prior therapy for glioma
Intended use of tumour treating fields
Prior toxicities from anti-cancer agents or radiotherapy which have not recovered to ≤Grade 1 severity
Intended use of tumour treating fields

What this trial measures

  • Safety and tolerability of TGX-007 when administered to patients with newly diagnosed HGG or recurrent GBM and to identify the OBDDay 0 (TGX-007 injection) to 28 days post administration of TGX-007

    Incidence of AEs/SAEs, incidence of DLT within 28 days of TGX-007 administration at each dose level, and incidence of HSV-tk mRNA expression, or equivalent, in tissue

  • Overall Survival rate of patients with newly diagnosed HGG or recurrent GBM treated with TGX-007Day 0 (TGX-007 injection) to 18 months (newly diagnosed); Day 0 (TGX-007 injection) to 6 months (recurrent patients)

    Overall Survival at 18 months (newly diagnosed patients) and 6 months (recurrent patients).