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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Trogenix ltd
Study ID
NCT07346144
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • TGX-007 — DRUG
    TGX-007 administered as single intratumoural injection
  • Valaciclovir — DRUG
    Oral valaciclovir administered 3 times daily for 14 - 21 days

Study Details

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.

Key Dates

Start date
Apr 21, 2026
Status verified
Apr 2026
Primary completion
Mar 31, 2030
Completion
Sep 30, 2033

Study Design

Enrollment
68 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Finding
    Dose escalation (with dose levels -1, 1, 2)
  • Experimental: Newly Diagnosed Expansion
    Expansion in Newly Diagnosed High Grade Glioma patients at the Optimal Biological Dose.
  • Experimental: Recurrent Glioblastoma Expansion
    Expansion in recurrent glioblastoma patients at the Optimal Biological Dose.

Primary Outcome Measure

Safety and tolerability of TGX-007 when administered to patients with newly diagnosed HGG or recurrent GBM and to identify the OBD [ Time Frame: Day 0 (TGX-007 injection) to 28 days post administration of TGX-007 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University HospitalColumbusOhio43210-

Find similar trials in Columbus, OH

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Ohio State University Hospital· Columbus, OH

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