Study on Gene Therapy Using AAV for Patients with High-Grade Glioma

Sponsor: Trogenix ltd

Sponsor score: 0

ClinicalTrials ID:NCT07346144

Provider View

This clinical trial is testing a new gene therapy, TGX-007, to see if it is safe and effective for patients with newly diagnosed or returning glioblastoma, a type of brain cancer. The therapy uses a harmless virus to deliver two treatments directly to the tumor, aiming to kill cancer cells and boost the immune system.

Patient Parameters

Program Overview

The study aims to determine the safest and most effective dose of TGX-007, a gene therapy for glioblastoma, a type of brain cancer. TGX-007 is delivered using a harmless virus and contains two treatments: one that helps kill cancer cells and another that activates the immune system to fight the tumor. Patients will receive the therapy directly into the tumor and take an oral medication for up to 21 days before undergoing standard surgery. The study has two phases: Phase I will find the best dose, and Phase II will test its effectiveness in more patients. About 68 people aged 18-70 will participate.

Eligibility Criteria

Inclusion Criteria

  • Aged between 18 and 70 years old.
  • Good overall health with a performance status of 70 or higher.
  • For newly diagnosed patients: Have a single, high-grade glioma on one side of the brain.
  • For recurrent patients: Have a glioblastoma that has returned after initial treatment with surgery and chemoradiotherapy.
  • Suitable for standard treatment involving six weeks of chemoradiotherapy followed by six months of additional medication.
  • Surgery is recommended for the best care.
  • Able to take oral medication.
  • Willing to avoid live vaccines.
  • Have adequate organ function.
  • Women of childbearing potential must have a negative pregnancy test before starting the study.
  • Agree to use effective birth control or abstain from sex.
  • Willing and able to provide informed consent to participate in the study.

Exclusion Criteria

  • Pregnant, breastfeeding, or planning to become pregnant during the study.
  • Have an immune deficiency or active autoimmune disease needing treatment.
  • Have an active infection requiring treatment within 7 days of surgery.
  • Received a live vaccine within 28 days before starting the study.
  • Using immunosuppressive or immune-modulating drugs within 28 days before starting the study.
  • History of tuberculosis or evidence of past infection on chest imaging.
  • Previously treated with gene therapy.
  • Have a significant central nervous system disorder that could affect participation.
  • Major surgery within 28 days before starting the study (except for a biopsy).
  • Allergic to valaciclovir, gadolinium, or components of TGX-007.
  • Cannot undergo MRI with gadolinium.
  • Any condition that could interfere with surgery timing.
  • Had another cancer within the last 3 years, except for certain treated skin, cervical, or prostate cancers.
  • Any other significant health issue that could affect participation or study results.
  • Participated in another investigational study within the last 12 weeks.
  • Any personal or logistical issues that could affect compliance with the study.
  • Unwilling to inform their general practitioner about study participation.

For newly diagnosed patients only:

  • Any prior treatment for glioma.
  • Planned use of tumor treating fields.

For recurrent patients only:

  • Unresolved side effects from previous cancer treatments.
  • Planned use of tumor treating fields.

Locations

FACILITYZIPCITYSTATE
Ohio State University Hospital43210ColumbusOhio

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