- Study of an AAV Mediated Dual-Payload Gene Therapy in Patients With High Grade Glioma — Recruiting • Phase I • Oncology • NCT07346144.
- Sponsor: Trogenix ltd.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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…
- : * 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.