Phase III Study of TGX-007 Gene Therapy Delivered by AAV-1 for Adults with Newly Diagnosed or Recurrent High Grade Glioma

What this Trial Is About

Researchers are studying TGX-007, a gene therapy drug delivered by a harmless virus, in patients with newly diagnosed or recurrent glioblastoma, a type of high-grade brain tumor. The trial aims to determine the safest and most effective dose of TGX-007 and then evaluate its safety and how well it works in these patients. This study is conducted in two phases a dose-finding phase followed by an expansion phase to further assess treatment effects. Participants will receive a single direct injection of TGX-007 into the tumor, followed by oral doses of the pro-drug valaciclovir taken three times daily for up to 21 days. After this treatment, patients will undergo standard surgery and chemoradiotherapy according to current care guidelines. The study includes groups for dose escalation and expansion in both newly diagnosed and recurrent glioblastoma patients, with about 68 participants aged 18 to 70. During the trial, participants will be closely monitored for safety and treatment effects. Assessments include survival rates up to five years, tumor progression, viral shedding in body fluids, and response to therapy. Researchers will evaluate side effects and tolerability from the day of TGX-007 injection through the follow-up period. The study involves regular evaluations and laboratory tests to track outcomes and ensure participant safety throughout the study duration.

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