A Study of VRT106 in Combination With Radiotherapy in Adult Patients With Diffuse Midline Glioma / Diffuse Intrinsic Pontine Glioma

A Single-Arm, Open-Label, Multicenter Phase II Clinical Study of VRT106 in Combination With Radiotherapy in Adult Patients With Diffuse Midline Glioma / Including Diffuse Intrinsic Pontine Glioma

To Evaluate the Preliminary Efficacy and Safety/Tolerability of VRT106 Combined with Radiotherapy in Adult Patients with DMG/DIPG

This is a single-arm, open-label, multicenter Phase II study designed to assess the efficacy, safety, pharmacokinetic (PK) profile, and biological effects of VRT106 combined with radiotherapy in adult patients with newly diagnosed or progressive diffuse midline glioma (DMG) or diffuse intrinsic pontine glioma (DIPG).

Inclusion Criteria:

• Voluntary signing of the Informed Consent Form (ICF), indicating understanding of the study and willingness and ability to comply with all study procedures.
• Male or female adults aged 18 to 75 years at the time of signing the ICF.
• Histologically or cytologically confirmed H3 K27-altered diffuse midline glioma (DMG), or a diagnosis of DIPG based on brain contrast-enhanced MRI: tumor originating in the pons, occupying >50% of the pons volume, with diffuse brainstem enlargement.
• Karnofsky Performance Status (KPS) score ≥ 60.
• Expected survival time ≥ 3 months.

Exclusion Criteria:

• Individuals with extracranial metastases.
• Presence of spinal cord tumors or evidence of leptomeningeal disease dissemination.
• Active hemorrhage detected on cranial MRI scan prior to enrollment.
• Inability to undergo cranial MRI scanning (e.g., due to contraindications or incompatible implants).
• Prior receipt of oncolytic virus therapy or other gene therapy agents.