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NCT07589257
A Study of VRT106 in Combination With Radiotherapy in Adult Patients With Diffuse Midline Glioma / Diffuse Intrinsic Pontine Glioma
Conditions: Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Intrinsic Pontine Glioma
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 10
Sponsor: Guangzhou Virotech Pharmaceutical Co., Ltd.
Location: Sun Yat-sen University Cancer Center Guangzhou Guangdong
Summary
To Evaluate the Preliminary Efficacy and Safety/Tolerability of VRT106 Combined with Radiotherapy in Adult Patients with DMG/DIPG
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07589257). StuddyBuddy aggregates publicly available trial information.