NCT07589257招募中2 期
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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
研究概览
简要总结
To Evaluate the Preliminary Efficacy and Safety/Tolerability of VRT106 Combined with Radiotherapy in Adult Patients with DMG/DIPG
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •Expected survival time ≥ 3 months.
排除标准
- •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.
研究者
研究点 (1)
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