NCT06193538招募中1 期
Clinical Study on the Safety and Effectiveness of NV-A01 in the Treatment of Advanced Glioma Patients
First Affiliated Hospital of Wannan Medical College1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年9月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Safety and Tolerabilityof NV-A01 in the treatment of advanced glioma patients as measured by Frequency of Grade 3 or Above Adverse Events
研究概览
简要总结
The goal of this clinical trial is to learn about the safety and effectiveness of NV-A01 in the treatment of advanced glioma patients. The main questions it aims to answer are:
- The safety of NV-A01 in the treatment of advanced glioblastoma patients.
- The effectiveness of NV-A01 in treating patients with advanced glioblastoma.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with advanced malignant glioma confirmed by histopathology;
- •Patients who have received radiotherapy and/or temozolomide (TMZ) treatment and have residual or recurrent tumors;
- •Patients diagnosed with lesions ≥ 1.0 cm after qualified assessment;
- •KPS score ≥ 60 points;
- •The subjects had informed consent to this study before the experiment and voluntarily signed an informed consent form.
排除标准
- •Patients with unstable central nervous system metastases or meningeal metastases with clinical symptoms, with a risk of brain herniation or severe brain herniation, and judged by researchers as unsuitable for inclusion;
- •Patients with severe cardiovascular diseases, active autoimmune diseases, and other diseases that have been determined by researchers to be unsuitable for enrollment;
- •Patients who have received immunotherapy in the past and have an irAE level ≥ 3, and have been determined by the researchers to be unsuitable for enrollment;
- •Patients with an expected survival period of less than 3 months and judged by the researchers as unsuitable for enrollment;
- •Researchers believe that patients with other serious systemic diseases or other reasons are not suitable for participating in this clinical study.
研究组 & 干预措施
Intratumoral injection of NV-A01 adenovirus
Experimental
干预措施: Recombinant NV-A01 adenovirus injection (Drug)
结局指标
主要结局
Safety and Tolerabilityof NV-A01 in the treatment of advanced glioma patients as measured by Frequency of Grade 3 or Above Adverse Events
时间窗: One months after the last injection
All events with a Grade 3 or above toxicity (defined by the NCI-CTCAE 5.0) will be tabulated by event and by relationship to NV-A01.
次要结局
- Evaluate the effectiveness of NV-A01 in treating patients with advanced glioblastoma(Six months after the last injection)
- Developing pharmacodynamic indicators Discovering pharmacodynamic indicators Discovering pharmacodynamic indicators(Six months after the last injection)
研究者
Jiang Xiao-chun
Professor
First Affiliated Hospital of Wannan Medical College
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Pilot Clinical Study of NOA-001 for ARDS (Acute Respiratory Distress Syndrome)Acute Respiratory Distress SyndromeNCT04804943Toray Industries, Inc45
已完成
不适用
A-MAV™ Anterior Motion Segment ReplacementSpinal DiseasesNCT00635934Medtronic Spinal and Biologics53
招募中
不适用
A Registry Study of Intracranial Atherosclerotic Stenosis Treatment by Intracranial Drug-eluting Stenting in ChinaIntracranial ArteriosclerosisStenosis ArteryDrug-Eluting StentsIntracranial Artery StenosisNCT05692882Sino Medical Sciences Technology Inc.1,000
招募中
不适用
A Prospective, Trial About Safety and Efficacy of Combined Treatment With Cerebrolysin in Acute Ischemic Hemispheric Stroke Patients Undergoing EndoVascular Treatment (EVT)Acute Ischemic StrokeNCT06070753Shaare Zedek Medical Center30
尚未招募
4 期
The Possible Efficacy and Protective Effect of Empagliflozin in Rheumatoid Arthritis Patients Treated with MethotrexateRheumatoid Arthritis (RA)Methotrexate Induced NephrotoxicityMethotrexate Adverse ReactionNCT06641128Tanta University44