IRCT20170122032121N7招募中2 期
Efficacy of the intrathecal injection of activated allogeneic natural killer cells in patients with High-grade gliomas; A multi-center phase II clinical trial
Kian immune cell company0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 3 years 至 60 years（—）
- 性别
- All
入选标准
- •New diagnosed patients with grade 3 or 4 brain tumor, based on WHO classification, which are included in the one of the following conditions: • Astrocytoma, IDH-mutant • Oligodendroglioma, IDH-mutant • Glioblastoma, IDH-wild type • Diffuse midline glioma • Diffuse hemispheric glioma • Diffuse pediatric-type high-grade glioma, IDH-wild type
- •Age range of 3 to 60 years old
- •Lansky/Karnofsky performance score above 60
- •Obtained informed consent of patients or parents or legal attendance in cases of pediatrics
- •Hemoglobin above 10 gr/dL of blood
- •Absolute granulocyte count (AGC) above 500 per microliter of blood
- •Platelet count above 50000 per microliter of blood
- •INR below 2 and PTT less than 1.5 times of maximum normal value
- •Plasma bilirubin level less than 1.5 times of maximum normal value
- •Plasma hepatic transaminases (ALT and AST) level less than 3 times of maximum normal value
- •Plasma creatinine level less than 1.5 times of maximum normal value
排除标准
- •Evidence of radio necrosis in MRI or MRS
- •Intolerance of new treatment due to emergency condition
- •History of other malignancies
- •History of any immunodeficiency diseases or any immune compromising conditions
- •Rupture of cerebral shunt or unable to perform a lumbar puncture
- •History of uncontrolled chronic diseases such as: Diabetes, CHF, liver cirrhosis, CKD, etc.
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