NCT03423992Unknown1 期
A Pilot Study to Evaluate the Safety and Efficacy of Personalized Chimeric Antigen Receptor T Cell Immunotherapy for Patients With Recurrent Malignant Gliomas Based on the Expression of Tumor Specific/Associated Antigens
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Adverse events attributed to the administration of the chimeric antigen receptor T cells
研究概览
简要总结
A pilot study to determine the safety and efficacy of chimeric antigen receptor T cell (autologous T cells transduced with a lentiviral vector expressing chimeric antigen receptor with or without anti-PDL1 antibody) personalized immunotherapy for patients with recurrent malignant gliomas based on the expression of tumor specific/associated antigens (EGFRVIII, IL13Rα2, Her-2, EphA2, CD133, GD2).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary informed consent for entry of trial;
- •Age greater than 18 years, and less than 70 years;
- •Pathologically confirmed recurrent malignant gliomas;
- •Tumor cells from resected tissue must be available for antigen testing (EGFRvIII, IL13Rα2, Her-2, CD133, EphA2, GD2) and at least one of the targets should be tested positively by immunohistochemistry study;
- •If the patient is on dexamethasone, the anticipated dose must be 4 mg/day or less for at least 5 days prior to apheresis.
- •Patients must have a Karnofsky performance status of greater than or equal to
- •Life expectancy greater than 3 months;
- •Participants with adequate organ function as measured by:
- •White blood count greater than or equal to 2500/mm^3; platelets greater than or equal to 100,000/mm^3, hemoglobin greater than or equal to 10.0 g/dL; without transfusion or growth factor support
- •Aspartate transaminase (AST), Alanine transaminase (ALT), gamma glutamyl transpeptidase (GGT), lactic acid dehydrogenase (LDH), alkaline phosphatase within 2.5 x upper normal limit, and total bilirubin less than or equal to 2.0 mg/dL
- •Serum creatinine less than or equal to 1.5 x upper limit of normal
- •Coagulation tests prothrombin time (PT) and partial thromboplastin time (PTT) have to be within normal limits, unless the patient has been therapeutically anti-coagulated for previous venous thrombosis.
排除标准
- •Female subjects of reproductive potential who are pregnant or lactating;
- •Previous treatment with any gene therapy products or other form immunotherapy;
- •Uncontrolled active infection.
- •Active or latent chronic hepatitis B [detectable hepatitis B surface antigen (HBsAg)] or active hepatitis C (positive serology [hepatitis C virus Ab]) infection.
- •HIV infection;
- •History of allergy or hypersensitivity to study product excipients (human serum albumin, Dimethyl sulfoxide, and Dextran 40);
- •Currently enrolled in other clinical trials;
结局指标
主要结局
Adverse events attributed to the administration of the chimeric antigen receptor T cells
时间窗: 1 year
Determine the toxicity profile of the chimeric antigen receptor T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
次要结局
- Objective Response Rate(1 year)
- clinical activity of chimeric antigen receptor T cells(28 days)
研究者
Qingtang Lin
Associate Professor, Department of Neurosurgery
Xuanwu Hospital, Beijing
研究点 (2)
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