NCT02771301Unknown不适用
Safety and Efficacy of IDH1R132H-DC Vaccine in Gliomas
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Safety and Efficacy of IDH1R132H dendritic cell vaccine as measured by adverse events
研究概览
简要总结
This trial is aimed at evaluating the safety and efficacy of IDH1R132H-DC vaccine in glioma with IDH1R132H mutation.
详细描述
Eligible patients that provide written informed consent will undergo apheresis to collect blood mononuclear cells for vaccine production. All patients will receive mature dendritic cells for a total of 12 vaccine doses.The DC vaccine will be given subcutaneously every four weeks. Peripheral blood will be taken two weeks after injection each time to monitor the immune response.
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
- •The patient signed "informed consent" voluntarily;
- •The age of patient is between 18 and 70 years;
- •The tumor can be resected and tumor resection rate ≥80%;
- •IDH1R132H mutation can be confirmed by immunohistochemistry or real-time quantitative PCR;
- •Peripheral blood lymphocytes absolute value is not less than 0.8 × 106;
- •KPS score ≥70 ;
- •The patient has normal bone marrow reserve and normal liver and kidney function ( The bone marrow, liver and kidney function must be confirmed by Laboratory examination to meet the requirements of participating in the study within 3 days before the first acceptance of IDH1R132H-DC tumor vaccine therapy): Medium neutrophil absolute value ≥1,500 / mm3; hemoglobin> 10g / dL; platelet count> 100,000 / mm3; total bilirubin <1.5 × ULN; alanine aminotransferase / aspartate aminotransferase <2.5 × ULN; serum creatinine <1.5 × ULN;
- •Normal heart function ;
- •Better follow-up and compliance;
- •For women of childbearing age (15 to 49 years)，pregnancy test must be negative 7 days before starting this study. Male and female patients of childbearing potential must agree to use effective contraceptive measures to ensure that during the study period and three months after cessation of treatment will not be pregnant.
排除标准
- •The patient did not sign "informed consent" or signed unvoluntarily.
- •Non-glioma patients
- •Drugs for brain or antibody therapy had been used 4 weeks before the start of this study
- •Active infection
- •Human immunodeficiency virus (HIV) positive
- •Hepatitis C or hepatitis B infective
- •Pregnancy or breast-feeding women
- •Patients did not agree to use effective contraception during treatment and the following 3 months.
- •Patients also participated in other clinical studies.
- •The subjects researchers believe are not suitable for participation or completion of the study.
结局指标
主要结局
Safety and Efficacy of IDH1R132H dendritic cell vaccine as measured by adverse events
时间窗: 2 year
2 years progress free survival and overall suvival as measured by RECIST criteria 4.0
次要结局
- Antigen specific cell responses before and after vaccination(2 year)
研究者
Nan Ji
Professor of Neurosurgery
Beijing Tiantan Hospital
研究点 (2)
Loading locations...
相似试验
Unknown
1 期
Safety Study of DIPG Treatment With Autologous Dendritic Cells Pulsed With Lysated Allegenic Tumor LinesDiffuse Intrinsic Pontine GliomaNCT02840123Fundació Sant Joan de Déu10
已完成
不适用
Clinical Evaluation of Genetron IDH1 PCR Kit in Glioma PatientsGlioma, MalignantGlioma, MixedNCT05100173Genetron Health1,192
已完成
1 期
AMPLIFYing NEOepitope-specific VACcine Responses in Progressive Diffuse GliomaMalignant GliomaNCT03893903German Cancer Research Center69
撤回
2 期
Trial of IDH305 in IDH1 Mutant Grade II or III GliomaGliomaNCT02977689NYU Langone Health
Unknown
不适用
Non Invasive Detection of IDH1/2 Mutation in GliomasIDH1/IDH2 MutationGliomaNCT02597335Assistance Publique - Hôpitaux de Paris40