This trial is aimed at evaluating the safety and efficacy of IDH1R132H-DC vaccine in glioma
with IDH1R132H mutation.
Biological: dendritic cells
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT02771301
Ages eligible for Study
18 Years to 70 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
The patient did not sign "informed consent" or signed unvoluntarily.
Drugs for brain or antibody therapy had been used 4 weeks before the start of this study
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.
All locations for NCT02771301
Beijing Tiantan Hospital
Beijing, Beijing, China, 100000
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Hebei Yanda Hospital
Sanhe, Hebei, China, 065200
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View full eligibility
Tris trial is registered with FDA with number: NCT02771301. The sponsor of the trial is Hebei Yanda Hospital and it is looking for 30 volunteers for the current phase.
Official trial title: Safety and Efficacy of IDH1R132H-DC Vaccine in Gliomas
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