Safety and Efficacy of IDH1R132H-DC Vaccine in Gliomas

Study Overview
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Brief Summary
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This trial is aimed at evaluating the safety and efficacy of IDH1R132H-DC vaccine in glioma with IDH1R132H mutation.

Detailed Description
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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.

Official Title
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Safety and Efficacy of IDH1R132H-DC Vaccine in Gliomas

Conditions
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Glioma

Intervention / Treatment
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* Biological: dendritic cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: dendritic cell<br>Patients will receive autolgous IDH1R132H dendritic cells and cytotoxic lymphocytes treatment. | Biological: dendritic cells<br>* Concurrent of radiotherapy and chemotherapy plus 12 cycles of dendritic cells and cytotoxic lymphocytes treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Efficacy of IDH1R132H dendritic cell vaccine as measured by adverse events | 2 years progress free survival and overall suvival as measured by RECIST criteria 4.0 | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antigen specific cell responses before and after vaccination | Immunological response based on measuring increased numbers of IDH1R132H specific T cells and levels of anti-IDH1R132H antibody. | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IDH1R132H Dendritic cell glioma