Safety and Efficacy of IDH1R132H-DC Vaccine in Gliomas

Not Applicable

• Conditions: Glioma
• Interventions: Biological: dendritic cells

• Registration Number: NCT02771301
• Lead Sponsor: Hebei Yanda Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2016-02
• Status Verified: 2016-05
• Study First Submitted: 2016-05-10
• Study First Submitted QC: 2016-05-11
• Last Update Submitted: 2016-05-11
• Study First Posted: 2016-05-13
• Last Update Posted: 2016-05-13
• Primary Completion: 2019-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dendritic cell	dendritic cells	Patients will receive autolgous IDH1R132H dendritic cells and cytotoxic lymphocytes treatment.

Primary Outcome Measures

Name	Time	Method
Safety and Efficacy of IDH1R132H dendritic cell vaccine as measured by adverse events	2 year	2 years progress free survival and overall suvival as measured by RECIST criteria 4.0

Secondary Outcome Measures

Name	Time	Method
Antigen specific cell responses before and after vaccination	2 year	Immunological response based on measuring increased numbers of IDH1R132H specific T cells and levels of anti-IDH1R132H antibody.

Trial Locations

Locations (2)

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China

Hebei Yanda Hospital; 🇨🇳 Sanhe, Hebei, China