Safety and Efficacy of IDH1R132H-DC Vaccine in Gliomas

Hebei Yanda Hospital

Status: Unknown

Conditions: Glioma

Treatments: Biological: dendritic cells

Study type: Interventional

Funder types: Other

Identifiers

NCT02771301

IDH1

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

dendritic cell

Other group

Description:

Patients will receive autolgous IDH1R132H dendritic cells and cytotoxic lymphocytes treatment.

Treatment:

Biological: dendritic cells