Clinical trial · Interventional
Safety and Efficacy of IDH1R132H-DC Vaccine in Gliomas
NCT02771301CI-TRIAL-00022162unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial is aimed at evaluating the safety and efficacy of IDH1R132H-DC vaccine in glioma with IDH1R132H mutation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dendritic cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- dendritic cell
- description
- Patients will receive autolgous IDH1R132H dendritic cells and cytotoxic lymphocytes treatment.
- interventionNames
- Biological: dendritic cells
Primary outcomes (1)
- measure
- Safety and Efficacy of IDH1R132H dendritic cell vaccine as measured by adverse events
- timeFrame
- 2 year
- description
- 2 years progress free survival and overall suvival as measured by RECIST criteria 4.0
Secondary outcomes (1)
- measure
- Antigen specific cell responses before and after vaccination
- timeFrame
- 2 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.