JPRN-jRCTc030190183已完成2 期
Safety assessment of neoantigen peptides-loaded dendritic cell vaccination therapy. - Vaccination with neoantigen-loaded DCs
Tanigawa Keishi0 个研究点目标入组 20 人开始时间: 2020年1月14日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
eoantigen DCs would be a safe treatment method. Neoantigen DCs would induce the acquisition of immune reaction against neoantigens.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 12age old 至 <= 85age old（—）
- 性别
- All
入选标准
- •A patient must:
- •- have ECOG Performance Status of 0, 1 and 2.
- •- maintain adequate function of key organs when the eligibility is confirmed, in particular:
- •1. haemoglobin 8.0 g/dl or more
- •2. platelet 50.000 /mm3 or more
- •3. total bilirubin 3 x ULN or more
- •4. AST/ALT 3 x ULN or less
- •5. creatinine 3 x ULN or less
- •- provide written consent for genetic analysis of tumor sample; neoantigen-screening analysis, and for treatment of those neoantigens-loaded DC vaccination.
- •- have a proper mental condition and an ability to recognize the object and contents of the study when informed consent is obtained.
排除标准
- •A patient must not:
- •- be impossible to obtain blood sample by Leukapeheresis.
- •- be positive in HIV antibody test.
- •- have active auto-immune disorder.
- •- have serious underlying disease.
- •- be pregnant (including pregnancy seeker)
- •- be judged ineligibles by clinician in this trial.
研究者
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