NCT02602249Unknown1 期
Phase 1 Study of Antigen-specific Cytotoxic T Lymphocytes Induced by Dendritic Cells Infected by Recombinant Adeno-associated Virus With MUC1 Gene(MUC1-gene-DC-CTL) or Directly Pulsed by MUC1 Peptide(MUC1-peptide-DC-CTL) in Gastric Cancer.
Beijing Doing Biomedical Co., Ltd.4 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2017年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Reduced size of the tumor.
研究概览
简要总结
In this study, safety and effects of MUC1-gene-DC-CTL and MUC1-peptide-DC-CTL on human gastric cancer are going to be investigated.
详细描述
PBMC of the patient will be separated from peripheral blood.DCs infected by MUC1 and pulsed by MUC-1 peptide are made respectively from PBMC, then they are respectively cultured with T cells into MUC1-gene-DC-CTL and MUC1-peptide-DC-CTL which will be infused to the patients as immunotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sex: male or female
- •Age: from 18 to 80 years
- •Histology: gastric cancer
- •Clinical stage: stage IV
- •Karnofsky performance status: more than 50%
- •Expected survival: more than 2 months
- •Laboratory tests results 7 days before the start of treatment:
- •White blood cells: more than 3.0 × 109/L
- •Platelets: more than 100 × 109/L
- •Neutrophils: more than 1.5 × 109/L
- •Hemoglobin: more than 80g/L
- •Serum glutamate pyruvate transaminase: less than 2.5 folds of the upper normal limit (ULN)
- •Serum glutamic-oxal (o) acetic transaminase: less than 2.5 × ULN
- •Serum bilirubin: less than 1.25 × ULN
- •Serum creatinine: less than 1.25 × ULN
- •Pregnancy test: the test of women of child-bearing period must be negative 7 days before the start of treatment
- •Contraception: male and female subjects of child-bearing period must adopt a reliable method of contraception before entry into this study until 30 days after stopping this study
- •Informed consent: subject must have the ability to understand and voluntarily sign a written informed consent
排除标准
- •History of neoplasms: other neoplasms
- •Medical history: mental disease, or congestive heart failure, or severe coronary artery disease, or cardiac arrhythmias, or concomitant corticosteroid therapy
- •Metastasis: clinical symptoms of brain metastasis
- •Other clinical trial: the subject received other clinical trial before this study
- •Laboratory tests: the serum test of human immunodeficiency virus, or hepatitis B virus, or hepatitis C virus was positive
- •Woman: pregnant or lactating women
- •Compliance: poor compliance
研究组 & 干预措施
Experimental Group A(control group)
No Intervention
saline infusion and follow up
Experimental Group B
Experimental
MUC1-gene-DC-CTL will be used against tumor cells.
干预措施: MUC1-gene-DC-CTL (Biological)
Experimental Group C
Experimental
MUC1-peptide-DC-CTL will be used against tumor cells.
干预措施: MUC1-peptide-DC-CTL (Biological)
结局指标
主要结局
Reduced size of the tumor.
时间窗: up to one year
Tumor load will be evaluated by RECIST criteria.
次要结局
- Safety, as measured by the rate of adverse events and serious adverse events(up to two years)
研究者
研究点 (4)
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