NCT01694472Unknown1 期
Phase 1 Study of MAGE-A4 TCR Gene-Modified T Cells to Treat Malignant Tumors
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
The purpose of this study is to evaluate the clinical safety and preliminary efficacy of MAGE-A4 TCR Gene-Modified T lymphocytes in the treatment of malignant solid tumor patients, such as malignant melanoma and lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Patients must have histologically confirmed solid tumors that have failed standard therapies (surgery, chemotherapy, radiotherapy) and for which no curative options exist, including, but not limited to:
- •Non-Small Cell Lung Carcinoma Malignant melanoma Esophageal carcinoma Head and neck carcinoma
- •HLA-A*24:02
- •MAGE-A4 positive in the test by RT-PCR on tumor tissue or immunohistochemistry of resected tissue of the patient.
- •PS ECOG 0 or <2
- •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
- •Patients with life-threatening condition or complication other than their basic disease
- •Pregnant or lactation. Patients both males and female with reproductive potential (i.e. menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration
- •Active systemic infections
- •History of neoplasms: other neoplasms
- •Medical history: active CNS 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
- •Compliance: poor compliance
结局指标
主要结局
Objective response rate
时间窗: Up to 12 months
CR + PR = ORR
次要结局
未报告次要终点
研究者
研究点 (1)
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