KCT0004064招募中未知
A Phase I study of autologous hTERT-specific CD8+ T cell immunotherapy in patients with advanced solid tumors who failed standard therapy
CC Hospital0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •1) Subjects must be 20 ~ 75 years old
- •2) Patients with standard therapy-failed reccurrent sold cancers
- •3) Patients with hTERT-specific CD8 T cells in prior epitope screening.
- •4) Performance Status Score (ECOG/Zubrod Scale) must be =< 2
排除标准
- •1) Patients who have Symptoms- or unregulated with metastasis in CNS
- •2) Patients recieved all immunosuppressive treatments such as chemotherapy or radiotherapy a minimum of 3 weeks prior to initiation of study
- •3) Leukocyte number < 2,500/ul, absolute numbers of neutrophils < 1,000/ul, platelet numbers < 50,000/ul, hemoglobin <9g/dL, serum creatinine > 2.0mg/dL, AST/ALT > 3x upper limit of normal range (ULN), total bilirubin > 2.0 mg/dL, Prothrombin time > 1.5 x ULN
- •4) Active cardiovascular diseases, including:
- •unregulated hypertension( Systolic blood pressure>180mmHg, Diastolic blood pressure>100mmHg), Unstable angina, Pulmonary embolisim, cerebrovascular disease, valvular disease of the heart , congestive heart failure or myocardial infarction in the last 6 months, or severe arrhythmia
- •5) Anti-HIV Ab positive
- •6) Patients with active autoimmune diseases or inflammatory diseases
- •7) Uncontrolled active infection/neurologic diseases
- •8) Patients with a previous history of immune cell therapy
- •9) Pregnant or breast-feeding women
研究者
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