NCT04448509Unknown不适用
Peripheral Blood Mononuclear Cell Collection Protocol for UCART Cell Tumor Immunotherapy Study
He Huang1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年6月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- the number of PBMC count
研究概览
简要总结
Peripheral blood mononuclear cell collection protocol for tumor immunotherapy study of UCAR-T cells
详细描述
Collect blood samples (whole blood and PBMC) from healthy donors for the development and production of UCAR-T cells
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female aged 18-40 years, no donation reaction in the past;
- •Weight: male ≥ 50 kg, female ≥ 45 kg, and 18.5 kg/m2 ≤ BMI ≤ 30 kg/m2;
- •Blood pressure:12.0 Kpa (90 mmHg) ≤ systolic pressure﹤18.7 Kpa (140 mmHg) 8.0 Kpa (60 mmHg) ≤ diastolic pressure﹤12.0 Kpa (90 mmHg) Pulse pressure ≥ 4.0Kpa (30mmHg);
- •Pulse: 60/min to 100/min. Athletes with high endurance ≥ 50/min, with regular rhythm;
- •Temperature: 36.3-37.2℃ (oral temperature);
- •Generally in good condition: no damage to important organs such as heart, lung, liver and kidney; no severe or uncontrolled infection; no history of severe mental disorders;
排除标准
- •Valetudinarian, with frequent dizziness, giddiness, tinnitus, hemophobia, fear of needles, faint, and Meniere's disease;
- •Sexually transmitted diseases (STDs), leprosy, AIDS, and HIV-1, HIV-2, CMV, EBV antibody positive;
- •History of liver diseases, HBsAg positive and HCV antibody positive. 1 year after the clinical cure of hepatitis A, normal ALT test results at 1 month interval for 3 consecutive times;
- •Relapsed allergic diseases, urticaria, bronchial asthma and drug allergies (Donors with simple urticaria who are not in acute attack are eligible to donate PBMC);
- •Pulmonary tuberculosis, renal tuberculosis, lymph node tuberculosis and bone tuberculosis;
- •Urinary system diseases (e.g. acute and chronic nephritis, chronic urinary system infection, nephrotic syndrome, acute and chronic renal insufficiency, etc.);
- •Various hematological diseases (including anemia, leukemia, polycythemia vera and various hemorrhagic and coagulative diseases);
- •Endocrine diseases or metabolic disorders (e.g. hyperthyroidism, acromegaly, diabetes insipidus, diabetes mellitus, etc.);
- •Organic nervous system diseases or psychoses (e.g. encephalitis, sequelae of brain trauma, epilepsy, schizophrenia, hysteria, severe neurasthenia, etc.);
- •Parasitic diseases and endemic diseases (e.g. kala-azar, schistosomiasis, filariasis, hookworm disease, taeniasis, paragonimiasis, Keshan disease, Kaschin-Beck disease, etc.);
- •Malignancies and benign tumors affecting health;
- •Undergone resection of stomach, kidney, gallbladder, spleen, lung and other important organs;
- •Exposure to harmful substances or radioactive substances (except for clinical radiology);
- •High-risk groups susceptible to HIV infection, such as drug users, homosexuals and people with multiple sexual partners;
- •Creutzfeldt-Jakob disease (CJD), variant Creutzfeldt disease (vCJD), family history, and treatment with human and animal pituitary-derived substances (e.g. growth hormone, gonadotropin, thyrotropin, etc.). Organ transplantation recipients (including cornea, bone marrow, dura mater) may be exposed to bovine spongiform encephalopathy (BSE) and vCJD;
- •Other diseases or conditions in which donors are ineligible to donate PBMC in the opinion of physicians;
结局指标
主要结局
the number of PBMC count
时间窗: 1 years
UCAR-T cell
次要结局
未报告次要终点
研究者
He Huang
Clinical Professor
Zhejiang University
研究点 (1)
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