Collection of Peripheral Blood Mononuclear Cells From Healthy Subjects for the Development of Cellular Immunotherapy Product
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Collect blood samples
研究概览
简要总结
Title: Collection of Peripheral Blood Mononuclear Cells (PBMCs) From Healthy Subjects for the Development of Cellular Immunotherapy Product
Background:
CAR-T therapies are being developed that utilize modified immune cells to fight tumors. 'Off-the-shelf' allogeneic CAR-T technology has better efficacy and more promising clinical applications. Investigators want to use the cells of healthy subjects to perform the studies. To accomplish this, they are collecting PBMCs through apheresis.
Objectives:
To collect PBMCs from healthy subjects for product development for cell Immunotherapies.
详细描述
Background:
Autologous chimeric antigen receptor (CAR) T cells have changed the therapeutic landscape in haematological malignancies. Nevertheless, the use of allogeneic CAR T cells from donors has many potential advantages over autologous approaches, such as the immediate availability of cryopreserved batches for patient treatment, possible standardization of the CAR-T cell product, time for multiple cell modifications, redosing or combination of CAR T cells directed against different targets, and decreased cost using an industrialized process. The T cells currently used for CAR-T cell manufacturing are mainly derived from peripheral blood mono-nuclear cells (PBMCs) .The manufacture of allogeneic CAR T cells from PBMCs collected from healthy donors is associated with the ability to make multiple vials from a single apheresis product. Allogeneic CAR T cells are created from healthy donors, they are generated from immune cells that have not been impacted by the immune effects of cancer or by exposure to chemotherapeutic agents, in contrast to autologous T cells from patients. The selection of donors on the basis of their immune characteristics is likely to be a key factor in decreasing the heterogeneity of the final cell product
Objectives:
- To produce allogeneic CAR T cells with different targets and other cell products by using PBMCs from healthy subjects.
- To develop and optimize the methodology for the response or quality determination of cell Immunotherapy products.
Design:
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
- •18 to 40 years of age
- •Male≥50 kg, female≥45 kg with 18.5≤ BMI ≤30
- •Subject has provided informed consent
排除标准
- •Subject has respiratory diseases, circulatory system diseases, digestive system diseases, urinary system diseases, hematological system diseases, autoimmune diseases, endocrine disorders or metabolic disorders;
- •Subject has nervous system diseases, mental illness, Creutzfeldt-Jakob disease or those with a family history, or those treated with tissue or tissue derivatives that may be derived from Creutzfeldt-Jakob infected people;
- •Subject has chronic skin diseases, especially infectious, allergic or inflammatory systemic skin diseases;
- •Subject has allergic diseases or recurrent allergies;
- •Malignant tumors or health-affecting benign tumors;
- •Twice or more times of blood pressure measurement exhibit (except for white coat hypertension): systolic blood pressure < 90 or ≥ 140 Millimeter of mercury (mm Hg), or diastolic blood pressure < 60 or ≥ 90 mm Hg, or pulse pressure < 30 mm Hg, heart rate: < 60 beats/min or >100 beats/min;
- •Laboratory tests: hemoglobin: male <120 g/L, female <115 g/L, or liver and kidney laboratory result >1.5x upper limit of normal with clinical significant, or abnormal12-lead ECG with clinical significant, or abnormal abdominal B-mode ultrasound with clinical significant, or abnormal chest X-ray with clinical significant, and T cell detection of tuberculosis infection is over the limit or positive;
- •Abnormal lymphocyte subset panel test result with clinical significance (Lymphs%, CD3+, CD3+CD4+, CD3+CD8+, CD3-CD16+CD56+,CD19+) ;
- •Hepatitis B surface antigen positive, hepatitis B virus (HBV) DNA positive, hepatitis B e antigen positive, hepatitis C antibody positive, Treponema pallidum antibody positive ,human immunodeficiency virus antibody positive, human T-cell lymphotrophic virus antibody positive, Epstein-Barr virus positive, or COVID-19 nucleic acid positive ;
- •Recipient of organ transplant;
- •Received any major organ resection such as stomach, kidney, spleen and lung;
- •Subject has transfusion-associated infectious diseases;
- •Minor surgery within 3 months, such as appendectomy and recovered ophthalmic surgery; Major surgery within l 1 year, such as surgical treatment for gynecological benign tumors or superficial benign tumors;
- •Pregnant, or have an abortion within l 6 months, childbirth within 1 year;
- •Upper respiratory infection recovered within 1 week, or pneumonia recovered within 3 months;
- •Acute pyelonephritis-recovered within 3 months, or urinary calculi onset;
- •Injured or wound-contaminated by equipment contaminated by blood or tissue fluids, or has a tattoo within 1 year;
- •Received whole blood and blood component transfusion within 1 year;
- •Received the last vaccination of live attenuated vaccines such as measles, mumps, or polio within 2 weeks, or the last vaccination of rubella live vaccine, human rabies vaccine, live attenuated Japanese encephalitis vaccine within 4 weeks;
- •Received the last vaccination of rabies vaccines after being bitten by an animal within 1 year;
- •Received the last vaccination of antitoxin or immune serum injection within 4 weeks, or those who received the last vaccination of hepatitis B human immunoglobulin injection within 1 year;
- •Participated in a clinical trials within 1 month; it should be discussed case by base if investigational product used.
- •Those who are considered by the investigator as unsuitable for participating in the study.
结局指标
主要结局
Collect blood samples
时间窗: 2 years
Collect blood samples (whole blood and PBMC) from healthy subjects for the Development of Cellular Immunotherapy Product.
次要结局
未报告次要终点
研究者
Jun Zhu
Chief Physician
Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai