Evaluation of immunostimulatory effect of intramuscular administration of autologous total IgG in human for development of a new immunotherapy

Ajou University Hospital0 个研究点目标入组 30 人开始时间: 待定最近更新: 2020年6月15日

适应症

试验速览

暂无简介。

•1. Male or female, 19 years or older
•2. Meeting the criteria for autologous blood donation
•1) Body weight =32 kg (satisfying body weight limitation for planned sampling of 320 mL of venous blood volume)
•2) Hemoglobin: = 9 g/dL (Healthy volunteers Hemoglobin: = 11 g/dL)
•3. Provide signed informed consent
•4. [Only for patients with advanced solid tumor] Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) = 2 at the time of study enrollment.
•5. [Only for patients with advanced solid tumor] Patients with a life expectancy longer than 3 months and metastatic (stage ?, ?) advanced solid tumor (non-small cell lung cancer, stomach cancer, colon cancer, ovarian cancer, breast cancer, pancreatic cancer, cholangiocarcinoma, malignant melanoma, renal cell carcinoma, etc.)
•6. [Only for patients with advanced solid tumor] One or more target lesions must be present as confirmed by anatomical imaging (X-ray, CT sacn, MRI, etc.)

•1. Subjects under the age of 19 year, or unable to agree on their own (emergency patients, patients with mental disability, patients with limited capacity to consent due to stroke or delirium caused by diabetes), or severe disease whose expected survival duration is less than 3 months
•2. Pregnancy or planned pregnancy within 1 year
•3. Subjects who participated on another investigational device or drug studies within 4 weeks prior to screening visit
•4. Medical history of alcohol or drug abuse within 2 years of the screening visit
•5. Subjects is a member of the investigational team
•6. Unable to comply with all clinic visits and study-related procedures
•7. Planned or anticipated major surgical procedure within 4 weeks prior to baseline visit
•8. [Only for patients with advanced solid tumor] A well-treated patients in combination with surgery and radiotherapy
•9. [Only for patients with advanced solid tumor] Uncontrolled infections (bacterial, viral, fungal infection)
•10. [Only for patients with advanced solid tumor] Has known active brain metastases(except for subjects with adequate treated and neurological asymptomatic at least 2 weeks, subjects without neurological symptoms without treatment for brain metastases, also subjects must be either off corticosteroid for corticosteroid therapy, or who have received stable doses of prednisone less than 10mg daily or who have received reduced doses may be enrolled.

发起方

Ajou University Hospital