None listed
Conditions
Interventions
Others : Autologous total IgG 50mg will be administered to the same subjects by intramuscular injections, twice a week for 4 weeks (total 8 injections).
Sponsors
Ajou University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.)
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with severe adverse events (AEs), serious adverse events (SAEs), treatment-related AEs, deaths, or discontinuation of study intervention due to AEs in patients with advanced solid tumor;Number of participants with severe adverse events (AEs), serious adverse events (SAEs), treatment-related AEs, deaths, or discontinuation of study intervention due to AEs in healthy subjects | — |
Secondary
| Measure | Time frame |
|---|---|
| Levels of cytokines secreted from peripheral blood cells in patients with advanced solid tumor;Objective response rate (ORR) in patients with advanced solid tumor;Overall survival (OS) in patients with advanced solid tumor;Number of participants with abnormal serum chemistry results and blood test results due to clinical study in healthy subjects;Serum concentrations of immunological parameters (immunoglobulin, cytokine, etc.) in healthy subjects;Lymphocyte fraction by flow cytometry analysis of peripheral blood mononuclear cells in healthy subjects;Subjective index of pain and fatigue (VAS, NRS) in patients with advanced solid tumor;Levels of cytokines secreted from peripheral blood cells in healthy subjects;Quality of life (EQ-5D-5L) in healthy subjects;Progression-free survival (PFS) in patients with advanced solid tumor;Subjective index of pain and fatigue (VAS, NRS) in healthy subjects;Number of participants with abnormal serum chemistry results and blood test results due to clinical study in patients with advanced solid tumor;Serum concentrations of immunological parameters (immunoglobulin, cytokine, etc.) in patients with advanced solid tumor;Lymphocyte fraction by flow cytometry analysis of peripheral blood mononuclear cells in patients with advanced solid tumor;Disease control rate (DCR) in patients with advanced solid tumor;Duration of response (DOR) in patients with advanced solid tumor;The tumor marker concentrations in patients with advanced solid tumor;Quality of life (EQ-5D-5L) in patients with advanced solid tumor | — |
Countries
Korea, Republic of
Contacts
Public ContactJi-Sun Kang
Ajou University Hospital
Outcome results
None listed