Clinical trial · Interventional
Development of a New Immunotherapy Using Intramuscular Administration of Autologous Total IgG
Evaluation of Immunostimulatory Effect of Intramuscular Administration of Autologous Total IgG in Human for Development of a New Immunotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this prospective pilot clinical study is to evaluate the safety and immunostimulatory effect of intramuscularly administrations of autologous total IgG (autologous total IgG therapy) in healthy subjects and patients with advanced solid tumor (non-small cell lung cancer, stomach cancer, colon cancer, ovarian cancer, breast cancer, pancreatic cancer, biliary cancer, melanoma, renal cell carcinoma etc.). In addition, antitumor effect of intramuscularly administrations of autologous total IgG in patients with advanced solid tumor will be also evaluated.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Immunotherapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Part A) Healthy subjects | Biological | — | UNRESOLVED |
| Part B) Advanced solid tumor | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part A) Healthy subjects
- description
- Part A) Autologous total IgG 50mg will be administered to the healthy subjects by intramuscular injections, twice a week for 4 weeks (total 8 injections).
- interventionNames
- Biological: Part A) Healthy subjects
- type
- EXPERIMENTAL
- label
- Part B) Advanced solid tumor
- description
- Part B) Autologous total IgG 50mg will be administered to the patients with advanced solid tumor by intramuscular injection, twice a week for 4 weeks (total 8 injections).
- interventionNames
- Biological: Part B) Advanced solid tumor
Primary outcomes (2)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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 Ⅲ, Ⅳ) 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: 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.
References
Publications (1)
- DERIVEDKwon B, Yang SJ, Cho SM, Kim ME, Nahm DH. Intramuscular administration of autologous total immunoglobulin G induces immunomodulatory effects on T cells in healthy human subjects: An open-labeled prospective single-arm trial. Medicine (Baltimore). 2022 Jun 3;101(22):e29486. doi: 10.1097/MD.0000000000029486. PMID 35665739