Development of a New Immunotherapy Using Intramuscular Administration of Autologous Total IgG

NCT03695757 | Completed Phase 1

• 1 other identifier: AJIRB-MED-THE-18-236
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Immunotherapy

Keywords

Immunoglobulin G; Treatment; Immunostimulatory effect; Tumor; Solid tumor

Outcome Measures

Primary Outcomes (2)

• 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

  From baseline to week 12

• 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

  From baseline to week 8 and through study completion, an average of 3 year

Secondary Outcomes (18)

• Number of participants with abnormal serum chemistry results and blood test results due to clinical study in healthy subjects

  From baseline to week 12

• Serum concentrations of immunological parameters (immunoglobulin, cytokine, etc.) in healthy subjects

  From baseline to week 12

• Lymphocyte fraction by flow cytometry analysis of peripheral blood mononuclear cells in healthy subjects

  From baseline to week 12

• Levels of cytokines secreted from peripheral blood cells in healthy subjects

  From baseline to week 12

• Quality of life (5-level EuroQoL Group's 5-dimension; EQ-5D-5L) in healthy subjects

  From baseline to week 12

Study Arms (2)

Part A) Healthy subjects

EXPERIMENTAL

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).

Biological: Part A) Healthy subjects

Part B) Advanced solid tumor

EXPERIMENTAL

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).

Biological: Part B) Advanced solid tumor

Interventions

Part A) Healthy subjects BIOLOGICAL

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).

Also known as: Intramuscular injections of autologous total IgG

Part A) Healthy subjects

Part B) Advanced solid tumor BIOLOGICAL

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).

Also known as: Intramuscular injections of autologous total IgG

Part B) Advanced solid tumor

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 19 years or older
• 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)
• Provide signed informed consent
• \[Only for patients with advanced solid tumor\] Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2 at the time of study enrollment.
• \[Only for patients with advanced solid tumor\] 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.)
• \[Only for patients with advanced solid tumor\] One or more target lesions must be present as confirmed by anatomical imaging (X-ray, CT sacn, MRI, etc.)

You may not qualify if:

• 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
• Pregnancy or planned pregnancy within 1 year
• Subjects who participated on another investigational device or drug studies within 4 weeks prior to screening visit
• Medical history of alcohol or drug abuse within 2 years of the screening visit
• Subjects is a member of the investigational team
• Unable to comply with all clinic visits and study-related procedures
• Planned or anticipated major surgical procedure within 4 weeks prior to baseline visit
• \[Only for patients with advanced solid tumor\] A well-treated patients in combination with surgery and radiotherapy
• \[Only for patients with advanced solid tumor\] Uncontrolled infections (bacterial, viral, fungal infection)
• \[Only for patients with advanced solid tumor\] 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.

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Ajou university hosiptal

Suwon, Gyeong-gi Do, 16499, South Korea

Location

Related Publications (1)

• Kwon 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 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Dong-Ho Nahm

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Intramuscularly administrations of autologous total IgG in healthy subjects and patients with advanced solid tumor

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 4, 2018
• Study Start: November 6, 2018
• Primary Completion: January 26, 2021
• Study Completion: March 24, 2021
• Last Updated: July 6, 2021

Record last verified: 2021-07

Locations

KR (1)