Development of a New Immunotherapy Using Intramuscular Administration of Autologous Total IgG
2021년 7월 2일 업데이트: Dong-Ho Nahm, Ajou University School of Medicine
Evaluation of Immunostimulatory Effect of Intramuscular Administration of Autologous Total IgG in Human for Development of a New Immunotherapy
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.
연구 개요
상세 설명
After providing informed consent, study participants will be assessed for study eligibility at the screening visit. At screening visit (week -4), venous blood (320~400 mL) will be sampled using a double blood bag containing anticoagulant. Autologous plasma will be separated from the venous blood by centrifugation. During the 4 weeks of screening period, autologous total IgG (purity ≥97%) will be aseptically purified from the autologous plasma by chromatography using Protein A. Participants will receive the 8 intramuscular injections of autologous total IgG, twice a week for 4 weeks from baseline (week 0).
The investigators will evaluate the safety and immunostimulatory effect of intervention of this study by analyzing side effects, serum concentrations of immunological parameters (immunoglobulin, cytokine, etc.), and lymphocyte fraction by flow cytometry analysis of peripheral blood mononuclear cells.
[Part A) Autologous total IgG therapy in healthy subjects] The duration of this clinical study in healthy subjects is 16 weeks from the screening visit. A 4-week screening period will be followed by a 4-week intervention period and an 8-week follow-up period.
[Part B) Autologous total IgG therapy in patients with advanced solid tumor] The duration of this clinical study in patients with advanced solid tumor is 12 weeks from the screening visit. A 4-week screening period will be followed by a 4-week intervention period and a 4-week follow-up period(1 cycle).
If the patients agree to participate in additional long-term repeated study interventions at the end of 1st cycle of visit, patients will receive repeated study interventions in same the schedule up to week 44 (maximum 4 cycles). At the end of each cycle, antitumor effect will be evaluated by serum tumor marker concentrations, anatomical imaging, and Response Evaluation Criteria in solid tumors (RECIST ver. 1.1).
연구 유형
중재적
등록 (실제)
24
단계
- 2 단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Gyeong-gi Do
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Suwon, Gyeong-gi Do, 대한민국, 16499
- Ajou university hosiptal
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
19년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- 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.)
Exclusion Criteria:
- 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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Part A) Healthy subjects
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).
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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).
다른 이름들:
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실험적: Part B) Advanced solid tumor
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).
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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).
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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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
기간: From baseline to week 12
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From baseline to week 12
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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
기간: From baseline to week 8 and through study completion, an average of 3 year
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From baseline to week 8 and through study completion, an average of 3 year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of participants with abnormal serum chemistry results and blood test results due to clinical study in healthy subjects
기간: From baseline to week 12
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From baseline to week 12
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Serum concentrations of immunological parameters (immunoglobulin, cytokine, etc.) in healthy subjects
기간: From baseline to week 12
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From baseline to week 12
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Lymphocyte fraction by flow cytometry analysis of peripheral blood mononuclear cells in healthy subjects
기간: From baseline to week 12
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From baseline to week 12
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Levels of cytokines secreted from peripheral blood cells in healthy subjects
기간: From baseline to week 12
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From baseline to week 12
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Quality of life (5-level EuroQoL Group's 5-dimension; EQ-5D-5L) in healthy subjects
기간: From baseline to week 12
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The 5-level EuroQoL Group's 5-dimension (EQ-5D-5L) consists of 2 parts: the descriptive system and the EQ visual analogue scale (VAS).
The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Each dimension has 5 levels of perceived problems: no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems.
In addition, the EQ-5D-5L include an EQ-VAS where the endpoints are labeled on a scale from 0 (worst imaginable health) to 100 (best imaginable health).
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From baseline to week 12
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Subjective index of pain and fatigue (Visual Analogue Scale; VAS, Numeral Rating Scale; NRS) in healthy subjects
기간: From baseline to week 12
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The 100-mm Visual Analogue Scale (VAS) ranges from 0 (absent) to 10 (worst imaginable).
The 11-point Numerical Rating Scale (NRS) ranges from 0 (absent) to 10 (worst imaginable).
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From baseline to week 12
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Number of participants with abnormal serum chemistry results and blood test results due to clinical study in patients with advanced solid tumor
기간: From baseline to week 8 and through study completion, an average of 3 year
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From baseline to week 8 and through study completion, an average of 3 year
|
|
|
Serum concentrations of immunological parameters (immunoglobulin, cytokine, etc.) in patients with advanced solid tumor
기간: From baseline to week 8 and through study completion, an average of 3 year
|
From baseline to week 8 and through study completion, an average of 3 year
|
|
|
Lymphocyte fraction by flow cytometry analysis of peripheral blood mononuclear cells in patients with advanced solid tumor
기간: From baseline to week 8 and through study completion, an average of 3 year
|
From baseline to week 8 and through study completion, an average of 3 year
|
|
|
Levels of cytokines secreted from peripheral blood cells in patients with advanced solid tumor
기간: From baseline to week 8 and through study completion, an average of 3 year
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From baseline to week 8 and through study completion, an average of 3 year
|
|
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Objective response rate (ORR) in patients with advanced solid tumor
기간: From baseline to week 8 and through study completion, an average of 3 year
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From baseline to week 8 and through study completion, an average of 3 year
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Disease control rate (DCR) in patients with advanced solid tumor
기간: From baseline to week 8 and through study completion, an average of 3 year
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From baseline to week 8 and through study completion, an average of 3 year
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|
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Duration of response (DOR) in patients with advanced solid tumor
기간: From baseline to week 8 and through study completion, an average of 3 year
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From baseline to week 8 and through study completion, an average of 3 year
|
|
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Progression-free survival (PFS) in patients with advanced solid tumor
기간: From baseline to week 8 and through study completion, an average of 3 year
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From baseline to week 8 and through study completion, an average of 3 year
|
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Overall survival (OS) in patients with advanced solid tumor
기간: From baseline to week 8 and through study completion, an average of 3 year
|
From baseline to week 8 and through study completion, an average of 3 year
|
|
|
The tumor marker concentrations in patients with advanced solid tumor
기간: From baseline to week 8 and through study completion, an average of 3 year
|
From baseline to week 8 and through study completion, an average of 3 year
|
|
|
Quality of life (5-level EuroQoL Group's 5-dimension; EQ-5D-5L) in patients with advanced solid tumor
기간: From baseline to week 8 and through study completion, an average of 3 year
|
The 5-level EuroQoL Group's 5-dimension (EQ-5D-5L) consists of 2 parts: the descriptive system and the EQ visual analogue scale (VAS).
The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Each dimension has 5 levels of perceived problems: no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems.
In addition, the EQ-5D-5L include an EQ-VAS where the endpoints are labeled on a scale from 0 (worst imaginable health) to 100 (best imaginable health).
|
From baseline to week 8 and through study completion, an average of 3 year
|
|
Subjective index of pain and fatigue (Visual Analogue Scale; VAS, Numeral Rating Scale; NRS) in patients with advanced solid tumor
기간: From baseline to week 8 and through study completion, an average of 3 year
|
The 100-mm Visual Analogue Scale (VAS) ranges from 0 (absent) to 10 (worst imaginable).
The 11-point Numerical Rating Scale (NRS) ranges from 0 (absent) to 10 (worst imaginable).
|
From baseline to week 8 and through study completion, an average of 3 year
|
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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Dong-Ho Nahm, Ajou University School of Medicine
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2018년 11월 6일
기본 완료 (실제)
2021년 1월 26일
연구 완료 (실제)
2021년 3월 24일
연구 등록 날짜
최초 제출
2018년 9월 28일
QC 기준을 충족하는 최초 제출
2018년 10월 2일
처음 게시됨 (실제)
2018년 10월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 7월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 7월 2일
마지막으로 확인됨
2021년 7월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- AJIRB-MED-THE-18-236
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