Development of a New Immunotherapy Using Intramuscular Administration of Autologous Total IgG
2021年7月2日 更新者：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.
調査の概要
詳細な説明
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).
研究の種類
介入
入学 (実際)
24
段階
- フェーズ2
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Gyeong-gi Do
-
Suwon、Gyeong-gi Do、大韓民国、16499
- Ajou university hosiptal
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
19年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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).
|
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).
他の名前：
|
|
実験的：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).
|
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).
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
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
時間枠：From baseline to week 12
|
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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of participants with abnormal serum chemistry results and blood test results due to clinical study in healthy subjects
時間枠：From baseline to week 12
|
From baseline to week 12
|
|
|
Serum concentrations of immunological parameters (immunoglobulin, cytokine, etc.) in healthy subjects
時間枠：From baseline to week 12
|
From baseline to week 12
|
|
|
Lymphocyte fraction by flow cytometry analysis of peripheral blood mononuclear cells in healthy subjects
時間枠：From baseline to week 12
|
From baseline to week 12
|
|
|
Levels of cytokines secreted from peripheral blood cells in healthy subjects
時間枠：From baseline to week 12
|
From baseline to week 12
|
|
|
Quality of life (5-level EuroQoL Group's 5-dimension; EQ-5D-5L) in healthy subjects
時間枠：From baseline to week 12
|
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 12
|
|
Subjective index of pain and fatigue (Visual Analogue Scale; VAS, Numeral Rating Scale; NRS) in healthy subjects
時間枠：From baseline to week 12
|
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 12
|
|
Number of participants with abnormal serum chemistry results and blood test results due to clinical study in patients with advanced solid tumor
時間枠：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
|
|
|
Serum concentrations of immunological parameters (immunoglobulin, cytokine, etc.) in patients with advanced solid tumor
時間枠：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
時間枠：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
時間枠：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
|
|
|
Objective response rate (ORR) in patients with advanced solid tumor
時間枠：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
|
|
|
Disease control rate (DCR) in patients with advanced solid tumor
時間枠：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
|
|
|
Duration of response (DOR) in patients with advanced solid tumor
時間枠：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
|
|
|
Progression-free survival (PFS) in patients with advanced solid tumor
時間枠：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
|
|
|
Overall survival (OS) in patients with advanced solid tumor
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Dong-Ho Nahm、Ajou University School of Medicine
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年11月6日
一次修了 (実際)
2021年1月26日
研究の完了 (実際)
2021年3月24日
試験登録日
最初に提出
2018年9月28日
QC基準を満たした最初の提出物
2018年10月2日
最初の投稿 (実際)
2018年10月4日
学習記録の更新
投稿された最後の更新 (実際)
2021年7月6日
QC基準を満たした最後の更新が送信されました
2021年7月2日
最終確認日
2021年7月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- AJIRB-MED-THE-18-236
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。