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

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合作者:

信息的提供 (责任方):

Dong-Ho Nahm，Ajou University School of Medicine

追踪信息

首次提交日期 ^ICMJE

September 28, 2018

首次发布日期e ^ICMJE

October 4, 2018

最后更新发布日期

October 4, 2018

预计研究开始日期 ^ICMJE

October 15, 2018

预计主要完成日期

May 31, 2021 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

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[ Time Frame: 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[ Time Frame: From baseline to week 8 and through study completion, an average of 3 year ]

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Number of participants with abnormal serum chemistry results and blood test results due to clinical study in healthy subjects[ Time Frame: From baseline to week 12 ]
Serum concentrations of immunological parameters (immunoglobulin, cytokine, etc.) in healthy subjects[ Time Frame: From baseline to week 12 ]
Lymphocyte fraction by flow cytometry analysis of peripheral blood mononuclear cells in healthy subjects[ Time Frame: From baseline to week 12 ]
Levels of cytokines secreted from peripheral blood cells in healthy subjects[ Time Frame: From baseline to week 12 ]
Quality of life (5-level EuroQoL Group's 5-dimension; EQ-5D-5L) in healthy subjects[ Time Frame: 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).
Subjective index of pain and fatigue (Visual Analogue Scale; VAS, Numeral Rating Scale; NRS) in healthy subjects[ Time Frame: 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).
Number of participants with abnormal serum chemistry results and blood test results due to clinical study in patients with advanced solid tumor[ Time Frame: 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[ Time Frame: 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[ Time Frame: 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[ Time Frame: From baseline to week 8 and through study completion, an average of 3 year ]
Objective response rate (ORR) in patients with advanced solid tumor[ Time Frame: From baseline to week 8 and through study completion, an average of 3 year ]
Disease control rate (DCR) in patients with advanced solid tumor[ Time Frame: From baseline to week 8 and through study completion, an average of 3 year ]
Duration of response (DOR) in patients with advanced solid tumor[ Time Frame: From baseline to week 8 and through study completion, an average of 3 year ]
Progression-free survival (PFS) in patients with advanced solid tumor[ Time Frame: From baseline to week 8 and through study completion, an average of 3 year ]
Overall survival (OS) in patients with advanced solid tumor[ Time Frame: From baseline to week 8 and through study completion, an average of 3 year ]
The tumor marker concentrations in patients with advanced solid tumor[ Time Frame: 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[ Time Frame: 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).
Subjective index of pain and fatigue (Visual Analogue Scale; VAS, Numeral Rating Scale; NRS) in patients with advanced solid tumor[ Time Frame: 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).

描述性信息

简略标题 ^ICMJE

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

正式标题 ^ICMJE

Evaluation of Immunostimulatory Effect of Intramuscular Administration of Autologous Total IgG in Human for Development of a New Immunotherapy

简要概况

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.

详细说明

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).

研究类型 ^ICMJE

Interventional

研究阶段

Phase 1/Phase 2

研究设计 ^ICMJE

分配: Non-Randomized
干预模型: Single Group Assignment
干预模型描述: Intramuscularly administrations of autologous total IgG in healthy subjects and patients with advanced solid tumor
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Biological: 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).
Biological: 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).

研究工具

Experimental: 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).
Experimental: 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).

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

May 31, 2021

预计主要完成日期

May 31, 2021 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

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: ≥ 11g/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 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] Uncontrolled infections (bacterial, viral, fungal infection) 9. [Only for patients with advanced solid tumor] Brain metastasis 10. [Only for patients with advanced solid tumor] In patients receiving chemotherapy, immunotherapy, radiotherapy, or treatment with hormone replacement therapy at the time of screening visit

性别

参与研究的性别:

All

年龄

最小年龄：19 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

Korea, Republic of

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

Dong-Ho Nahm，Ajou University School of Medicine

研究赞助商 ^ICMJE

Ajou University School of Medicine

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Dong-Ho Nahm Ajou University School of Medicine

PRS 账户

Ajou University School of Medicine

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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