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

2 июля 2021 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

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).

Тип исследования

Интервенционный

Регистрация (Действительный)

24

Фаза

  • Фаза 2
  • Фаза 1

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

19 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Да

Полы, имеющие право на обучение

Все

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Нерандомизированный
  • Интервенционная модель: Одногрупповое задание
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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).
Биологический: 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).
Другие имена:
  • Intramuscular injections of autologous total IgG
Экспериментальный: 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).
Биологический: 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).
Другие имена:
  • Intramuscular injections of autologous total IgG

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Временное ограничение
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
Временное ограничение: 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
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Number of participants with abnormal serum chemistry results and blood test results due to clinical study in healthy subjects
Временное ограничение: From baseline to week 12
From baseline to week 12
Serum concentrations of immunological parameters (immunoglobulin, cytokine, etc.) in healthy subjects
Временное ограничение: From baseline to week 12
From baseline to week 12
Lymphocyte fraction by flow cytometry analysis of peripheral blood mononuclear cells in healthy subjects
Временное ограничение: From baseline to week 12
From baseline to week 12
Levels of cytokines secreted from peripheral blood cells in healthy subjects
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Ajou University School of Medicine

Следователи

  • Главный следователь: Dong-Ho Nahm, Ajou University School of Medicine

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

6 ноября 2018 г.

Первичное завершение (Действительный)

26 января 2021 г.

Завершение исследования (Действительный)

24 марта 2021 г.

Даты регистрации исследования

Первый отправленный

28 сентября 2018 г.

Впервые представлено, что соответствует критериям контроля качества

2 октября 2018 г.

Первый опубликованный (Действительный)

4 октября 2018 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

6 июля 2021 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

2 июля 2021 г.

Последняя проверка

1 июля 2021 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Другие идентификационные номера исследования

  • AJIRB-MED-THE-18-236

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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