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

2 lipca 2021 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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).

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

24

Faza

  • Faza 2
  • Faza 1

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Republika Korei
    • Gyeong-gi Do
      • Suwon, Gyeong-gi Do, Republika Korei, 16499
        • Ajou university hosiptal

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

19 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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).
Biologiczny: 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).
Inne nazwy:
  • Intramuscular injections of autologous total IgG
Eksperymentalny: 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).
Biologiczny: 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).
Inne nazwy:
  • Intramuscular injections of autologous total IgG

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Ramy czasowe
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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Ajou University School of Medicine

Śledczy

  • Główny śledczy: Dong-Ho Nahm, Ajou University School of Medicine

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

6 listopada 2018

Zakończenie podstawowe (Rzeczywisty)

26 stycznia 2021

Ukończenie studiów (Rzeczywisty)

24 marca 2021

Daty rejestracji na studia

Pierwszy przesłany

28 września 2018

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 października 2018

Pierwszy wysłany (Rzeczywisty)

4 października 2018

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 lipca 2021

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 lipca 2021

Ostatnia weryfikacja

1 lipca 2021

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • AJIRB-MED-THE-18-236

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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