Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

2. juli 2021 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

24

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Korea, Republikken
    • Gyeong-gi Do
      • Suwon, Gyeong-gi Do, Korea, Republikken, 16499
        • Ajou university hosiptal

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

19 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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).
Biologisk: 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).
Andre navne:
  • Intramuscular injections of autologous total IgG
Eksperimentel: 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).
Biologisk: 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).
Andre navne:
  • Intramuscular injections of autologous total IgG

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ajou University School of Medicine

Efterforskere

  • Ledende efterforsker: Dong-Ho Nahm, Ajou University School of Medicine

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

6. november 2018

Primær færdiggørelse (Faktiske)

26. januar 2021

Studieafslutning (Faktiske)

24. marts 2021

Datoer for studieregistrering

Først indsendt

28. september 2018

Først indsendt, der opfyldte QC-kriterier

2. oktober 2018

Først opslået (Faktiske)

4. oktober 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. juli 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juli 2021

Sidst verificeret

1. juli 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • AJIRB-MED-THE-18-236

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Part A) Healthy subjects

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Paraguay

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner