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出境医 / 临床实验 / A Study on the Collection of Peripheral Blood Mononuclear Cells From Healthy Volunteers for the Development of Allogeneic Cellular Immunotherapy Products

A Study on the Collection of Peripheral Blood Mononuclear Cells From Healthy Volunteers for the Development of Allogeneic Cellular Immunotherapy Products

Study Description
Brief Summary:
The objective of the study is to collect peripheral blood mononuclear cells (PBMC) from healthy volunteers for the research and development of allogeneic cellular immunotherapy products.

Condition or disease Intervention/treatment Phase
Collection of Peripheral Blood Mononuclear Cells by Means of Apheresis Procedure: collection of peripheral blood mononuclear cells from healthy volunteers Not Applicable

Detailed Description:

The study is a single-center study.

  1. Screening period: All volunteers are required to sign a written informed consent form for the study; after the signing of informed consent form, the demographic data and medical history of the volunteers will be collected, and physical examinations and local laboratory tests will be performed to assess the eligibility of the volunteers. Volunteers who meet all the inclusion criteria and do not meet any exclusion criteria (except for the basic biological indicators of UCAR-T product preparation) will receive peripheral venous whole blood sampling, and the volunteers receiving apheresis based on the assessment results will be enrolled.
  2. Apheresis period: 5 volunteers who meet the inclusion criteria will undergo collection of peripheral blood mononuclear cells (PBMC) by means of apheresis.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Study on the Collection of Peripheral Blood Mononuclear Cells From Healthy Volunteers for the Development of Allogeneic Cellular Immunotherapy Products
Actual Study Start Date : September 26, 2019
Estimated Primary Completion Date : July 20, 2021
Estimated Study Completion Date : December 20, 2021
Arms and Interventions
Arm Intervention/treatment
collection of PBMC from healthy donors
  1. Screening period: All volunteers are required to sign a written informed consent form for the study; after the signing of informed consent form, the demographic data and medical history of the volunteers will be collected, and physical examinations and local laboratory tests will be performed to assess the eligibility of the volunteers. Volunteers who meet all the inclusion criteria and do not meet any exclusion criteria (except for the basic biological indicators of UCAR-T product preparation) will receive peripheral venous whole blood sampling, and the volunteers receiving apheresis based on the assessment results will be enrolled.
  2. Apheresis period: 5 volunteers who meet the inclusion criteria will undergo collection of peripheral blood mononuclear cells (PBMC) by means of apheresis.
Procedure: collection of peripheral blood mononuclear cells from healthy volunteers
  1. Screening period: All volunteers are required to sign a written informed consent form for the study; after the signing of informed consent form, the demographic data and medical history of the volunteers will be collected, and physical examinations and local laboratory tests will be performed to assess the eligibility of the volunteers. Volunteers who meet all the inclusion criteria and do not meet any exclusion criteria (except for the basic biological indicators of UCAR-T product preparation) will receive peripheral venous whole blood sampling, and the volunteers receiving apheresis based on the assessment results will be enrolled.
  2. Apheresis period: 5 volunteers who meet the inclusion criteria will undergo collection of peripheral blood mononuclear cells (PBMC) by means of apheresis.

Outcome Measures
Primary Outcome Measures :
  1. the number of PBMC [ Time Frame: two year ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years and ≤ 40 years, male or female;
  2. Weight: male ≥ 50 kg, female ≥ 45 kg; 18.5 ≤ BMI ≤ 30;
  3. Healthy volunteers who signed informed consent form.

Exclusion Criteria:

  1. Those with known respiratory, circulatory, digestive, urinary, blood, immune, endocrine disorders or metabolic disorders;
  2. Those with known neurological diseases, mental illnesses, Creutzfeldt-Jakob disease and those with a family history, or those treated with tissue or tissue derivatives that may be derived from Creutzfeldt-Jakob infected people;
  3. Those with known chronic skin diseases, especially infectious, allergic or inflammatory systemic skin diseases;
  4. Those with known allergic diseases or recurrent allergies;
  5. Those with known malignant tumors or health-affecting benign tumors;
  6. Two or more physical examination results of blood pressure have shown (except for white coat hypertension): systolic blood pressure < 90 or ≥ 140mmHg, or diastolic blood pressure < 60 or ≥ 90 mmHg, or pulse pressure difference < 30 mmHg, heart rate: < 60 beats/min or >100 beats/min;
  7. Laboratory tests: hemoglobin determination: male <120 g/L, female <115 g/L, or liver and kidney function is more than 1.5 times the upper limit of normal and clinically significant, or 12-lead ECG is abnormal and clinically significant, or abdominal B-mode ultrasound is abnormal and clinically significant, or chest X-ray is abnormal and clinically significant, and T cell detection of tuberculosis infection is over the limit or positive;
  8. lymphocyte subsets (lymphocyte proportion、CD3+、CD3+CD4+、CD3+CD8+、CD3-CD16+CD56+、CD19+)Abnormal detection and clinical significance;
  9. Those with positive hepatitis B surface antigen or HBV DNA, or hepatitis B e antigen, or hepatitis C antibody, or Treponema pallidum antibody, or human immunodeficiency virus antibody;
  10. Recipients of allogeneic tissue and organ transplants;
  11. Those who have undergone resection of vital internal organs such as stomach, kidney, spleen and lung;
  12. Those who have suffered from blood transfusion-associated infectious diseases;
  13. Those who have undergone minor surgery within less than 3 months, such as appendectomy and ophthalmic surgery; those who have undergone major surgery within less than 1 year, such as surgical treatment for gynecological benign tumors or superficial benign tumors;
  14. Women who are pregnant, or have an abortion within less than 6 months or have undergone less than 1 year after childbirth and lactation;
  15. Those whose upper respiratory tract infection has recovered for less than 1 week, or pneumonia has recovered for less than 3 months;
  16. Those whose acute pyelonephritis has recovered for less than 3 months, or those with acute exacerbation of urinary calculi;
  17. Those who have been injured or wound-contaminated by equipment contaminated by blood or tissue fluids, or who have got a tattoo for less than 1 year;
  18. Those who have received whole blood and blood component transfusion within 1 year;
  19. Those who have received the last vaccination of live attenuated vaccines such as measles, mumps, or polio within 2 weeks, or have received the last vaccination of rubella live vaccine, human rabies vaccine, live attenuated Japanese encephalitis vaccine within 4 weeks;
  20. Those who have received the last vaccination of rabies vaccines after being bitten by an animal within 1 year;
  21. Those who have received the last vaccination of antitoxin or immune serum injection within 4 weeks, or those who have received the last vaccination of hepatitis B human immunoglobulin injection within 1 year;
  22. Those who have participated in clinical trials within 1 month; if they have used investigational drugs, they need to be discussed case by case;
  23. Those who cannot meet the basic biological indicators for UCAR-T product preparation, specifically including positive blood safety indicator sterility test result, or positive mycoplasma test result, or culture product endotoxin test ≥ 10 EU/mL; basic biological indicator cell viability is < 70%, or the number of effective T lymphocytes cannot meet the needs of in vitro assessment, or the in vitro proliferative production characteristics of each component cell, or the proportion of each component cannot meet the UCAR-T preparation conditions;
  24. Those who are considered by the investigator as unsuitable for participating in the study.
Contacts and Locations

Contacts
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Contact: Huayuan Zhu, PhD& MD +8668306034 huayuan.zhu@hotmail.com

Locations
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China, Jiangsu
Hematological Department, People's Hospital of Jiangsu Province Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Wei Xu, Ph.D.    +86-2568302182    xuwei10000@hotmail.com   
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Nanjing Legend Biotechnology Co.,Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Wei Xu, PhD& MD The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
Tracking Information
First Submitted Date  ICMJE July 19, 2019
First Posted Date  ICMJE July 22, 2019
Last Update Posted Date April 29, 2020
Actual Study Start Date  ICMJE September 26, 2019
Estimated Primary Completion Date July 20, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2019)
the number of PBMC [ Time Frame: two year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study on the Collection of Peripheral Blood Mononuclear Cells From Healthy Volunteers for the Development of Allogeneic Cellular Immunotherapy Products
Official Title  ICMJE A Study on the Collection of Peripheral Blood Mononuclear Cells From Healthy Volunteers for the Development of Allogeneic Cellular Immunotherapy Products
Brief Summary The objective of the study is to collect peripheral blood mononuclear cells (PBMC) from healthy volunteers for the research and development of allogeneic cellular immunotherapy products.
Detailed Description

The study is a single-center study.

  1. Screening period: All volunteers are required to sign a written informed consent form for the study; after the signing of informed consent form, the demographic data and medical history of the volunteers will be collected, and physical examinations and local laboratory tests will be performed to assess the eligibility of the volunteers. Volunteers who meet all the inclusion criteria and do not meet any exclusion criteria (except for the basic biological indicators of UCAR-T product preparation) will receive peripheral venous whole blood sampling, and the volunteers receiving apheresis based on the assessment results will be enrolled.
  2. Apheresis period: 5 volunteers who meet the inclusion criteria will undergo collection of peripheral blood mononuclear cells (PBMC) by means of apheresis.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Collection of Peripheral Blood Mononuclear Cells by Means of Apheresis
Intervention  ICMJE Procedure: collection of peripheral blood mononuclear cells from healthy volunteers
  1. Screening period: All volunteers are required to sign a written informed consent form for the study; after the signing of informed consent form, the demographic data and medical history of the volunteers will be collected, and physical examinations and local laboratory tests will be performed to assess the eligibility of the volunteers. Volunteers who meet all the inclusion criteria and do not meet any exclusion criteria (except for the basic biological indicators of UCAR-T product preparation) will receive peripheral venous whole blood sampling, and the volunteers receiving apheresis based on the assessment results will be enrolled.
  2. Apheresis period: 5 volunteers who meet the inclusion criteria will undergo collection of peripheral blood mononuclear cells (PBMC) by means of apheresis.
Study Arms  ICMJE collection of PBMC from healthy donors
  1. Screening period: All volunteers are required to sign a written informed consent form for the study; after the signing of informed consent form, the demographic data and medical history of the volunteers will be collected, and physical examinations and local laboratory tests will be performed to assess the eligibility of the volunteers. Volunteers who meet all the inclusion criteria and do not meet any exclusion criteria (except for the basic biological indicators of UCAR-T product preparation) will receive peripheral venous whole blood sampling, and the volunteers receiving apheresis based on the assessment results will be enrolled.
  2. Apheresis period: 5 volunteers who meet the inclusion criteria will undergo collection of peripheral blood mononuclear cells (PBMC) by means of apheresis.
Intervention: Procedure: collection of peripheral blood mononuclear cells from healthy volunteers
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 19, 2019)
5
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 20, 2021
Estimated Primary Completion Date July 20, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥ 18 years and ≤ 40 years, male or female;
  2. Weight: male ≥ 50 kg, female ≥ 45 kg; 18.5 ≤ BMI ≤ 30;
  3. Healthy volunteers who signed informed consent form.

Exclusion Criteria:

  1. Those with known respiratory, circulatory, digestive, urinary, blood, immune, endocrine disorders or metabolic disorders;
  2. Those with known neurological diseases, mental illnesses, Creutzfeldt-Jakob disease and those with a family history, or those treated with tissue or tissue derivatives that may be derived from Creutzfeldt-Jakob infected people;
  3. Those with known chronic skin diseases, especially infectious, allergic or inflammatory systemic skin diseases;
  4. Those with known allergic diseases or recurrent allergies;
  5. Those with known malignant tumors or health-affecting benign tumors;
  6. Two or more physical examination results of blood pressure have shown (except for white coat hypertension): systolic blood pressure < 90 or ≥ 140mmHg, or diastolic blood pressure < 60 or ≥ 90 mmHg, or pulse pressure difference < 30 mmHg, heart rate: < 60 beats/min or >100 beats/min;
  7. Laboratory tests: hemoglobin determination: male <120 g/L, female <115 g/L, or liver and kidney function is more than 1.5 times the upper limit of normal and clinically significant, or 12-lead ECG is abnormal and clinically significant, or abdominal B-mode ultrasound is abnormal and clinically significant, or chest X-ray is abnormal and clinically significant, and T cell detection of tuberculosis infection is over the limit or positive;
  8. lymphocyte subsets (lymphocyte proportion、CD3+、CD3+CD4+、CD3+CD8+、CD3-CD16+CD56+、CD19+)Abnormal detection and clinical significance;
  9. Those with positive hepatitis B surface antigen or HBV DNA, or hepatitis B e antigen, or hepatitis C antibody, or Treponema pallidum antibody, or human immunodeficiency virus antibody;
  10. Recipients of allogeneic tissue and organ transplants;
  11. Those who have undergone resection of vital internal organs such as stomach, kidney, spleen and lung;
  12. Those who have suffered from blood transfusion-associated infectious diseases;
  13. Those who have undergone minor surgery within less than 3 months, such as appendectomy and ophthalmic surgery; those who have undergone major surgery within less than 1 year, such as surgical treatment for gynecological benign tumors or superficial benign tumors;
  14. Women who are pregnant, or have an abortion within less than 6 months or have undergone less than 1 year after childbirth and lactation;
  15. Those whose upper respiratory tract infection has recovered for less than 1 week, or pneumonia has recovered for less than 3 months;
  16. Those whose acute pyelonephritis has recovered for less than 3 months, or those with acute exacerbation of urinary calculi;
  17. Those who have been injured or wound-contaminated by equipment contaminated by blood or tissue fluids, or who have got a tattoo for less than 1 year;
  18. Those who have received whole blood and blood component transfusion within 1 year;
  19. Those who have received the last vaccination of live attenuated vaccines such as measles, mumps, or polio within 2 weeks, or have received the last vaccination of rubella live vaccine, human rabies vaccine, live attenuated Japanese encephalitis vaccine within 4 weeks;
  20. Those who have received the last vaccination of rabies vaccines after being bitten by an animal within 1 year;
  21. Those who have received the last vaccination of antitoxin or immune serum injection within 4 weeks, or those who have received the last vaccination of hepatitis B human immunoglobulin injection within 1 year;
  22. Those who have participated in clinical trials within 1 month; if they have used investigational drugs, they need to be discussed case by case;
  23. Those who cannot meet the basic biological indicators for UCAR-T product preparation, specifically including positive blood safety indicator sterility test result, or positive mycoplasma test result, or culture product endotoxin test ≥ 10 EU/mL; basic biological indicator cell viability is < 70%, or the number of effective T lymphocytes cannot meet the needs of in vitro assessment, or the in vitro proliferative production characteristics of each component cell, or the proportion of each component cannot meet the UCAR-T preparation conditions;
  24. Those who are considered by the investigator as unsuitable for participating in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Huayuan Zhu, PhD& MD +8668306034 huayuan.zhu@hotmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04027855
Other Study ID Numbers  ICMJE BM2L201903
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party WEI XU, The First Affiliated Hospital with Nanjing Medical University
Study Sponsor  ICMJE The First Affiliated Hospital with Nanjing Medical University
Collaborators  ICMJE Nanjing Legend Biotechnology Co.,Ltd.
Investigators  ICMJE
Principal Investigator: Wei Xu, PhD& MD The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
PRS Account The First Affiliated Hospital with Nanjing Medical University
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP