Collection of Peripheral Blood Mononuclear Cells by Means of ApheresisNCT04027855
A Study on the Collection of Peripheral Blood Mononuclear Cells From Healthy Volunteers for the Development of Allogeneic Cellular Immunotherapy Products
A study testing collection of peripheral blood mononuclear cells from healthy volunteers in people with Collection of Peripheral Blood Mononuclear Cells by Means of Apheresis, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Collection of Peripheral Blood Mononuclear Cells by Means of Apheresis
- What is being tested?
- collection of peripheral blood mononuclear cells from healthy volunteers
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteChina
- Study dates
- 26 Sep 2019to 9 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ≥ 18 years and ≤ 40 years, male or female;
- Weight: male ≥ 50 kg, female ≥ 45 kg; 18.5 ≤ BMI ≤ 30;
- Healthy volunteers who signed informed consent form.
Who cannot join
- Those with known respiratory, circulatory, digestive, urinary, blood, immune, endocrine disorders or metabolic disorders;
- 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;
- Those with known chronic skin diseases, especially infectious, allergic or inflammatory systemic skin diseases;
- Those with known allergic diseases or recurrent allergies;
- Those with known malignant tumors or health-affecting benign tumors;
- 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;
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- 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;
- lymphocyte subsets （lymphocyte proportion、CD3+、CD3+CD4+、CD3+CD8+、CD3-CD16+CD56+、CD19+）Abnormal detection and clinical significance;
- 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;
- Recipients of allogeneic tissue and organ transplants;
- Those who have undergone resection of vital internal organs such as stomach, kidney, spleen and lung;
- Those who have suffered from blood transfusion-associated infectious diseases;
- 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;
- Women who are pregnant, or have an abortion within less than 6 months or have undergone less than 1 year after childbirth and lactation;
- Those whose upper respiratory tract infection has recovered for less than 1 week, or pneumonia has recovered for less than 3 months;
- Those whose acute pyelonephritis has recovered for less than 3 months, or those with acute exacerbation of urinary calculi;
- 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;
- Those who have received whole blood and blood component transfusion within 1 year;
- 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;
- Those who have received the last vaccination of rabies vaccines after being bitten by an animal within 1 year;
- 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;
- Those who have participated in clinical trials within 1 month; if they have used investigational drugs, they need to be discussed case by case;
- 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;
- Those who are considered by the investigator as unsuitable for participating in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Hematological Department, People's Hospital of Jiangsu Province
Nanjing, Jiangsu, 210029
About this study
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.
Read the detailed description
The study is a single-center study.
- 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.
- Apheresis period: 5 volunteers who meet the inclusion criteria will undergo collection of peripheral blood mononuclear cells (PBMC) by means of apheresis.
- Being tested
- collection of peripheral blood mononuclear cells from healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of peripheral blood mononuclear cells from healthy volunteersProcedure or surgery
- 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.
- Apheresis period: 5 volunteers who meet the inclusion criteria will undergo collection of peripheral blood mononuclear cells (PBMC) by means of apheresis.
| Study group | Role | What they receive |
|---|---|---|
| collection of PBMC from healthy donors | Other | 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. Receives: Procedure: collection of peripheral blood mononuclear cells from healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of PBMC
Measured: two year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start26 Sep 2019
- Primary completion9 Dec 2021
- Study completion9 Dec 2021
Why it stopped: Both the sponsors and collaborator are considering terminating the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Collection of Peripheral Blood Mononuclear Cells by Means of ApheresisStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Legend Biotechnology Co.,Ltd.
- Responsible party
- Principal investigator, WEI XU, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Wei Xu, PhD& MD, Principal investigator, The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027855
- Sponsor's protocol ID
- BM2L201903
- Status last verified
- Dec 2021
- First submitted
- 19 Jul 2019
- Last updated
- 10 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Collection of Peripheral Blood Mononuclear Cells From Healthy Volunteers for the Development of Allogeneic Cellular Immunotherapy Products
- ClinicalTrials.gov ID
- NCT04027855
- Acronym / sponsor ID
- BM2L201903
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Both the sponsors and collaborator are considering terminating the study
- Enrolment
- 4 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Nanjing Legend Biotechnology Co.,Ltd.
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 9 Dec 2021 (actual)
- Study completion
- 9 Dec 2021 (actual)
- First posted
- 22 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- Apheresis period: 5 volunteers who meet the inclusion criteria will undergo collection of peripheral blood mononuclear cells (PBMC) by means of apheresis.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| collection of PBMC from healthy donors | Other | Procedure: collection of peripheral blood mononuclear cells from healthy volunteers1. 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years and ≤ 40 years, male or female;
- Weight: male ≥ 50 kg, female ≥ 45 kg; 18.5 ≤ BMI ≤ 30;
- Healthy volunteers who signed informed consent form.
Key exclusion criteria (24 listed)
- Those with known respiratory, circulatory, digestive, urinary, blood, immune, endocrine disorders or metabolic disorders;
- 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;
- Those with known chronic skin diseases, especially infectious, allergic or inflammatory systemic skin diseases;
- Those with known allergic diseases or recurrent allergies;
- Those with known malignant tumors or health-affecting benign tumors;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collection of peripheral blood mononuclear cells from healthy volunteers1. 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 or surgery | collection of PBMC from healthy donors |
Primary outcome
the number of PBMC
Time frame: two year
Results and safety
The study was stopped early (reason given: Both the sponsors and collaborator are considering terminating the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Xu, PhD& MD principal investigator
The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing collection of peripheral blood mononuclear cells from healthy volunteers in people with Collection of Peripheral Blood Mononuclear Cells by Means of Apheresis, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Both the sponsors and collaborator are considering terminating the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of PBMC (time frame: two year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2022.