Peripheral Blood Mononuclear CellNCT04963959
PBMC Collection for Production of UCAR T Cells
A study testing Peripheral blood mononuclear cell apheresis in people with Peripheral Blood Mononuclear Cell, run by The First Affiliated Hospital of Soochow 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 production of UCAR T cells used for Clinical trails. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Blood Mononuclear Cell
- What is being tested?
- Peripheral blood mononuclear cell apheresis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 14 Jul 2021to 31 Jan 2022
- 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
- Healthy volunteers who signed informed consent form
- Age ≥ 18 years and ≤ 40 years, male or female, Han nationality.
- Weight: male ≥ 50 kg, female ≥ 45 kg; 18.5 ≤ BMI ≤ 30.
- Temperature: 36.3-37.2℃ (Forehead temperature).
Who cannot join
- Those with known respiratory, circulatory, digestive, urinary, blood, immune, endocrine disorders or metabolic disorders, neurological diseases, mental illnesses and those with a family history;
- 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 < 30 mmHg, heart rate: < 60 beats/min or >100 beats/min;
- Laboratory tests: hemoglobin is abnormal and has clinical significant; liver and kidney function are higher than the normal upper limit and have clinical significance; 12-lead ECG is abnormal and has clinical significance, or abdominal ultrasound is abnormal and has clinical significance, or chest X-ray is abnormal and has clinical significance; abnormal coagulation function; increased CRP;
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- Those with active or latent hepatitis B or active hepatitis C, or Treponema pallidum antibody, or human immunodeficiency virus antibody, or anti-EBV IgM antibody, or anti-CMV IgM antibody, or COVID-19 DNA ;
- Recipients of allogeneic tissue and organ or hematopoietic stem cell transplants;
- Those who have undergone resection of vital internal organs such as stomach, kidney, spleen and lung;
- Those who have undergone minor surgery within last 3 months, such as appendectomy and ophthalmic surgery; those who have undergone major surgery within 1 year, such as surgical treatment for gynecological benign tumors or superficial benign tumors;
- Women who are pregnant, or have an abortion within last 6 months or gave childbirth within 1 year;
- 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 dose of live attenuated vaccines within 2 weeks, or have received the last dose of rubella live vaccine within 4 weeks;
- Those who have received the last dose of rabies vaccines after being bitten by an animal within 1 year;
- Those who have received the last dose of antitoxin or immune serum injection within 4 weeks, or those who have received the last dose of hepatitis B human immunoglobulin injection within 1 year;
- Those who have participated in clinical trials within 3 months, or try to participate in other intervention trials during the study.
- 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, 1 recruiting
- Recruiting
First Affiliated Hospital, Soochow University
Suzhou, Jiangsu, 215000
Fu chengcheng, Phd, 13962191404, fuzhengzheng@suda.edu.cn
About this study
Official title: A Study on the Collection of Peripheral Blood Mononuclear Cells From Healthy Volunteers for UCAR T Production and Clinical Investigation
The objective of the study is to collect peripheral blood mononuclear cells (PBMC) from healthy volunteers for the research and production of UCAR T cells used for Clinical trails.
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 will receive peripheral venous whole blood sampling, and the volunteers receiving apheresis based on the assessment results will be enrolled.
- Apheresis period: 25 volunteers who meet the inclusion criteria will undergo collection of peripheral blood mononuclear cells (PBMC) by means of apheresis.
- Conditions
- Peripheral Blood Mononuclear Cell
- Being tested
- Peripheral blood mononuclear cell apheresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral blood mononuclear cell apheresisDevice
mononuclear cell donation for tumor immunotherapy study of UCAR-T cells
| Study group | Role | What they receive |
|---|---|---|
| Healthy donor | Other | Not described Receives: Device: Peripheral blood mononuclear cell apheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of peripheral blood mononuclear cells (PBMC
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start14 Jul 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Blood Mononuclear CellStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- CARsgen Therapeutics Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963959
- Sponsor's protocol ID
- CT0590-CG6011
- Status last verified
- Jun 2021
- First submitted
- 6 Jul 2021
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. 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 UCAR T Production and Clinical Investigation
- ClinicalTrials.gov ID
- NCT04963959
- Acronym / sponsor ID
- CT0590-CG6011
- Conditions
- Peripheral Blood Mononuclear Cell
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- CARsgen Therapeutics Co., Ltd.
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 15 Jul 2021 (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 production of UCAR T cells used for Clinical trails.
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 will receive peripheral venous whole blood sampling, and the volunteers receiving apheresis based on the assessment results will be enrolled.
- Apheresis period: 25 volunteers who meet the inclusion criteria will undergo collection of peripheral blood mononuclear cells (PBMC) by means of apheresis.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy donor | Other | Device: Peripheral blood mononuclear cell apheresis |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy volunteers who signed informed consent form
- Age ≥ 18 years and ≤ 40 years, male or female, Han nationality.
- Weight: male ≥ 50 kg, female ≥ 45 kg; 18.5 ≤ BMI ≤ 30.
- Temperature: 36.3-37.2℃ (Forehead temperature).
Key exclusion criteria (20 listed)
- Those with known respiratory, circulatory, digestive, urinary, blood, immune, endocrine disorders or metabolic disorders, neurological diseases, mental illnesses and those with a family history;
- 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 < 30 mmHg, heart rate: < 60 beats/min or >100 beats/min;
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 |
|---|---|---|
| Peripheral blood mononuclear cell apheresismononuclear cell donation for tumor immunotherapy study of UCAR-T cells | Device | Healthy donor |
Primary outcome
The number of peripheral blood mononuclear cells (PBMC
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral blood mononuclear cell apheresis in people with Peripheral Blood Mononuclear Cell, run by The First Affiliated Hospital of Soochow 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 4 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 4 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact chengcheng Fu (+86 13962191404, fuchengchengsz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of peripheral blood mononuclear cells (PBMC (time frame: 2 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 4 Nov 2021.