Healthy SubjectNCT04295096
Collection of PBMCs From Healthy Subjects for the Development of Cellular Immunotherapy Product
A study testing Peripheral blood mononuclear cell apheresis in people with Healthy Subject, run by Jun Zhu at 1 site in China.
Trial summary
Title: Collection of Peripheral Blood Mononuclear Cells (PBMCs) From Healthy Subjects for the Development of Cellular Immunotherapy Product Background: CAR-T therapies are being developed that utilize modified immune cells to fight tumors. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subject
- 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
- 172 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2020to Mar 2024
- 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
- 18 to 40 years of age
- Male≥50 kg, female≥45 kg with 18.5≤ BMI ≤30
- Subject has provided informed consent
Who cannot join
- Subject has respiratory diseases, circulatory system diseases, digestive system diseases, urinary system diseases, hematological system diseases, autoimmune diseases, endocrine disorders or metabolic disorders;
- Subject has nervous system diseases, mental illness, Creutzfeldt-Jakob disease or those with a family history, or those treated with tissue or tissue derivatives that may be derived from Creutzfeldt-Jakob infected people;
- Subject has chronic skin diseases, especially infectious, allergic or inflammatory systemic skin diseases;
- Subject has allergic diseases or recurrent allergies;
- Malignant tumors or health-affecting benign tumors;
- Twice or more times of blood pressure measurement exhibit (except for white coat hypertension): systolic blood pressure < 90 or ≥ 140 Millimeter of mercury (mm Hg), or diastolic blood pressure < 60 or ≥ 90 mm Hg, or pulse pressure < 30 mm Hg, heart rate: < 60 beats/min or >100 beats/min;
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- Laboratory tests: hemoglobin: male <120 g/L, female <115 g/L, or liver and kidney laboratory result >1.5x upper limit of normal with clinical significant, or abnormal12-lead ECG with clinical significant, or abnormal abdominal B-mode ultrasound with clinical significant, or abnormal chest X-ray with clinical significant, and T cell detection of tuberculosis infection is over the limit or positive;
- Abnormal lymphocyte subset panel test result with clinical significance (Lymphs%, CD3+, CD3+CD4+, CD3+CD8+, CD3-CD16+CD56+,CD19+) ;
- Hepatitis B surface antigen positive, hepatitis B virus (HBV) DNA positive, hepatitis B e antigen positive, hepatitis C antibody positive, Treponema pallidum antibody positive ,human immunodeficiency virus antibody positive, human T-cell lymphotrophic virus antibody positive, Epstein-Barr virus positive, or COVID-19 nucleic acid positive ;
- Recipient of organ transplant;
- Received any major organ resection such as stomach, kidney, spleen and lung;
- Subject has transfusion-associated infectious diseases;
- Minor surgery within 3 months, such as appendectomy and recovered ophthalmic surgery; Major surgery within l 1 year, such as surgical treatment for gynecological benign tumors or superficial benign tumors;
- Pregnant, or have an abortion within l 6 months, childbirth within 1 year;
- Upper respiratory infection recovered within 1 week, or pneumonia recovered within 3 months;
- Acute pyelonephritis-recovered within 3 months, or urinary calculi onset;
- Injured or wound-contaminated by equipment contaminated by blood or tissue fluids, or has a tattoo within 1 year;
- Received whole blood and blood component transfusion within 1 year;
- Received the last vaccination of live attenuated vaccines such as measles, mumps, or polio within 2 weeks, or the last vaccination of rubella live vaccine, human rabies vaccine, live attenuated Japanese encephalitis vaccine within 4 weeks;
- Received the last vaccination of rabies vaccines after being bitten by an animal within 1 year;
- Received the last vaccination of antitoxin or immune serum injection within 4 weeks, or those who received the last vaccination of hepatitis B human immunoglobulin injection within 1 year;
- Participated in a clinical trials within 1 month; it should be discussed case by base if investigational product used.
- 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
Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai
Shanghai
Jun Zhu, M.D.
About this study
Official title: Collection of Peripheral Blood Mononuclear Cells From Healthy Subjects for the Development of Cellular Immunotherapy Product
Title: Collection of Peripheral Blood Mononuclear Cells (PBMCs) From Healthy Subjects for the Development of Cellular Immunotherapy Product
Background:
CAR-T therapies are being developed that utilize modified immune cells to fight tumors. 'Off-the-shelf' allogeneic CAR-T technology has better efficacy and more promising clinical applications. Investigators want to use the cells of healthy subjects to perform the studies. To accomplish this, they are collecting PBMCs through apheresis.
Objectives:
To collect PBMCs from healthy subjects for product development for cell Immunotherapies.
Read the detailed description
Background:
Autologous chimeric antigen receptor (CAR) T cells have changed the therapeutic landscape in haematological malignancies. Nevertheless, the use of allogeneic CAR T cells from donors has many potential advantages over autologous approaches, such as the immediate availability of cryopreserved batches for patient treatment, possible standardization of the CAR-T cell product, time for multiple cell modifications, redosing or combination of CAR T cells directed against different targets, and decreased cost using an industrialized process. The T cells currently used for CAR-T cell manufacturing are mainly derived from peripheral blood mono-nuclear cells (PBMCs) .The manufacture of allogeneic CAR T cells from PBMCs collected from healthy donors is associated with the ability to make multiple vials from a single apheresis product. Allogeneic CAR T cells are created from healthy donors, they are generated from immune cells that have not been impacted by the immune effects of cancer or by exposure to chemotherapeutic agents, in contrast to autologous T cells from patients. The selection of donors on the basis of their immune characteristics is likely to be a key factor in decreasing the heterogeneity of the final cell product
Objectives:
- To produce allogeneic CAR T cells with different targets and other cell products by using PBMCs from healthy subjects.
- To develop and optimize the methodology for the response or quality determination of cell Immunotherapy products.
Design:
All subjects are required to sign a written informed consent form for the study. After the signing of informed consent form, participants will be screened with a series of vital signs, physical examinations and laboratory tests. Demographic data and medical history of the subjects will also be documented. In addition, 30 mL peripheral venous blood sample will be collected to evaluate the biological characteristics of each subject. Participants will undergo a routine blood test within 24 hours before the apheresis to reconfirm their eligibility and 3-5 mL blood samples are to be drawn for the development of detection methods of cell-based immunotherapy. Subjects who meet all the inclusion criteria and do not meet any exclusion criteria are qualified to donate peripheral blood mono-nuclear cells (PBMCs) by means of apheresis. 6×10[9] of cells for each healthy person are preferred. 172 healthy subjects are to be enrolled through the whole study.
- Conditions
- Healthy Subject
- 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
Peripheral blood mono-nuclear cell donation for tumor immunotherapy study of Universal CAR-T cells
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Other | Healthy donor Receives: Device: Peripheral blood mononuclear cell apheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect blood samples
Collect blood samples (whole blood and PBMC) from healthy subjects for the Development of Cellular Immunotherapy Product.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start1 Apr 2020
- Primary completionFeb 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectStudies of the same condition, open and under way.
- 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
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jun Zhu
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Legend Biotech Co.
- Responsible party
- Sponsor-investigator, Jun Zhu, Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai
- Investigators
- Jun Zhu, M.D., Principal investigator, Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295096
- Sponsor's protocol ID
- BM2L201909
- Status last verified
- Jun 2021
- First submitted
- 2 Mar 2020
- Last updated
- 9 Jun 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 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Peripheral Blood Mononuclear Cells From Healthy Subjects for the Development of Cellular Immunotherapy Product
- ClinicalTrials.gov ID
- NCT04295096
- Acronym / sponsor ID
- BM2L201909
- Conditions
- Healthy Subject
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Jun ZhuUniversity, hospital or other
- Collaborators
- Nanjing Legend Biotech Co.
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 4 Mar 2020 (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.
Title: Collection of Peripheral Blood Mononuclear Cells (PBMCs) From Healthy Subjects for the Development of Cellular Immunotherapy Product
Background:
CAR-T therapies are being developed that utilize modified immune cells to fight tumors. 'Off-the-shelf' allogeneic CAR-T technology has better efficacy and more promising clinical applications. Investigators want to use the cells of healthy subjects to perform the studies. To accomplish this, they are collecting PBMCs through apheresis.
Objectives:
To collect PBMCs from healthy subjects for product development for cell Immunotherapies.
Detailed description
Background:
Autologous chimeric antigen receptor (CAR) T cells have changed the therapeutic landscape in haematological malignancies. Nevertheless, the use of allogeneic CAR T cells from donors has many potential advantages over autologous approaches, such as the immediate availability of cryopreserved batches for patient treatment, possible standardization of the CAR-T cell product, time for multiple cell modifications, redosing or combination of CAR T cells directed against different targets, and decreased cost using an industrialized process. The T cells currently used for CAR-T cell manufacturing are mainly derived from peripheral blood mono-nuclear cells (PBMCs) .The manufacture of allogeneic CAR T cells from PBMCs collected from healthy donors is associated with the ability to make multiple vials from a single apheresis product. Allogeneic CAR T cells are created from healthy donors, they are generated from immune cells that have not been impacted by the immune effects of cancer or by exposure to chemotherapeutic agents, in contrast to autologous T cells from patients. The selection of donors on the basis of their immune characteristics is likely to be a key factor in decreasing the heterogeneity of the final cell product
Objectives:
- To produce allogeneic CAR T cells with different targets and other cell products by using PBMCs from healthy subjects.
- To develop and optimize the methodology for the response or quality determination of cell Immunotherapy products.
Design:
All subjects are required to sign a written informed consent form for the study. After the signing of informed consent form, participants will be screened with a series of vital signs, physical examinations and laboratory tests. Demographic data and medical history of the subjects will also be documented. In addition, 30 mL peripheral venous blood sample will be collected to evaluate the biological characteristics of each subject. Participants will undergo a routine blood test within 24 hours before the apheresis to reconfirm their eligibility and 3-5 mL blood samples are to be drawn for the development of detection methods of cell-based immunotherapy. Subjects who meet all the inclusion criteria and do not meet any exclusion criteria are qualified to donate peripheral blood mono-nuclear cells (PBMCs) by means of apheresis. 6×10[9] of cells for each healthy person are preferred. 172 healthy subjects are to be enrolled through the whole study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Other | Device: Peripheral blood mononuclear cell apheresisHealthy donor |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 to 40 years of age
- Male≥50 kg, female≥45 kg with 18.5≤ BMI ≤30
- Subject has provided informed consent
Key exclusion criteria (23 listed)
- Subject has respiratory diseases, circulatory system diseases, digestive system diseases, urinary system diseases, hematological system diseases, autoimmune diseases, endocrine disorders or metabolic disorders;
- Subject has nervous system diseases, mental illness, Creutzfeldt-Jakob disease or those with a family history, or those treated with tissue or tissue derivatives that may be derived from Creutzfeldt-Jakob infected people;
- Subject has chronic skin diseases, especially infectious, allergic or inflammatory systemic skin diseases;
- Subject has allergic diseases or recurrent allergies;
- 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 |
|---|---|---|
| Peripheral blood mononuclear cell apheresisPeripheral blood mono-nuclear cell donation for tumor immunotherapy study of Universal CAR-T cells | Device | Experimental |
Primary outcome
Collect blood samples
Time frame: 2 years
Collect blood samples (whole blood and PBMC) from healthy subjects for the Development of Cellular Immunotherapy Product.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Jun Zhu, M.D. principal investigator
Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai
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 Healthy Subject, run by Jun Zhu 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 23 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 9 Jun 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 Jun Zhu, M.D. (+86-021-36561999 ext. 8020, zhuj@bohuhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collect blood samples (time frame: 2 years). 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 9 Jun 2021.