Peripheral Blood Mononuclear Cell DonationNCT04091906
PBMC Donation in UCAR-T Cells
A study testing Peripheral blood mononuclear cell apheresis in people with Peripheral Blood Mononuclear Cell Donation, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Peripheral blood mononuclear cell donation protocol for tumor immunotherapy study of UCAR-T cells 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 Donation
- 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
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2019to 30 Jun 2020
- 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
- Male or female aged 18-40 years, no donation reaction in the past;
- Weight: male ≥ 50 kg, female ≥ 45 kg, and 18.5 kg/m2 ≤ BMI ≤ 30 kg/m2;
- Blood pressure:
- 12.0 Kpa (90 mmHg) ≤ systolic pressure﹤18.7 Kpa (140 mmHg) 8.0 Kpa (60 mmHg) ≤ diastolic pressure﹤12.0 Kpa (90 mmHg) Pulse pressure ≥ 4.0Kpa (30mmHg); 4) Pulse: 60/min to 100/min. Athletes with high endurance ≥ 50/min, with regular rhythm; 5) Temperature: 36.3-37.2℃ (oral temperature); 6) Generally in good condition: no damage to important organs such as heart, lung, liver and kidney; no severe or uncontrolled infection; no history of severe mental disorders; 7) Clinical examination should meet the following criteria:
- Hemoglobinometry: male ≥ 120g/L; female ≥ 110g/L. If using copper sulfate method: male ≥ 1.0520, female ≥ 1.0510
- White blood cell (WBC) test: ≥4×109/L
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- Alanine aminotransferase (ALT) ≤40U/L (Rate method), ≤25U/L (Reitman-Frankel method)
- Hepatitis B virus surface antigen (HBsAg) negative
- Hepatitis C virus antibody (HCV antibody) negative
- Human immunodeficiency virus antibody (HIV-1 and HIV-2 antibody) negative
- Syphilis negative
- Cytomegalovirus antibody (CMV antibody) negative
- Epstein-Barr virus antibody (EBV antibody) negative
Who cannot join
- Donors are ineligible to donate PBMC under the following circumstances:
- 1) Valetudinarian, with frequent dizziness, giddiness, tinnitus, hemophobia, fear of needles, faint, and Meniere's disease; 2) Sexually transmitted diseases (STDs), leprosy, AIDS, and HIV-1, HIV-2, CMV, EBV antibody positive; 3) History of liver diseases, HBsAg positive and HCV antibody positive. 1 year after the clinical cure of hepatitis A, normal ALT test results at 1 month interval for 3 consecutive times; 4) Relapsed allergic diseases, urticaria, bronchial asthma and drug allergies (Donors with simple urticaria who are not in acute attack are eligible to donate PBMC); 5) Pulmonary tuberculosis, renal tuberculosis, lymph node tuberculosis and bone tuberculosis; 6) Cardiovascular disease and history, various heart diseases, hypertension, hypotension, myocarditis and thrombophlebitis; 7) Respiratory diseases (including chronic bronchitis, emphysema, bronchiectasis and pulmonary insufficiency); 8) Digestive system diseases (e.g. severe gastric and duodenal ulcers, chronic gastroenteritis and chronic pancreatitis); 9) Urinary system diseases (e.g. acute and chronic nephritis, chronic urinary system infection, nephrotic syndrome, acute and chronic renal insufficiency, etc.); 10) Various hematological diseases (including anemia, leukemia, polycythemia vera and various hemorrhagic and coagulative diseases); 11) Endocrine diseases or metabolic disorders (e.g. hyperthyroidism, acromegaly, diabetes insipidus, diabetes mellitus, etc.); 12) Organic nervous system diseases or psychoses (e.g. encephalitis, sequelae of brain trauma, epilepsy, schizophrenia, hysteria, severe neurasthenia, etc.); 13) Parasitic diseases and endemic diseases (e.g. kala-azar, schistosomiasis, filariasis, hookworm disease, taeniasis, paragonimiasis, Keshan disease, Kaschin-Beck disease, etc.); 14) Malignancies and benign tumors affecting health; 15) History of haematological malignancies (e.g. leukaemia, lymphoma, myeloma), history of malignancies known to be associated with viraemic conditions (except for carcinoma in situ of the cervix). For other cancers, the donors should have fully recovered with no expectation of recurrence (i.e. cured) and the following conditions apply:
- for cancers with negligible metastatic potential (e.g. basal cell carcinoma and carcinoma in situ of the cervix), the donors may be accepted immediately following successful removal and cure
- for all other cancers, at least 5 years should have elapsed since completion of active treatment 16) Undergone resection of stomach, kidney, gallbladder, spleen, lung and other important organs; 17) Exposure to harmful substances or radioactive substances (except for clinical radiology); 18) High-risk groups susceptible to HIV infection, such as drug users, homosexuals and people with multiple sexual partners; 19) Creutzfeldt-Jakob disease (CJD), variant Creutzfeldt disease (vCJD), family history, and treatment with human and animal pituitary-derived substances (e.g. growth hormone, gonadotropin, thyrotropin, etc.). Organ transplantation recipients (including cornea, bone marrow, dura mater) may be exposed to bovine spongiform encephalopathy (BSE) and vCJD; 20) Chronic skin diseases, especially infectious, allergic and inflammatory systemic skin diseases (e.g. favus, generalized eczema, systemic psoriasis, etc.); 21) Autoimmune diseases and collagenosis (e.g. systemic lupus erythematosus, dermatomyositis, scleroderma, etc.); 22) Bitten by animals carrying rabies virus; 23) Other diseases or conditions in which donors are ineligible to donate PBMC in the opinion of physicians;
- Donors should be deferred for the time being under the following circumstances:
- Tooth extraction or other minor surgery within half a month;
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- 3 days before or after menstruation, menstrual disorders, pregnancy, less than 6 months after abortion, less than 1 year after delivery and lactation;
- Less than 1 week after the recovery of cold and acute gastroenteritis, less than 1 month after the cure of acute urinary system infection, and less than half a year after the cure of pneumonia;
- Donors from high-risk areas of infectious diseases as prescribed by certain infectious diseases and epidemic prevention departments. Less than half a year after the cure of dysentery, less than 1 year after the cure of typhoid fever and brucellosis, history of malaria within 3 years;
- Within 2 years after blood transfusion treatment;
- Less than 1 year after tattoo, injuries or contaminated wounds caused by equipment contaminated by blood or tissue fluid;
- Close contact history with patients with infectious diseases: within the longest incubation period of the disease after the date of contact;
- Recipients of animal serum products: within 4 weeks after the last injection;
- Recipients of hepatitis B immunoglobulin (HBIG) injection: within 1 year;
- Provisions for PBMC collection after immunization:
- 1) Asymptomatic donors who have recently received immunization may donate PBMC only after the following period of time: 2 weeks after the last immunization of measles, mumps, yellow fever, poliomyelitis and live attenuated hepatitis A vaccine, 4 weeks after the last immunization of live rubella vaccine and rabies vaccine;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000
Jianyong Li, PhD, lijianyonglm@126.com
About this study
Official title: Peripheral Blood Mononuclear Cell Donation Protocol for Tumor Immunotherapy Study of UCAR-T Cells
Peripheral blood mononuclear cell donation protocol for tumor immunotherapy study of UCAR-T cells
- 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 mononuclear cell donation for tumor immunotherapy study of UCAR-T cells
| Study group | Role | What they receive |
|---|---|---|
| Healthy donor | Experimental | 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.
Collect blood samples
Collect blood samples (whole blood and PBMC) from healthy donors for the development and production of UCAR-T cells
Measured: Baseline
Secondary outcomes (1)
Collect blood samples
Collect blood samples (whole blood) for pre-preparation of autologous CAR-T cells, comparation with UCAR-T products, exploration of the differences in cell expansion and function between UCAR-T and autologous CAR-T, and pre-experiments in the development of various test methodologies
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completion31 Mar 2020 (estimated)
- Study completion30 Jun 2020 (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 Cell DonationStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Bioheng Biotech Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091906
- Sponsor's protocol ID
- JSPH-CTA101-PBMC
- Status last verified
- Sep 2019
- First submitted
- 15 Sep 2019
- Last updated
- 17 Sep 2019
- 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 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Blood Mononuclear Cell Donation Protocol for Tumor Immunotherapy Study of UCAR-T Cells
- ClinicalTrials.gov ID
- NCT04091906
- Acronym / sponsor ID
- JSPH-CTA101-PBMC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Nanjing Bioheng Biotech Co., Ltd.
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 17 Sep 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.
Peripheral blood mononuclear cell donation protocol for tumor immunotherapy study of UCAR-T cells
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 | Experimental | 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 (13 listed)
- Male or female aged 18-40 years, no donation reaction in the past;
- Weight: male ≥ 50 kg, female ≥ 45 kg, and 18.5 kg/m2 ≤ BMI ≤ 30 kg/m2;
- Blood pressure:
- 12.0 Kpa (90 mmHg) ≤ systolic pressure﹤18.7 Kpa (140 mmHg) 8.0 Kpa (60 mmHg) ≤ diastolic pressure﹤12.0 Kpa (90 mmHg) Pulse pressure ≥ 4.0Kpa (30mmHg); 4) Pulse: 60/min to 100/min. Athletes with high endurance ≥ 50/min, with regular rhythm; 5) Temperature: 36.3-37.2℃ (oral temperature); 6) Generally in good condition: no damage to important organs such as heart, lung, liver and kidney; no severe or uncontrolled infection; no history of severe mental disorders; 7) Clinical examination should meet the following criteria:
- Hemoglobinometry: male ≥ 120g/L; female ≥ 110g/L. If using copper sulfate method: male ≥ 1.0520, female ≥ 1.0510
Key exclusion criteria (16 listed)
- 1) Valetudinarian, with frequent dizziness, giddiness, tinnitus, hemophobia, fear of needles, faint, and Meniere's disease; 2) Sexually transmitted diseases (STDs), leprosy, AIDS, and HIV-1, HIV-2, CMV, EBV antibody positive; 3) History of liver diseases, HBsAg positive and HCV antibody positive. 1 year after the clinical cure of hepatitis A, normal ALT test results at 1 month interval for 3 consecutive times; 4) Relapsed allergic diseases, urticaria, bronchial asthma and drug allergies (Donors with simple urticaria who are not in acute attack are eligible to donate PBMC); 5) Pulmonary tuberculosis, renal tuberculosis, lymph node tuberculosis and bone tuberculosis; 6) Cardiovascular disease and history, various heart diseases, hypertension, hypotension, myocarditis and thrombophlebitis; 7) Respiratory diseases (including chronic bronchitis, emphysema, bronchiectasis and pulmonary insufficiency); 8) Digestive system diseases (e.g. severe gastric and duodenal ulcers, chronic gastroenteritis and chronic pancreatitis); 9) Urinary system diseases (e.g. acute and chronic nephritis, chronic urinary system infection, nephrotic syndrome, acute and chronic renal insufficiency, etc.); 10) Various hematological diseases (including anemia, leukemia, polycythemia vera and various hemorrhagic and coagulative diseases); 11) Endocrine diseases or metabolic disorders (e.g. hyperthyroidism, acromegaly, diabetes insipidus, diabetes mellitus, etc.); 12) Organic nervous system diseases or psychoses (e.g. encephalitis, sequelae of brain trauma, epilepsy, schizophrenia, hysteria, severe neurasthenia, etc.); 13) Parasitic diseases and endemic diseases (e.g. kala-azar, schistosomiasis, filariasis, hookworm disease, taeniasis, paragonimiasis, Keshan disease, Kaschin-Beck disease, etc.); 14) Malignancies and benign tumors affecting health; 15) History of haematological malignancies (e.g. leukaemia, lymphoma, myeloma), history of malignancies known to be associated with viraemic conditions (except for carcinoma in situ of the cervix). For other cancers, the donors should have fully recovered with no expectation of recurrence (i.e. cured) and the following conditions apply:
- for cancers with negligible metastatic potential (e.g. basal cell carcinoma and carcinoma in situ of the cervix), the donors may be accepted immediately following successful removal and cure
- for all other cancers, at least 5 years should have elapsed since completion of active treatment 16) Undergone resection of stomach, kidney, gallbladder, spleen, lung and other important organs; 17) Exposure to harmful substances or radioactive substances (except for clinical radiology); 18) High-risk groups susceptible to HIV infection, such as drug users, homosexuals and people with multiple sexual partners; 19) Creutzfeldt-Jakob disease (CJD), variant Creutzfeldt disease (vCJD), family history, and treatment with human and animal pituitary-derived substances (e.g. growth hormone, gonadotropin, thyrotropin, etc.). Organ transplantation recipients (including cornea, bone marrow, dura mater) may be exposed to bovine spongiform encephalopathy (BSE) and vCJD; 20) Chronic skin diseases, especially infectious, allergic and inflammatory systemic skin diseases (e.g. favus, generalized eczema, systemic psoriasis, etc.); 21) Autoimmune diseases and collagenosis (e.g. systemic lupus erythematosus, dermatomyositis, scleroderma, etc.); 22) Bitten by animals carrying rabies virus; 23) Other diseases or conditions in which donors are ineligible to donate PBMC in the opinion of physicians;
- Tooth extraction or other minor surgery within half a month;
- 3 days before or after menstruation, menstrual disorders, pregnancy, less than 6 months after abortion, less than 1 year after delivery and lactation;
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 mononuclear cell donation for tumor immunotherapy study of UCAR-T cells | Device | Healthy donor |
Primary outcome
Collect blood samples
Time frame: Baseline
Collect blood samples (whole blood and PBMC) from healthy donors for the development and production of UCAR-T cells
1 secondary outcome
Collect blood samples
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
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Healthy Volunteer
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 Donation, 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 13 inclusion and 16 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 17 Sep 2019. 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 Jianyong Li, Ph.D. (025-83718836, lijianyonglm@126.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: Baseline). 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 17 Sep 2019.