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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Jianyong Li, Ph.D. contact

025-83718836

lijianyonglm@126.com

China1 site, 1 recruiting
  • the First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210000

    Jianyong Li, PhD, lijianyonglm@126.com

    Recruiting

Other trials in China

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 groups in NCT04091906
Study groupRoleWhat they receive
Healthy donorExperimentalNot 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.

  1. 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)
  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.

  1. First posted17 Sep 2019
  2. Study start1 Oct 2019 (estimated)
  3. Primary completion31 Mar 2020 (estimated)
  4. Study completion30 Jun 2020 (estimated)

Resources

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)
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

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.

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