TrialX
Image

Peripheral Blood Mononuclear Cell Collection Protocol for UCART Cell Tumor Immunotherapy Study

Peripheral Blood Mononuclear Cell Collection Protocol for UCART Cell Tumor Immunotherapy Study

Recruiting
18-40 years
All
Phase N/A

Overview

Peripheral blood mononuclear cell collection protocol for tumor immunotherapy study of UCAR-T cells

Description

Collect blood samples (whole blood and PBMC) from healthy donors for the development and production of UCAR-T cells

Eligibility

Inclusion Criteria:

  1. Male or female aged 18-40 years, no donation reaction in the past;
  2. Weight: male 50 kg, female 45 kg, and 18.5 kg/m2 BMI 30 kg/m2;
  3. Blood pressure:12.0 Kpa (90 mmHg) systolic pressure18.7 Kpa (140 mmHg) 8.0 Kpa (60 mmHg) diastolic pressure12.0 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;

Exclusion Criteria:

  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. Urinary system diseases (e.g. acute and chronic nephritis, chronic urinary system infection, nephrotic syndrome, acute and chronic renal insufficiency, etc.);
  7. Various hematological diseases (including anemia, leukemia, polycythemia vera and various hemorrhagic and coagulative diseases);
  8. Endocrine diseases or metabolic disorders (e.g. hyperthyroidism, acromegaly, diabetes insipidus, diabetes mellitus, etc.);
  9. Organic nervous system diseases or psychoses (e.g. encephalitis, sequelae of brain trauma, epilepsy, schizophrenia, hysteria, severe neurasthenia, etc.);
  10. Parasitic diseases and endemic diseases (e.g. kala-azar, schistosomiasis, filariasis, hookworm disease, taeniasis, paragonimiasis, Keshan disease, Kaschin-Beck disease, etc.);
  11. Malignancies and benign tumors affecting health;
  12. Undergone resection of stomach, kidney, gallbladder, spleen, lung and other important organs;
  13. Exposure to harmful substances or radioactive substances (except for clinical radiology);
  14. High-risk groups susceptible to HIV infection, such as drug users, homosexuals and people with multiple sexual partners;
  15. 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;
  16. Other diseases or conditions in which donors are ineligible to donate PBMC in the opinion of physicians;

Study details
    Peripheral Blood Mononuclear Cell

NCT04448509

He Huang

5 August 2020

Step 1 Get in touch with the nearest study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team


Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.