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

  • STATUS
    Recruiting
  • participants needed
    50
  • sponsor
    He Huang
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Updated on 19 February 2024
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Summary

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

Details
Condition Peripheral Blood Mononuclear Cell
Age 18-40 years
Treatment Peripheral blood mononuclear cell apheresis
Clinical Study IdentifierNCT04448509
SponsorHe Huang
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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 pressure18.7 Kpa (140 mmHg) 8.0 Kpa (60 mmHg) diastolic pressure12.0 Kpa (90 mmHg) Pulse pressure 4.0Kpa (30mmHg)
Pulse: 60/min to 100/min. Athletes with high endurance 50/min, with regular rhythm
Temperature: 36.3-37.2 (oral temperature)
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

Valetudinarian, with frequent dizziness, giddiness, tinnitus, hemophobia, fear of needles, faint, and Meniere's disease
Sexually transmitted diseases (STDs), leprosy, AIDS, and HIV-1, HIV-2, CMV, EBV antibody positive
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
Relapsed allergic diseases, urticaria, bronchial asthma and drug allergies (Donors with simple urticaria who are not in acute attack are eligible to donate PBMC)
Pulmonary tuberculosis, renal tuberculosis, lymph node tuberculosis and bone tuberculosis
Urinary system diseases (e.g. acute and chronic nephritis, chronic urinary system infection, nephrotic syndrome, acute and chronic renal insufficiency, etc.)
Various hematological diseases (including anemia, leukemia, polycythemia vera and various hemorrhagic and coagulative diseases)
Endocrine diseases or metabolic disorders (e.g. hyperthyroidism, acromegaly, diabetes insipidus, diabetes mellitus, etc.)
Organic nervous system diseases or psychoses (e.g. encephalitis, sequelae of brain trauma, epilepsy, schizophrenia, hysteria, severe neurasthenia, etc.)
Parasitic diseases and endemic diseases (e.g. kala-azar, schistosomiasis, filariasis, hookworm disease, taeniasis, paragonimiasis, Keshan disease, Kaschin-Beck disease, etc.)
Malignancies and benign tumors affecting health
Undergone resection of stomach, kidney, gallbladder, spleen, lung and other important organs
Exposure to harmful substances or radioactive substances (except for clinical radiology)
High-risk groups susceptible to HIV infection, such as drug users, homosexuals and people with multiple sexual partners
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
Other diseases or conditions in which donors are ineligible to donate PBMC in the opinion of physicians
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