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

Study Overview
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Brief Summary
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Peripheral blood mononuclear cell collection protocol for tumor immunotherapy study of UCAR-T cells

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

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

Conditions
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Peripheral Blood Mononuclear Cell

Intervention / Treatment
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* Other: Peripheral blood mononuclear cell apheresis


Participation Criteria
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Eligibility Criteria
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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 pressure﹤18.7 Kpa (140 mmHg) 8.0 Kpa (60 mmHg) ≤ diastolic pressure﹤12.0 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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy donor<br>Healthy donor | Other: Peripheral blood mononuclear cell apheresis<br>* Peripheral blood mononuclear cell collection for tumor immunotherapy study of UCAR-T cells<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of PBMC count | UCAR-T cell | 1 years |