Peripheral Blood Mononuclear Cell
Conditions
Brief summary
Peripheral blood mononuclear cell collection protocol for tumor immunotherapy study of UCAR-T cells
Detailed description
Collect blood samples (whole blood and PBMC) from healthy donors for the development and production of UCAR-T cells
Interventions
Peripheral blood mononuclear cell collection for tumor immunotherapy study of UCAR-T cells
Sponsors
Nanjing Bioheng Biotech Co., Ltd.
He Huang
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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 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;
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the number of PBMC count | 1 years | UCAR-T cell |
Countries
China
Contacts
Primary ContactHe Huang, PhD
Backup ContactJimin Shi, MD
Outcome results
None listed