A Study on the Collection of Peripheral Blood Mononuclear Cells From Healthy Volunteers for the Development of Allogeneic Cellular Immunotherapy Products

Exclusion Criteria

• •1. Those with known respiratory, circulatory, digestive, urinary, blood, immune, endocrine disorders or metabolic disorders;
• •2. Those with known neurological diseases, mental illnesses, Creutzfeldt-Jakob disease and those with a family history, or those treated with tissue or tissue derivatives that may be derived from Creutzfeldt-Jakob infected people;
• •3. Those with known chronic skin diseases, especially infectious, allergic or inflammatory systemic skin diseases;
• •4. Those with known allergic diseases or recurrent allergies;
• •5. Those with known malignant tumors or health-affecting benign tumors;
• •6. Two or more physical examination results of blood pressure have shown (except for white coat hypertension): systolic blood pressure \< 90 or ≥ 140mmHg, or diastolic blood pressure \< 60 or ≥ 90 mmHg, or pulse pressure difference \< 30 mmHg, heart rate: \< 60 beats/min or \>100 beats/min;
• •7. Laboratory tests: hemoglobin determination: male \<120 g/L, female \<115 g/L, or liver and kidney function is more than 1.5 times the upper limit of normal and clinically significant, or 12-lead ECG is abnormal and clinically significant, or abdominal B-mode ultrasound is abnormal and clinically significant, or chest X-ray is abnormal and clinically significant, and T cell detection of tuberculosis infection is over the limit or positive;
• •8. lymphocyte subsets （lymphocyte proportion、CD3+、CD3+CD4+、CD3+CD8+、CD3-CD16+CD56+、CD19+）Abnormal detection and clinical significance;
• •9. Those with positive hepatitis B surface antigen or HBV DNA, or hepatitis B e antigen, or hepatitis C antibody, or Treponema pallidum antibody, or human immunodeficiency virus antibody;
• •10. Recipients of allogeneic tissue and organ transplants;
• •11. Those who have undergone resection of vital internal organs such as stomach, kidney, spleen and lung;
• •12. Those who have suffered from blood transfusion-associated infectious diseases;
• •13. Those who have undergone minor surgery within less than 3 months, such as appendectomy and ophthalmic surgery; those who have undergone major surgery within less than 1 year, such as surgical treatment for gynecological benign tumors or superficial benign tumors;
• •14. Women who are pregnant, or have an abortion within less than 6 months or have undergone less than 1 year after childbirth and lactation;
• •15. Those whose upper respiratory tract infection has recovered for less than 1 week, or pneumonia has recovered for less than 3 months;
• •16. Those whose acute pyelonephritis has recovered for less than 3 months, or those with acute exacerbation of urinary calculi;
• •17. Those who have been injured or wound-contaminated by equipment contaminated by blood or tissue fluids, or who have got a tattoo for less than 1 year;
• •18. Those who have received whole blood and blood component transfusion within 1 year;
• •19. Those who have received the last vaccination of live attenuated vaccines such as measles, mumps, or polio within 2 weeks, or have received the last vaccination of rubella live vaccine, human rabies vaccine, live attenuated Japanese encephalitis vaccine within 4 weeks;
• •20. Those who have received the last vaccination of rabies vaccines after being bitten by an animal within 1 year;
• •21. Those who have received the last vaccination of antitoxin or immune serum injection within 4 weeks, or those who have received the last vaccination of hepatitis B human immunoglobulin injection within 1 year;
• •22. Those who have participated in clinical trials within 1 month; if they have used investigational drugs, they need to be discussed case by case;
• •23. Those who cannot meet the basic biological indicators for UCAR-T product preparation, specifically including positive blood safety indicator sterility test result, or positive mycoplasma test result, or culture product endotoxin test ≥ 10 EU/mL; basic biological indicator cell viability is \< 70%, or the number of effective T lymphocytes cannot meet the needs of in vitro assessment, or the in vitro proliferative production characteristics of each component cell, or the proportion of each component cannot meet the UCAR-T preparation conditions;
• •24. Those who are considered by the investigator as unsuitable for participating in the study.