PBMC Donation in UCAR-T Cells

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) ≤ diastolicpressure﹤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 asheart, lung, liver and kidney; no severe or uncontrolled infection; no history of severemental disorders; 7) Clinical examination should meet the following criteria:

1. Hemoglobinometry: male ≥ 120g/L; female ≥ 110g/L. If using copper sulfate method: male ≥ 1.0520, female ≥ 1.0510

2. White blood cell (WBC) test: ≥4×109/L

3. Alanine aminotransferase (ALT) ≤40U/L (Rate method), ≤25U/L (Reitman-Frankel method)

4. Hepatitis B virus surface antigen (HBsAg) negative

5. Hepatitis C virus antibody (HCV antibody) negative

6. Human immunodeficiency virus antibody (HIV-1 and HIV-2 antibody) negative

7. Syphilis negative

8. Cytomegalovirus antibody (CMV antibody) negative

9. Epstein-Barr virus antibody (EBV antibody) negative

Exclusion Criteria: Donors are ineligible to donate PBMC under the following circumstances:

1. Valetudinarian, with frequent dizziness, giddiness, tinnitus, hemophobia, fear ofneedles, 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, HBsAgpositive and HCV antibody positive. 1 year after the clinical cure of hepatitis A, normalALT test results at 1 month interval for 3 consecutive times; 4) Relapsed allergicdiseases, urticaria, bronchial asthma and drug allergies (Donors with simple urticaria whoare not in acute attack are eligible to donate PBMC); 5) Pulmonary tuberculosis, renaltuberculosis, lymph node tuberculosis and bone tuberculosis; 6) Cardiovascular disease andhistory, various heart diseases, hypertension, hypotension, myocarditis andthrombophlebitis; 7) Respiratory diseases (including chronic bronchitis, emphysema,bronchiectasis and pulmonary insufficiency); 8) Digestive system diseases (e.g. severegastric and duodenal ulcers, chronic gastroenteritis and chronic pancreatitis); 9) Urinarysystem diseases (e.g. acute and chronic nephritis, chronic urinary system infection,nephrotic syndrome, acute and chronic renal insufficiency, etc.); 10) Various hematologicaldiseases (including anemia, leukemia, polycythemia vera and various hemorrhagic andcoagulative diseases); 11) Endocrine diseases or metabolic disorders (e.g. hyperthyroidism,acromegaly, diabetes insipidus, diabetes mellitus, etc.); 12) Organic nervous systemdiseases or psychoses (e.g. encephalitis, sequelae of brain trauma, epilepsy,schizophrenia, hysteria, severe neurasthenia, etc.); 13) Parasitic diseases and endemicdiseases (e.g. kala-azar, schistosomiasis, filariasis, hookworm disease, taeniasis,paragonimiasis, Keshan disease, Kaschin-Beck disease, etc.); 14) Malignancies and benigntumors affecting health; 15) History of haematological malignancies (e.g. leukaemia,lymphoma, myeloma), history of malignancies known to be associated with viraemic conditions (except for carcinoma in situ of the cervix). For other cancers, the donors should havefully recovered with no expectation of recurrence (i.e. cured) and the following conditionsapply:

1. for cancers with negligible metastatic potential (e.g. basal cell carcinoma andcarcinoma in situ of the cervix), the donors may be accepted immediately followingsuccessful removal and cure

2. for all other cancers, at least 5 years should have elapsed since completion of activetreatment 16) Undergone resection of stomach, kidney, gallbladder, spleen, lung andother important organs; 17) Exposure to harmful substances or radioactive substances (except for clinical radiology); 18) High-risk groups susceptible to HIV infection,such as drug users, homosexuals and people with multiple sexual partners; 19)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) andvCJD; 20) Chronic skin diseases, especially infectious, allergic and inflammatorysystemic skin diseases (e.g. favus, generalized eczema, systemic psoriasis, etc.); 21)Autoimmune diseases and collagenosis (e.g. systemic lupus erythematosus,dermatomyositis, scleroderma, etc.); 22) Bitten by animals carrying rabies virus; 23)Other diseases or conditions in which donors are ineligible to donate PBMC in theopinion of physicians; Donors should be deferred for the time being under the following circumstances:

3. Tooth extraction or other minor surgery within half a month;

4. 3 days before or after menstruation, menstrual disorders, pregnancy, less than 6months after abortion, less than 1 year after delivery and lactation;

5. Less than 1 week after the recovery of cold and acute gastroenteritis, less than 1month after the cure of acute urinary system infection, and less than half a yearafter the cure of pneumonia;

6. Donors from high-risk areas of infectious diseases as prescribed by certain infectiousdiseases and epidemic prevention departments. Less than half a year after the cure ofdysentery, less than 1 year after the cure of typhoid fever and brucellosis, historyof malaria within 3 years;

7. Within 2 years after blood transfusion treatment;

8. Less than 1 year after tattoo, injuries or contaminated wounds caused by equipmentcontaminated by blood or tissue fluid;

9. Close contact history with patients with infectious diseases: within the longestincubation period of the disease after the date of contact;

10. Recipients of animal serum products: within 4 weeks after the last injection;

11. Recipients of hepatitis B immunoglobulin (HBIG) injection: within 1 year; Provisions for PBMC collection after immunization:

1. Asymptomatic donors who have recently received immunization may donate PBMC only afterthe following period of time: 2 weeks after the last immunization of measles, mumps, yellowfever, poliomyelitis and live attenuated hepatitis A vaccine, 4 weeks after the lastimmunization of live rubella vaccine and rabies vaccine;