Clinical trial NCT04448509: Peripheral Blood Mononuclear Cell Collection Protocol for UCART Cell Tumor Immunotherapy Study
Official title: Peripheral Blood Mononuclear Cell Collection Protocol for UCART Cell Tumor Immunotherapy Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Blood Mononuclear Cell
Lead sponsor: Zhejiang University
Sponsor class: OTHER
Collaborators: name: Nanjing Bioheng Biotech Co., Ltd.
First posted: 2020-06-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

Eligibility criteria: 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;

Primary outcomes:
measure: the number of PBMC count
timeFrame: 1 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Hospital of Zhejiang Medical Colleage Zhejiang University
state: Zhejiang
Study officials:
References: