Status:
UNKNOWN
Peripheral Blood Mononuclear Cell Collection Protocol for UCART Cell Tumor Immunotherapy Study
Lead Sponsor:
He Huang
Collaborating Sponsors:
Nanjing Bioheng Biotech Co., Ltd.
Conditions:
Peripheral Blood Mononuclear Cell
Eligibility:
All Genders
18-40 years
Phase:
NA
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
- 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
- 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;
Key Trial Info
Start Date :
June 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04448509
Start Date
June 18 2020
End Date
August 31 2022
Last Update
June 26 2020
Active Locations (1)
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1
The First Hospital of Zhejiang Medical Colleage Zhejiang University
Hangzhou, Zhejiang, China, 310000