Peripheral Blood Mononuclear Cell Collection Protocol for UCART Cell Tumor Immunotherapy Study

Peripheral Blood Mononuclear Cell Clinical Trial

Official title:

Peripheral Blood Mononuclear Cell Collection Protocol for UCART Cell Tumor Immunotherapy Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04448509
• Other study ID #: BHCT-TCELL-04
• Status: Recruiting
• Phase: N/A
• Start date: June 18, 2020
• Est. completion date: August 31, 2022

Study information

• Verified date: June 2020
• Source: Zhejiang University
• Contact: He Huang, PhD
• Phone: 86-13605714822
• Email: huanghe[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Peripheral blood mononuclear cell collection protocol for tumor immunotherapy study of UCAR-T cells

Description:

Collect blood samples (whole blood and PBMC) from healthy donors for the development and production of UCAR-T cells

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 31, 2022
• Est. primary completion date: July 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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;

Related Conditions & MeSH terms

• Peripheral Blood Mononuclear Cell

Intervention

Other:
• Peripheral blood mononuclear cell apheresis
Peripheral blood mononuclear cell collection for tumor immunotherapy study of UCAR-T cells

Locations

Country	Name	City	State
China	The First Hospital of Zhejiang Medical Colleage Zhejiang University	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
He Huang	Nanjing Bioheng Biotech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the number of PBMC count	UCAR-T cell	1 years