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

NCT ID: NCT04448509

Last Updated: 2020-06-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-18
• Study Completion Date: 2022-08-31

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

Conditions

Peripheral Blood Mononuclear Cell

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Healthy donor

Healthy donor

Group Type: OTHER

Peripheral blood mononuclear cell apheresis

Intervention Type: OTHER

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

Interventions

Peripheral blood mononuclear cell apheresis

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

Intervention Type: OTHER

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nanjing Bioheng Biotech Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

He Huang

OTHER

Sponsor Role: lead

Responsible Party

He Huang

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The First Hospital of Zhejiang Medical Colleage Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

He Huang, PhD

Role: CONTACT

huanghe@zju.edu.cn

86-13605714822 ext. 86-13605714822

Jimin Shi, MD

Role: CONTACT

jiminshi@126.com

86-13857119907 ext. 86-13857119907

Facility Contacts

He Huang, PhD

Role: primary

huanghe@zju.edu.cn

86-13605714822

Other Identifiers

BHCT-TCELL-04

Identifier Type: -

Identifier Source: org_study_id