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

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

Study Overview

• Status: Unknown
• Conditions: Peripheral Blood Mononuclear Cell
• Intervention / Treatment: Other: Peripheral blood mononuclear cell apheresis

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The First Hospital of Zhejiang Medical Colleage Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy donor	Other: Peripheral blood mononuclear cell apheresis; Peripheral blood mononuclear cell collection for tumor immunotherapy study of UCAR-T cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the number of PBMC count	UCAR-T cell	1 years

Collaborators and Investigators

• Sponsor: He Huang
• Collaborators: Nanjing Bioheng Biotech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2020
• Primary Completion (Anticipated): July 18, 2020
• Study Completion (Anticipated): August 31, 2022

Study Registration Dates

• First Submitted: June 19, 2020
• First Submitted That Met QC Criteria: June 25, 2020
• First Posted (Actual): June 26, 2020

Study Record Updates

• Last Update Posted (Actual): June 26, 2020
• Last Update Submitted That Met QC Criteria: June 25, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: BHCT-TCELL-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No