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

NCT04448509 | Unknown DMC

• 1 other identifier: BHCT-TCELL-04
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peripheral Blood Mononuclear Cell

Outcome Measures

Primary Outcomes (1)

• the number of PBMC count

  UCAR-T cell

  1 years

Study Arms (1)

Healthy donor

OTHER

Healthy donor

Other: Peripheral blood mononuclear cell apheresis

Interventions

Peripheral blood mononuclear cell apheresis OTHER

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

Healthy donor

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• He Huang: lead
• Nanjing Bioheng Biotech Co., Ltd.: collaborator

Study Sites (1)

The First Hospital of Zhejiang Medical Colleage Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

Central Study Contacts

He Huang, PhD

CONTACT

86-13605714822; huanghe@zju.edu.cn

Jimin Shi, MD

CONTACT

86-13857119907; jiminshi@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 26, 2020
• Study Start: June 18, 2020
• Primary Completion: July 18, 2020
• Study Completion: August 31, 2022
• Last Updated: June 26, 2020

Record last verified: 2020-06

Locations

CN (1)