Collection of PBMCs From Healthy Subjects for the Development of Cellular Immunotherapy Product

NCT04295096 | Unknown

• 1 other identifier: BM2L201909
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

Title: Collection of Peripheral Blood Mononuclear Cells (PBMCs) From Healthy Subjects for the Development of Cellular Immunotherapy Product Background: CAR-T therapies are being developed that utilize modified immune cells to fight tumors. 'Off-the-shelf' allogeneic CAR-T technology has better efficacy and more promising clinical applications. Investigators want to use the cells of healthy subjects to perform the studies. To accomplish this, they are collecting PBMCs through apheresis. Objectives: To collect PBMCs from healthy subjects for product development for cell Immunotherapies.

Conditions

Healthy Subject

Outcome Measures

Primary Outcomes (1)

• Collect blood samples

  Collect blood samples (whole blood and PBMC) from healthy subjects for the Development of Cellular Immunotherapy Product.

  2 years

Study Arms (1)

Experimental

OTHER

Healthy donor

Device: Peripheral blood mononuclear cell apheresis

Interventions

Peripheral blood mononuclear cell apheresis DEVICE

Peripheral blood mono-nuclear cell donation for tumor immunotherapy study of Universal CAR-T cells

Experimental

Eligibility Criteria

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

You may qualify if:

• to 40 years of age
• Male≥50 kg, female≥45 kg with 18.5≤ BMI ≤30
• Subject has provided informed consent

You may not qualify if:

• Subject has respiratory diseases, circulatory system diseases, digestive system diseases, urinary system diseases, hematological system diseases, autoimmune diseases, endocrine disorders or metabolic disorders;
• Subject has nervous system diseases, mental illness, Creutzfeldt-Jakob disease or those with a family history, or those treated with tissue or tissue derivatives that may be derived from Creutzfeldt-Jakob infected people;
• Subject has chronic skin diseases, especially infectious, allergic or inflammatory systemic skin diseases;
• Subject has allergic diseases or recurrent allergies;
• Malignant tumors or health-affecting benign tumors;
• Twice or more times of blood pressure measurement exhibit (except for white coat hypertension): systolic blood pressure \< 90 or ≥ 140 Millimeter of mercury (mm Hg), or diastolic blood pressure \< 60 or ≥ 90 mm Hg, or pulse pressure \< 30 mm Hg, heart rate: \< 60 beats/min or \>100 beats/min;
• Laboratory tests: hemoglobin: male \<120 g/L, female \<115 g/L, or liver and kidney laboratory result \>1.5x upper limit of normal with clinical significant, or abnormal12-lead ECG with clinical significant, or abnormal abdominal B-mode ultrasound with clinical significant, or abnormal chest X-ray with clinical significant, and T cell detection of tuberculosis infection is over the limit or positive;
• Abnormal lymphocyte subset panel test result with clinical significance (Lymphs%, CD3+, CD3+CD4+, CD3+CD8+, CD3-CD16+CD56+,CD19+) ;
• Hepatitis B surface antigen positive, hepatitis B virus (HBV) DNA positive, hepatitis B e antigen positive, hepatitis C antibody positive, Treponema pallidum antibody positive ,human immunodeficiency virus antibody positive, human T-cell lymphotrophic virus antibody positive, Epstein-Barr virus positive, or COVID-19 nucleic acid positive ;
• Recipient of organ transplant;
• Received any major organ resection such as stomach, kidney, spleen and lung;
• Subject has transfusion-associated infectious diseases;
• Minor surgery within 3 months, such as appendectomy and recovered ophthalmic surgery; Major surgery within l 1 year, such as surgical treatment for gynecological benign tumors or superficial benign tumors;
• Pregnant, or have an abortion within l 6 months, childbirth within 1 year;
• Upper respiratory infection recovered within 1 week, or pneumonia recovered within 3 months;

Sponsors & Collaborators

• Jun Zhu: lead
• Nanjing Legend Biotech Co.: collaborator

Study Sites (1)

Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai

Shanghai, China

RECRUITING

Study Officials

• Jun Zhu, M.D.

  Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Zhu, M.D.

CONTACT

+86-021-36561999; zhuj@bohuhealthcare.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: Chief Physician

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 4, 2020
• Study Start: April 1, 2020
• Primary Completion: February 1, 2024
• Study Completion: March 1, 2024
• Last Updated: June 9, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)