Status:
UNKNOWN
Collection of PBMCs From Healthy Subjects for the Development of Cellular Immunotherapy Product
Lead Sponsor:
Jun Zhu
Collaborating Sponsors:
Nanjing Legend Biotech Co.
Conditions:
Healthy Subject
Eligibility:
All Genders
18-40 years
Phase:
NA
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 utili...
Detailed Description
Background: Autologous chimeric antigen receptor (CAR) T cells have changed the therapeutic landscape in haematological malignancies. Nevertheless, the use of allogeneic CAR T cells from donors has m...
Eligibility Criteria
Inclusion
- 18 to 40 years of age
- Male≥50 kg, female≥45 kg with 18.5≤ BMI ≤30
- Subject has provided informed consent
Exclusion
- 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;
- Acute pyelonephritis-recovered within 3 months, or urinary calculi onset;
- Injured or wound-contaminated by equipment contaminated by blood or tissue fluids, or has a tattoo within 1 year;
- Received whole blood and blood component transfusion within 1 year;
- Received the last vaccination of live attenuated vaccines such as measles, mumps, or polio within 2 weeks, or the last vaccination of rubella live vaccine, human rabies vaccine, live attenuated Japanese encephalitis vaccine within 4 weeks;
- Received the last vaccination of rabies vaccines after being bitten by an animal within 1 year;
- Received the last vaccination of antitoxin or immune serum injection within 4 weeks, or those who received the last vaccination of hepatitis B human immunoglobulin injection within 1 year;
- Participated in a clinical trials within 1 month; it should be discussed case by base if investigational product used.
- Those who are considered by the investigator as unsuitable for participating in the study.
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT04295096
Start Date
April 1 2020
End Date
March 1 2024
Last Update
June 9 2021
Active Locations (1)
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1
Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai
Shanghai, China