A Study on the Collection of Peripheral Blood Mononuclear Cells From Healthy Volunteers for UCAR T Production and Clinical Investigation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Blood Mononuclear Cell
- Sponsor
- The First Affiliated Hospital of Soochow University
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- The number of peripheral blood mononuclear cells (PBMC
- Last Updated
- 4 years ago
Overview
Brief Summary
The objective of the study is to collect peripheral blood mononuclear cells (PBMC) from healthy volunteers for the research and production of UCAR T cells used for Clinical trails.
Detailed Description
The study is a single-center study. 1. Screening period: All volunteers are required to sign a written informed consent form for the study; after the signing of informed consent form, the demographic data and medical history of the volunteers will be collected, and physical examinations and local laboratory tests will be performed to assess the eligibility of the volunteers. Volunteers who meet all the inclusion criteria and do not meet any exclusion criteria will receive peripheral venous whole blood sampling, and the volunteers receiving apheresis based on the assessment results will be enrolled. 2. Apheresis period: 25 volunteers who meet the inclusion criteria will undergo collection of peripheral blood mononuclear cells (PBMC) by means of apheresis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy volunteers who signed informed consent form
- •Age ≥ 18 years and ≤ 40 years, male or female, Han nationality.
- •Weight: male ≥ 50 kg, female ≥ 45 kg; 18.5 ≤ BMI ≤
- •Temperature: 36.3-37.2℃ (Forehead temperature).
Exclusion Criteria
- •Those with known respiratory, circulatory, digestive, urinary, blood, immune, endocrine disorders or metabolic disorders, neurological diseases, mental illnesses and those with a family history;
- •Those with known chronic skin diseases, especially infectious, allergic or inflammatory systemic skin diseases;
- •Those with known allergic diseases or recurrent allergies;
- •Those with known malignant tumors or health-affecting benign tumors;
- •Two or more physical examination results of blood pressure have shown (except for white coat hypertension): systolic blood pressure \< 90 or ≥140mmHg, or diastolic blood pressure \< 60 or ≥ 90 mmHg, or pulse pressure \< 30 mmHg, heart rate: \< 60 beats/min or \>100 beats/min;
- •Laboratory tests: hemoglobin is abnormal and has clinical significant; liver and kidney function are higher than the normal upper limit and have clinical significance; 12-lead ECG is abnormal and has clinical significance, or abdominal ultrasound is abnormal and has clinical significance, or chest X-ray is abnormal and has clinical significance; abnormal coagulation function; increased CRP;
- •Those with active or latent hepatitis B or active hepatitis C, or Treponema pallidum antibody, or human immunodeficiency virus antibody, or anti-EBV IgM antibody, or anti-CMV IgM antibody, or COVID-19 DNA ;
- •Recipients of allogeneic tissue and organ or hematopoietic stem cell transplants;
- •Those who have undergone resection of vital internal organs such as stomach, kidney, spleen and lung;
- •Those who have undergone minor surgery within last 3 months, such as appendectomy and ophthalmic surgery; those who have undergone major surgery within 1 year, such as surgical treatment for gynecological benign tumors or superficial benign tumors;
Outcomes
Primary Outcomes
The number of peripheral blood mononuclear cells (PBMC
Time Frame: 2 year