Collection of Peripheral Blood Mononuclear Cells by Means of Apheresis Clinical Trial
Official title:
A Study on the Collection of Peripheral Blood Mononuclear Cells From Healthy Volunteers for the Development of Allogeneic Cellular Immunotherapy Products
| Verified date | December 2021 |
| Source | The First Affiliated Hospital with Nanjing Medical University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The objective of the study is to collect peripheral blood mononuclear cells (PBMC) from healthy volunteers for the research and development of allogeneic cellular immunotherapy products.
| Status | Terminated |
| Enrollment | 4 |
| Est. completion date | December 9, 2021 |
| Est. primary completion date | December 9, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 40 Years |
| Eligibility | Inclusion Criteria: 1. Age = 18 years and = 40 years, male or female; 2. Weight: male = 50 kg, female = 45 kg; 18.5 = BMI = 30; 3. Healthy volunteers who signed informed consent form. Exclusion Criteria: 1. Those with known respiratory, circulatory, digestive, urinary, blood, immune, endocrine disorders or metabolic disorders; 2. Those with known neurological diseases, mental illnesses, Creutzfeldt-Jakob disease and those with a family history, or those treated with tissue or tissue derivatives that may be derived from Creutzfeldt-Jakob infected people; 3. Those with known chronic skin diseases, especially infectious, allergic or inflammatory systemic skin diseases; 4. Those with known allergic diseases or recurrent allergies; 5. Those with known malignant tumors or health-affecting benign tumors; 6. 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 difference < 30 mmHg, heart rate: < 60 beats/min or >100 beats/min; 7. Laboratory tests: hemoglobin determination: male <120 g/L, female <115 g/L, or liver and kidney function is more than 1.5 times the upper limit of normal and clinically significant, or 12-lead ECG is abnormal and clinically significant, or abdominal B-mode ultrasound is abnormal and clinically significant, or chest X-ray is abnormal and clinically significant, and T cell detection of tuberculosis infection is over the limit or positive; 8. lymphocyte subsets (lymphocyte proportion?CD3+?CD3+CD4+?CD3+CD8+?CD3-CD16+CD56+?CD19+)Abnormal detection and clinical significance; 9. Those with positive hepatitis B surface antigen or HBV DNA, or hepatitis B e antigen, or hepatitis C antibody, or Treponema pallidum antibody, or human immunodeficiency virus antibody; 10. Recipients of allogeneic tissue and organ transplants; 11. Those who have undergone resection of vital internal organs such as stomach, kidney, spleen and lung; 12. Those who have suffered from blood transfusion-associated infectious diseases; 13. Those who have undergone minor surgery within less than 3 months, such as appendectomy and ophthalmic surgery; those who have undergone major surgery within less than 1 year, such as surgical treatment for gynecological benign tumors or superficial benign tumors; 14. Women who are pregnant, or have an abortion within less than 6 months or have undergone less than 1 year after childbirth and lactation; 15. Those whose upper respiratory tract infection has recovered for less than 1 week, or pneumonia has recovered for less than 3 months; 16. Those whose acute pyelonephritis has recovered for less than 3 months, or those with acute exacerbation of urinary calculi; 17. Those who have been injured or wound-contaminated by equipment contaminated by blood or tissue fluids, or who have got a tattoo for less than 1 year; 18. Those who have received whole blood and blood component transfusion within 1 year; 19. Those who have received the last vaccination of live attenuated vaccines such as measles, mumps, or polio within 2 weeks, or have received the last vaccination of rubella live vaccine, human rabies vaccine, live attenuated Japanese encephalitis vaccine within 4 weeks; 20. Those who have received the last vaccination of rabies vaccines after being bitten by an animal within 1 year; 21. Those who have received the last vaccination of antitoxin or immune serum injection within 4 weeks, or those who have received the last vaccination of hepatitis B human immunoglobulin injection within 1 year; 22. Those who have participated in clinical trials within 1 month; if they have used investigational drugs, they need to be discussed case by case; 23. Those who cannot meet the basic biological indicators for UCAR-T product preparation, specifically including positive blood safety indicator sterility test result, or positive mycoplasma test result, or culture product endotoxin test = 10 EU/mL; basic biological indicator cell viability is < 70%, or the number of effective T lymphocytes cannot meet the needs of in vitro assessment, or the in vitro proliferative production characteristics of each component cell, or the proportion of each component cannot meet the UCAR-T preparation conditions; 24. Those who are considered by the investigator as unsuitable for participating in the study. |
| Country | Name | City | State |
|---|---|---|---|
| China | Hematological Department, People's Hospital of Jiangsu Province | Nanjing | Jiangsu |
| Lead Sponsor | Collaborator |
|---|---|
| The First Affiliated Hospital with Nanjing Medical University | Nanjing Legend Biotechnology Co.,Ltd. |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | the number of PBMC | two year |