Apheresis Collection for New Drug Development and Evaluation (PBMCs)
Official title: Apheresis Collection for New Drug Development and Evaluation Research
Run by TCRx Therapeutics Co.Ltd · NCT07663565 · Data updated 2026-11-12
This observational study will collect peripheral blood mononuclear cells (PBMCs) from about 200 adults aged 18–40 to create cell samples for research.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 40 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | TCRx Therapeutics Co.Ltd Industry-sponsored |
| Locations | 2 sites (Bengbu, Anhui and 1 other locations) |
| Status | Recruiting |
| Started | June 22, 2026 |
| Main results expected | June 21, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | October 26, 2026 |
| Trial ID | NCT07663565 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–40 years old, both male and non-pregnant female, with adequate weight and BMI and no clinically significant organ disease or infection.
✕Probably not a fit
Participants should not expect direct medical benefit from the cell collection itself.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this study, researchers will obtain PBMCs from eligible participants through apheresis, aiming for roughly 8×10^9 mononuclear cells per subject from about 150 mL of blood. The trial is conducted at two hospitals in Anhui, China, with no interventions beyond sample collection. Subjects will be screened for generally healthy status, and standard blood values are allowed to be outside typical ranges if not clinically significant. The study focuses on collecting cells as a resource for developing and evaluating a new drug, rather than testing a therapeutic intervention in participants.
Why it matters
Potential benefit: Participants may contribute to the development of new therapies by providing valuable PBMC samples.
How similar studies have gone: Other studies have used PBMC collection via apheresis to support drug development and immunology research, with varying apheresis yields.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged between 18 and 40 (inclusive), male or non-pregnant female, regardless of nationality. Weight: Male ≥ 50kg; Female ≥ 45kg, and 19kg/m2 ≤ BMI ≤ 30kg/m2 (BMI, Body Mass Index = weight (kg) ÷ height (m)2). Blood pressure: Measurement results are either normal or abnormal, but without clinical significance. Pulse rate: Measurement of normal or abnormal pulse rate has no clinical significance. Temperature (ear temperature): 35.4-37.2℃. The patient's general condition is good: there is no damage to vital organs such as the heart, lungs, liver, and kidneys, no severe or uncontrolled infections, and no history of severe mental disorders. Clinical examination must meet the following criteria: • Hemoglobin (Hb) measurement is normal or abnormal without clinical significance • White blood cell count (WBC) measurement is normal or abnormal without clinical significance • Platelet count (PLT) measurement is normal or abnormal without clinical significance • Neutrophil count (NEU) measurement is normal or abnormal without clinical significance • Liver function test indicators \<1.5ULN • Coagulation function is normal or abnormal without clinical significance • 12-lead electrocardiogram results are normal or abnormal without clinical significance • Hepatitis A virus antibody (HAV) is negative. Hepatitis B virus surface antigen (HBsAg) negative Hepatitis C virus antibody (HCV antibody) negative. Human immunodeficiency virus antibody (HIV-1 and HIV-2 antibody) negative. Treponema pallidum antibody test is negative. The test result for CMV IgM antibody is negative. Exclusion Criteria: * Previously had adverse reactions to blood donation. The following diseases are considered clinically significant by researchers: autoimmune diseases, severe endocrine and metabolic diseases, malignant tumors, neuropsychiatric diseases; Creutzfeldt-Jakob disease and those with a family history, or those who have received treatment with tissues or tissue derivatives that may have been infected with the Creutzfeldt-Jakob pathogen; chronic skin diseases, especially infectious, allergic, or inflammatory systemic skin diseases; those with allergic diseases or recurrent allergies; those who have undergone surgical operations in the past three months. Women who are in their menstrual period, pregnancy, less than 6 months after abortion, or less than 1 year since the end of childbirth and lactation period. Individuals who have recovered from an upper respiratory infection within the past week, or those who have recovered from pneumonia within the past three months. Individuals with urinary system infections less than 3 months old, or those experiencing an acute episode of urinary system stones. Equipment contaminated by blood or tissue fluid causing injury or contaminating wounds, or individuals who have undergone tattooing less than one year ago. Long-term uninterrupted use of hormone drugs or immunosuppressants exceeding physiological replacement doses is required, including but not limited to glucocorticoids and steroids, hydroxyurea, and immunomodulatory drugs (such as alpha or gamma interferon, GM-CSF, mTOR inhibitors, cyclosporine, thymosin, etc.) in doses exceeding physiological replacement levels. Those who have received whole blood and blood component transfusions within 1 year. Those who have received their last dose of antitoxin or immune serum within 1 year, or those who have received their last dose of hepatitis B immunoglobulin injection within 1 year. Individuals who have received the last dose of live attenuated vaccines such as measles, mumps, or polio vaccines within 2 weeks, or the last dose of live rubella vaccines or live attenuated Japanese encephalitis vaccines within 4 weeks. Individuals who have received the final immunization dose of rabies vaccine within one year after being bitten by an animal. Poor conditions for vascular puncture, unable to tolerate venipuncture, or history of fainting at the sight or touch of blood. Upon inquiry, individuals with a history of drug use, drug abuse, or positive drug abuse screening (morphine, methamphetamine, ketamine, tetrahydrocannabinolic acid, MDMA) within the previous 12 months prior to screening. Healthy volunteers who have participated in intervention drug clinical studies and have used study drugs within 7 days prior to screening. Other situations where the researcher believes participation in this study is not appropriate.
Where it's running
-
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China Recruiting -
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China Suspended
Study contacts
- Study coordinator: JingChao Liu
- Email: liujc@tcrximmune.cn
- Phone: +86 18115621929
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.