Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-25 @ 4:33 AM
NCT ID:
NCT06040918
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years old.
* Healthy donors must be free of acute or chronic medical conditions (e.g., hypertension, kidney disease, diabetes, autoimmune disease, cardiovascular disease).
* Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
* Adequate organ function, evidenced by the following laboratory results:
Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 Platelet count ≥ 100,000 cells/mm3 Hemoglobin ≥ 9.0 g/dL Total bilirubin ≤ 1.5 x upper limit of normal (ULN); unless the subject has documented Gilbert's syndrome Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 3 x ULN Serum creatinine ≤ 2.0 mg/dL or 177 μmol/L
* Adequate peripheral venous access.
* Must be able to be in the clinic for up to 6 hours on the day of collection.
* Must be able to sit or recline with limited movement for approximately 2-3 hours.
* Must agree to provide blood samples for clinical testing and immunological analysis.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0.
Exclusion Criteria:
* Received systemic antibiotics within 14 days prior to apheresis collection.
* New York Heart Association (NYHA) functional assessment score of \> Class I.
* Any medical diagnosis that would prevent the donation of WBCs.
* History of or active human immunodeficiency virus (HIV).
* Active hepatitis B or hepatitis C.
* Have been advised by a medical provider not to donate blood.
* Women who are pregnant or breastfeeding. A negative serum pregnancy test in women of child-bearing potential is required at screening.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06040918
Study Brief:
Protocol Section:
NCT06040918