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:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
NCT ID:
NCT07137312
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed current or previous solid malignancy or healthy individuals
* Willing to provide mandatory research blood draw or apheresis per protocol
* Provide written informed consent
* The following laboratory values obtained ≤ 28 days prior to registration
* Hemoglobin ≥10.0 g/dl
* Absolute neutrophil count (ANC) ≥1500/mm\^3
* Platelet count ≥100,000/mm\^3
Exclusion Criteria:
* Any of the following prior therapies:
* IV antibiotic ≤2 weeks prior to apheresis
* Major Surgery ≤4 weeks prior to registration
* Received a live vaccine ≤30 days prior to registration
* Active hematologic malignancies ≤ 3 years prior to registration
* Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy
* History of active tuberculosis (TB), human immunodeficiency virus (HIV), active hepatitis B (e.g., HBsAg reactive), and/or active hepatitis C infection \[e.g., Hepatitis C Virus (HCV) ribonucleic acid (RNA) qualitative is detected)
* Known history of active autoimmune disease that has required systemic treatment in the ≤14 days (i.e., with the use of disease-modifying agents, corticosteroids \>10 mg daily prednisone equivalent, or other immunosuppressive drugs) prior to registration.
* NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded.
* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
* Pregnancy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07137312
Study Brief:
Protocol Section:
NCT07137312