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:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2025-12-24 @ 11:51 AM
NCT ID:
NCT03664661
Eligibility Criteria:
Inclusion Criteria:
* 18 and ≤70 years old and the expected lifetime \>3 months
* Active myeloma according to IMWG criteria, and BCMA positive by immunohistochemistry or flow cytometry
* No effective treatment option available
* ECOG score 0-2
* Sufficient heart, liver, kidney function (heart: no heart disease or coronary heart disease, patient heart function NYHA grade 1-2; liver: TBIL ≤ 3ULN, AST ≤ 2.5ULN, ALT ≤ 2.5ULN; kidney: Cr≤ 1.25ULN);
* smoothly peripheral superficial veins
* No other serious diseases that conflict with this protocol (eg, autoimmune diseases, immunodeficiency, organ transplantation)
* No history of other malignancies
* Women of childbearing age must be negative for blood pregnancy test within 7 days and must take appropriated contraceptive measures during and 3 months after the study
* The patient himself agrees to participate in this clinical study and signed the "informed consent"
Exclusion Criteria:
* Severe infectious 4 weeks before enrollment
* Active hepatitis B or C viral hepatitis, HIV,
* Severe autoimmune disease or immunodeficiency disease
* Severe allergies
* Severe mental disorder
* Patients who used high-dose glucocorticoids within 1 week
* Participation in other clinical studies in the past 3 months or having been treated with other gene products
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03664661
Study Brief:
Protocol Section:
NCT03664661