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 @ 7:41 PM
Ignite Modification Date:
2025-12-24 @ 7:41 PM
NCT ID:
NCT03540303
Eligibility Criteria:
Inclusion Criteria:
* 18-70 years old and the expected lifetime \>3 months
* Refractory/relapsed CD19 positive B cell lymphoma by pathology
* ECOG score \<2
* Measureable lesions according to RECIST 1.1
* Sufficient heart, liver, kidney and bone marrow 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; bone marrow: WBC ≥ 2.0 × 109/L, Hb ≥ 80 g/L, PLT ≥ 30 × 109/L)
* no serious allergies
* No other serious diseases that conflict with this protocol (eg, autoimmune diseases, immunodeficiency, organ transplantation)
* No other history of malignancy
* No serious mental disorders
* 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:
* Lactating women
* Severe infectious or viral diseases (HIV positive, syphilis, etc.)
* Active hepatitis B or C viral hepatitis
* 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:
NCT03540303
Study Brief:
Protocol Section:
NCT03540303