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 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT03146533
Eligibility Criteria:
Inclusion Criteria:
* 1\. 18 years to 70 years, expected survival \> 3 months;
* 2\. CD19 positive B-cell lymphoma;
* 3\. KPS \>80;
* 4\. Having at least one measurable lesions;
* 5\. Cardiac function: 1-2 levels; Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN; kidney: Cr≤1.25ULN; bone marrow: WBC ≥ 3.0×109/L, Hb ≥90 g/L, PLT ≥ 80×109/L）;
* 6\. No serious allergic constitution;
* 7\. No other serous diseases that conflicts with the clinical program;
* 8\. No other cancer history;
* 9\. No serious mental disorder;
* 10\. Informed consent is signed by a subject or his lineal relation.
Exclusion Criteria:
* 1\. Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test);
* 2\. Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
* 3\. Active hepatitis B or hepatitis C infection;
* 4\. Recent or current use of glucocorticoid or other immunosuppressor;
* 5\. With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
* 6\. Transaminase \>2.5ULN, Bilirubin \>3ULN，Creatinine\>1.25ULN
* 7\. Participate in other clinical research in the past three months; previously treatment with any gene therapy products;
* 8\. Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03146533
Study Brief:
Protocol Section:
NCT03146533