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 @ 4:01 AM
Ignite Modification Date:
2025-12-25 @ 4:01 AM
NCT ID:
NCT04163302
Eligibility Criteria:
Inclusion Criteria:
1. Male or female, aged 14 to 80 years (including 14 and 80 years old).
2. The diagnosis was Refractory/relapsed B-cell lymphoma.(Meeting 1 of the first 4 items plus item 5)
A.Tumor shrinkage less than 50% or disease progression after 4 cycles of standard chemotherapy.
B.Achieved CR after standard chemotherapy, but relapsed within 6 months.
C.2 or more relapses after CR.
D.Not suitable for HSCT, or relapse after HSCT.
E.Subjects must have received adequate treatment in the past and the predicted survival is more than three months.
3. Patient or his or her legal guardian voluntarily participates in this stuy and signs an informed consent form.
4. Flow cytometry or immunohistochemistry showed CD19 positive in tumor cells.
5. No serious concomitant disease and major organ function is not serious abnormal.
6. ECOG physical condition score 0-3 or KPS score \> 80.
7. the test meets the following indicators:
A.ALT/AST \< 2.5 times the upper limit of normal (ULN) and total bilirubin≤34.2μmol/L.
B.Creatinine \< 176.8 μmol/L.
C.WBC≥2.5×109/L ，LY≥0.7×109/L，LY%≥15%.
D.PT/INR \< 1.7 or PT was extended by less than 4 seconds.
Exclusion Criteria:
1. Women who are pregnant or breastfeeding.
2. Patients whose tumor cell don't have positive CD19 antigen.
3. Active hepatitis B or hepatitis C, HIV/AIDS infection, any uncontrolled active infection.
4. Patients who are using steroid drugs throughout the body currently.
5. Patients who have received any gene therapy in the past.
6. Patients who are allergy to immunotherapy and related drugs.
7. Patients with heavy heart disease or poorly controlled high blood pressure.
8. Patients who received chemotherapy or radiation 4 weeks before the study began.
9. Patients who are participating in other clinical trials.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
80 Years
Study:
NCT04163302
Study Brief:
Protocol Section:
NCT04163302