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 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT03824951
Eligibility Criteria:
Inclusion Criteria:
1. CD19 (+) B cell lymphoma confirmed by pathological immunohistochemistry or flow cytometry
2. Previously accepted ≥ first-line regimen chemotherapy
3. Unconditional acceptance of hematopoietic stem cell transplantation or recurrence after hematopoietic stem cell transplantation
4. Over 18 years old and under 70 years old
5. The expected survival period is more than 3 months.
6. ECOG≤2
7. Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%, no abnormal electrocardiogram; blood oxygen saturation ≥90%; creatinine clearance ≥40 mL/min; ALT and AST≤3 times normal range, Total bilirubin ≤ 2.0 mg / dL;
8. Blood routine: Hgb≥80 g/L, ANC≥1×109/L, PLT≥50×109/L;
9. The pregnancy test for women of childbearing age must be negative; both men and women must agree to use effective contraception during the treatment period and for the following 1 year.
10. Measurable target lesion
Exclusion Criteria:
1. Patients with extramedullary relapse
2. Burkitt's lymphoma/leukemia
3. Previously received gene product treatment, anti-CD19/anti-CD3 treatment, or any anti-CD19 treatment;
4. Liver and kidney function:
* Total bilirubin \> 2 x ULN (Gilbert Syndrome \> 3 x ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 3 × ULN
* Serum creatinine clearance \>60 mL/min
5. Serological examination:
* Absolute neutrophil count (ANC) \<0.75x109/L
* Platelet count (PLT) \<50x109/L
6. Active hepatitis B (HBV-DNA \> 1000 copies / mL), hepatitis C, or uncontrolled infection
7. GVHD ≥ 2 or anti-GVHD treatment
8. IM19 CAR NK cells received allogeneic cell therapy within 6 weeks before infusion, such as donor lymphocyte infusion;
9. Subject received the most recent treatment (release, chemotherapy, or other) less than 4 weeks
10. Active CNS disease (tumor cells in CSF, but \< 5 WBCs/mL can be included);
11. Intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation
12. Creatinine \> 1.5 times normal upper limit or ALT / AST \> 3 times normal upper limit or bilirubin \> 2 times normal upper limit
13. New York Heart Association (NYHA) graded above or above
14. Uncontrollable diabetes
15. Suffering from other uncontrolled diseases, the researchers believe that it is not suitable for joining
16. Any situation that the investigator believes may increase the risk of the subject or interfere with the test results
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03824951
Study Brief:
Protocol Section:
NCT03824951