CD123-Targeted CAR-T Cell Therapy for Relapsed/Refractory Acute Myeloid Leukemia

This is an interventional treatment trial for Leukemia Read More

Inclusion Criteria:

1. Signed written informed consent；

2. Diagnose as Relapsed/Refractory AML, and meet one of the following conditions：

   1. With persistent disease after at least two lines of therapy；
   2. Relapse to the last line of therapy in 6 months，as known as early recurrence;
   3. Relapse to the last line of therapy after 6 months, but refractory to this last line of therapy；
   4. Relapse more than once. The definition of relapse: Reappearance of blasts in the blood or bone marrow (>5%) or in any extramedullary site after a CR (the most common are CNS and testicular leukemia).
3. Evidence for cell membrane CD123 expression;
4. KPS>60;
5. The expect time of survive is above 3 months;
6. Ages: 2 to 75 years;
7. All genders;
8. The patients that diagnosis as high risks, relapse/refractory or inconformity criteria to other therapy；
9. No serious mental disorders;
10. Left ventricular ejection fraction ≥40%;
11. Sufficient hepatic function defined by ALT/AST<5 x ULN and bilirubin≤34.2μmol/L;
12. Sufficient renal function defined by creatinine clearance <220μmol/L;
13. Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
14. No other illness may conflict with the protocol (e.g. autoimmune diseases, immune deficiency and organ transplantation；
15. Ability and willingness to adhere to the study visit schedule and all protocol requirements.

Exclusion Criteria:

1. Previous history of other malignancy;
2. Presence of uncontrolled active infection;
3. Evidence of disorder that need the treatment by glucocorticoids;
4. Active or chronic GVHD；
5. The patients treatment by inhibitor of T cell；
6. Pregnant or breasting-feeding women;
7. Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.