Donor-derived Anti-CD123-CART Cells for Recurred AML After Allo-HSCT

This is an interventional treatment trial for Adult Acute Myeloid Leukemia focused on measuring Leukemia, Leukemia, Myeloid, Recurrence, Neoplasms by Histologic Type, Disease Attributes, Cyclophosphamide, Fludarabine, CD123, Chimeric Antigen Receptor modified T-cells Read More

Inclusion Criteria:

1. Male and Female subjects with CD123+ acute myeloid leukemia as confirmed by immunohistochemistry and flow cytometry;
2. Patients must have received an allogenic stem cell transplantation(Allo-HSCT). The leukemia relapsed. There are available donor or enough cryopreserved donor-derived PBMCs for CART preparation and subsequent Allo-HSCT. In the previous case, the donor should have adequate venous access for apheresis.
3. Karnofsky score greater than 70%;
4. patients more than 18 years of age
5. Expected survival time >16 weeks;
6. Bilirubin <3.0 mg/dL,
7. Alanine aminotransferase(ALT)/ aspartate aminotransferase(AST)<3 fold normal.
8. Diffusing capacity of the lung for carbon monoxide(DLCO) and forced expiratory volume in one second(FEV1)>45% of predictive value.
9. At least received three kinds of medicines functioning by different mechanisms, including alkylating agents, protease inhibitors, and immunomodulators, and disease progressing within 60 days.
10. Important organs are well tolerated;
11. For post-transplantation patients, the apheresis would be undertaken only at least 2 weeks after immunosuppressive agents for GvHD withdrawal;
12. From very beginning of the test to 30 days after the withdrawal, men and women should adopt reliable contraceptive measures.
13. All research participants must have the ability to understand and willingness to sign a written informed consent.

Exclusion criteria:

1. Patients were diagnosed with APL M3:t(15; 17)(q22; q12);PML/RARα ）；
2. Symptomatic active central nervous system leukaemia;
3. Patients with HIV, hepatitis B or C infection;
4. Any concurrent active malignancies;
5. Other uncontrolled active illness that hinders participation in the trial;
6. Patients suffer from coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage and other serious heart, cerebrovascular disease;
7. patients with poorly controlled hypertensive
8. patients with froward psychiatric history
9. anyone who the researchers think unsuitable to participate in the investigation;
10. anyone who long-term use of immunosuppressive agents for organ transplants or other reasons, or undertake inhaled corticosteroids therapy recently.
11. failed production release testing: CAR+ T cells <30% or T cell expansion less than 5-fold under the CD3/28 beads stimulation.
12. Pregnant, lactating or female patients planning to get pregnant within 2 months before treatment ends;