Acute Myeloid Leukemia
Conditions
Interventions
Case series:Donor-derived anti-CD123-CART cells infusion
Sponsors
Tianjin First Central Hospital
Eligibility
Sex/Gender
All
Age
5 Years to 70 Years
Inclusion criteria
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 T cells for CART preparation; 3. ECOG Performance Status 0-2; 4. Aged 5-70 years old; 5. Expected survival time >3 months; 6. Bilirubin 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
Exclusion criteria: 1. Patients were diagnosed with APL M3:t (15; 17)(q22; q12);PML/RARa); 2. Symptomatic active central nervous system leukaemia; 3. Patients with HIV, hepatitis B or C infection; 4. Other uncontrolled active illness that hinders participation in the trial; 5. Any concurrent active malignancies; 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. Pregnant, lactating or female patients planning to get pregnant within 2 months before treatment ends.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate, safety and tolerance;six cytokines, procalcitonin and C-reactive protein, etc.;the changes in T cell subsets after treatment; | — |
Countries
China
Contacts
Public ContactMingfeng Zhao
Department of hematology, Tianjin First Central Hospital
Outcome results
None listed