Relapsed/Refractory Acute Myeloid Leukemia
Conditions
Interventions
Sponsors
Zhongshan People's Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged from 18 to 70 years (including the cut-off value) were not limited in gender; 2. Patients whose expected survival time is not less than 2 months; 3. Patients with ECoG score 0-2; 4. Patients with positive CD33 expression and one of the following conditions: (1) The patients with true acute myeloid leukemia (except m3) were treated with standard chemotherapy (2) It includes relapse after hematopoietic stem cell transplantation, which is not affected by other previous treatments. 5. Patients whose liver and kidney function and cardiopulmonary function meet the following requirements: (1) Creatinine was in the normal range; (2) Left ventricular ejection fraction > 50%; (3) Baseline oxygen saturation > 92%; (4) Total bilirubin <= 2 times the upper limit of normal value; ALT and AST <= 2.5 times the upper limit of normal value; 6. Patients who understand the trial and have signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with graft-versus-host disease (GVHD) or those who need immunosuppressants; 2. In the first 5 years of screening, patients with malignant tumors other than acute myeloid leukemia, in addition to cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical operation, and ductal carcinoma in situ after radical operation, were fully treated; 3. Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and HBV DNA titer in peripheral blood >= 3 x 10^2 copies / L; subjects with positive hepatitis C virus (HCV) antibody and HCV RNA in peripheral blood; subjects with positive human immunodeficiency virus (HIV); subjects with positive CMV DNA; subjects with positive syphilis; subjects with positive hepatitis C virus (HCV) antibody and HCV RNA in peripheral blood; 4. Patients with any unstable systemic diseases: including but not limited to unstable angina pectoris, cerebrovascular accident or transient cerebral ischemia (within 6 months before screening), myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification >= III), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases; 5. Patients with active infection or uncontrollable infection requiring systemic treatment within 14 days before enrollment; 6. Pregnant or lactating women, female subjects who plan to conceive within one year after cell transfusion or male subjects whose partners plan to conceive within one year after cell transfusion; 7. Patients with central nervous system involvement; 8. Other researchers think that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity; | — |
Countries
China
Contacts
Public ContactWeijia Wang
Zhongshan People's Hospital
Outcome results
None listed