relapsed or refractory acute myeloid leukemia
Conditions
Interventions
None:Transfuse the CAR-T cells
Sponsors
The First Affiliated Hospital of Medical College of Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent voluntarily and expect to complete the follow-up inspection and treatment of the research procedure; 2. Age: 18-70 years old (including the threshold), regardless of gender; 3. It conforms to the diagnosis of AML classified by WHO in 2016 and the diagnostic criteria of relapse and refractory acute myeloid leukemia in the Chinese Guidelines for the Diagnosis and Treatment of Relapsing and Refractory Acute Myeloid Leukemia (2017 Edition), and there is no clinically relevant treatment and registered clinical trial suitable at present: 1) Diagnostic criteria for recurrent AML: leukemic cells reappear in peripheral blood after complete remission (CR), or myeloblasts in bone marrow>0.050 (except for bone marrow regeneration after consolidation chemotherapy and other reasons), or leukemic cell infiltration appears outside the marrow; 2) Diagnostic criteria for refractory AML: primary cases that have not been effective after 2 courses of treatment with standard scheme; After CR, the patients were treated with consolidation and intensification, and recurred within 12 months; Recurrence after 12 months but ineffective after routine chemotherapy; 2 or more relapses; Extramedullary leukemia persists. 3) AML Blast flow cytometry confirmed the expression of CLL1/CLL1+CD33/CD123; 4) The patient has recovered from the toxicity of previous treatment, that is, the CTCAE toxicity grade is less than 2 (unless the abnormality is related to tumor); 4. The ECOG physical state score is 0-1 and the expected survival period is more than 3 months; 5. Have appropriate organ functions: A. AST = 60 mL/min; E Hemoglobin >= 60g/L or maintain this level after blood transfusion; F Indoor oxygen saturation >= 92%; G Left ventricular ejection fraction (LVEF) >= 45%; 6. Female subjects should also meet the following criteria before they can be considered: A Non-fertility is defined as: B has undergone hysterectomy or bilateral oophorectomy, or C has undergone bilateral tubal ligation, or D menopause (complete menopause >= 1 year); E Having fertility, but the serum pregnancy test was negative during screening, and agreed to be conducted before and during the study Take medically approved contraceptive measures (such as intrauterine devices, contraceptives or condoms) until the last study Within 1 year after treatment; 7. Male patients with active sexual ability must agree to take barrier contraception or complete abstinence; 8. The venous access required for collection can be established, and there is no contraindication for leukocyte collection; 9. Be willing and able to follow the taboos and restrictions specified in this program.
Exclusion criteria
Exclusion criteria: 1. It was diagnosed as acute promyelocytic leukemia; 2. Evidence of central nervous system invasion or brain neuropathy; 3. hepatitis B surface antigen (HBsAg) positive, hepatitis B core antibody (HBcAb) positive; Hepatitis C virus (HCV) antibody positive; Human immunodeficiency virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA positive; Syphilis antibody positive; 4. It is known that any ingredient used in the treatment of this study will produce allergic reactions; 5. Suffering from serious heart disease, including but not limited to severe arrhythmia, unstable angina pectoris, massive myocardial infarction, cardiac insufficiency of New York Heart Association Class III or IV Refractory hypertension (Refractory hypertension is defined as: on the basis of improving lifestyle, a reasonable and tolerable sufficient amount of >= 3 antihypertensive drugs (including diuretics) have been used for treatment>1 month, blood pressure still does not reach the standard or blood pressure can be effectively controlled by taking >= 4 antihypertensive drugs); 6. Those who have received or are ready to receive organ transplantation in the past (excluding hematopoietic stem cell transplantation); 7. Patients with acute and chronic graft versus host disease (GVHD); 8. Those who have received hematopoietic stem cell transplantation within 6 weeks before screening; 9. Active autoimmune or inflammatory diseases of the nervous system (such as Guillain-Barre syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and active cerebrovascular diseases of clinical significance (such as brain edema, posterior reversible encephalopathy syndrome (PRES)); 10. Participants in other clinical research within 3 months; 11. Subjects who have previously received other CAR-T treatment, cell therapy or any anti-CLL1 CD33 CD123 treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety index; | — |
Secondary
| Measure | Time frame |
|---|---|
| CAR-T in peripheral blood;complete response rate, CRR;overall response rate, ORR;duration of remission, DOR;Relapse-Free Survival, RFS;overall survival,OS;MRD Negative Rate;Median BM Reduction;Cytokine; | — |
Countries
China
Contacts
Public ContactJin Jie
Guangzhou Bio-gene Technology Co., Ltd
Outcome results
None listed