acute myeloid leukemia
Conditions
Interventions
experimental group:CLL1/CD33 CAR-T
Sponsors
The General Hospital of Western Theater Command
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. In patients diagnosed as acute myeloid leukemia, the myeloid target expression of leukemia cells is positive; 2. Patients with relapsed/refractory acute myeloid leukemia have poor response to conventional chemotherapy: 1) Those who have not achieved complete remission after 2 courses of treatment with standard induced remission regimen; 2) Relapse within 6 months after the first remission; 3) The patient relapsed 6 months after the first remission, but failed to be treated again with the original induced remission scheme; 4) Repeated relapses; 3. No central nervous system leukemia; 4. At least 2 weeks or 5 half lives (whichever is shorter) from the beginning of pretreatment chemotherapy after receiving systematic treatment in the past, except for inhibitors/agonists at immune checkpoint; Systemic immune checkpoint inhibitor/agonist treatment is at least 3 half lives away from pretreatment chemotherapy; 5. The toxic reaction caused by previous anti leukemia treatment must be stable and restored to = 1 level (except for the toxicity without clinical significance, such as baldness); 6. Over 18 years old and under 65 years old; 7. Physical strength score: 0~3 (ECOG standard); 8. No obvious active infection and graft versus host disease; 9. Expected life = 3 months; 10. Adequate kidney, liver, lung and heart functions, defined as: creatinine clearance rate (estimated by Cockcroft Gault formula)>60 mL/min; Serum ALT/AST = 2.5 ULN; Total bilirubin = 1.5 ULN, except for subjects with Gilbert's syndrome; Cardiac ejection fraction = 50%, no pericardial effusion was confirmed by echocardiography, and no clinically significant abnormality was found in ECG; No clinically significant pleural effusion; Baseline oxygen saturation under indoor ventilation>92%; 11. The serum pregnancy test results of women with fertility should be negative (women who have undergone surgical sterilization or menopause for at least 2 years believe that they have no fertility).
Exclusion criteria
Exclusion criteria: 1. Central system leukemia; 2. Subjects have suffered from other malignant tumors, non melanoma skin tumors, carcinoma in situ (such as cervix, bladder, breast), unless they have survived for at least 3 years without disease; 3. There are or suspected uncontrollable fungi, bacteria, viruses or other infections; 4. Known human immunodeficiency virus (HIV) infection; 5. The medical history of hepatitis B (HBsAg positive) or hepatitis C (HCV antibody positive) is known. The subjects with occult or pre infection of hepatitis B (defined as HBcAb positive, HBsAg negative) should be included in the group when the PCR detection of HBV DNA is negative; And these subjects need to conduct HBV DNA PCR every month. Subjects with positive HCV antibody serology, such as those with negative PCR results of HCV RNA, can also be included in the group; 6. Existing or previous CNS diseases, such as seizures, cerebral vascular ischemia/hemorrhage, dementia, cerebellar diseases or any CNS related autoimmune diseases; 7. Subjects with serious heart disease, such as uncontrollable or symptomatic arrhythmia, congestive heart failure, or myocardial infarction within 6 months before screening, or any cardiac function grade 3 (moderate) or grade 4 (severe) heart disease (according to NYHA functional classification method), and lymphoma infiltration in heart atrium or ventricle; 8. Have a history of myocardial infarction, cardiac angioplasty or stent implantation, unstable angina or other heart diseases with clinical significance within 12 months before enrollment; 9. It is expected or likely that an emergency will occur due to the rapid progress of the tumor within 6 weeks, which requires emergency treatment (such as tumor mass compression); 10. Primary immune deficiency; 11. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months before enrollment; 12. Any medical condition that may affect the evaluation of safety or efficacy; 13. Once had serious immediate hypersensitivity reaction to any drug to be used in this study; 14. Inoculate live vaccine = 6 weeks before starting the pretreatment scheme; 15. Pregnant or lactating female subjects; 16. Male or female subjects who do not agree to effective contraception from signing the informed consent to 6 months after completing CAR-T treatment; 17. Subjects and/or family members judged by the investigator are difficult to complete all visits or operations required by the study protocol (including follow-up visits), or the compliance to participate in this study is insufficient; 18. In the past 2 years, the subjects who suffered from terminal organ damage due to autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, and systemic lupus erythematosus), or who needed to systematically apply immunosuppressive drugs or other systemic disease control drugs had other malignant tumors, skin tumors other than melanoma, and cancers in situ (such as cervix, bladder, and breast), unless they had survived for at least 3 years without disease; 19. Participants in other clinical trials at the same time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| dose-limiting toxicity,DLT; | — |
Secondary
| Measure | Time frame |
|---|---|
| complete response,CR; | — |
Countries
China
Contacts
Public ContactHai Yi
The General Hospital of Western Theater Command
Outcome results
None listed