Study of Anti-CD33/CLL1 CAR-NK in Acute Myeloid Leukemia

Inclusion Criteria:

1. Subjects should voluntarily participate in this clinical study, are fully aware of thestudy, have signed the Informed Consent Forms, and are willing to follow and able tocomplete all trial procedures.
2. Subjects who are more than 18 years old (including 18 years old), and less than 75years old (including 75 years old);
3. Subjects who are diagnosed as AML according to the World Health Organization (WHO) 2016 diagnosis criteria, and meet any of the following:

• Relapsed acute myeloid leukemia: after complete response (CR), there are leukemiacells in peripheral blood or blast cells in bone marrow >5% (except for otherreasons such as bone marrow regeneration after consolidation chemotherapy) orextramedullary leukemia cell infiltration.
• Refractory acute myeloid leukemia: treatment-naive subjects who have no responseto the standard of care for 2 courses of treatment; subjects who are relapsedwithin 12 months with consolidated intensive treatment after CR; subjects who arerelapsed after 12 months but have no response to the conventional chemotherapy;subjects who are relapsed twice or more; subjects who have persistentextramedullary leukemia.

4. Subjects who are positive in CD33 or CLL1 test (according to the results of thecentral laboratory);
5. Subjects are allowed to have received ≤1 autologous HSCT;
6. Subjects whose performance status scores of the Eastern Cooperative OncologyOrganization (ECOG) are≤2;
7. Subjects with the expected survival phase>3 months;
8. Organ function should meet the following criteria:

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times theupper limit of normal (ULN), unless these are caused by leukemia cellinfiltration as determined by the investigator;
• Total serum bilirubin ≤ 1.5 times the upper limit of normal (ULN);
• Glomerular filtration rate (GFR)>50 mL/min;
• Left ventricular ejection fraction (LVEF)≥50%, no clinically significantpericardial effusion confirmed by echocardiography;
• Blood oxygen saturation under indoor ventilation in the screening phase>92%;

9. Female subjects of childbearing age must be negative in the pregnancy test results inthe screening phase;
10. Male and female subjects of childbearing age must agree to take effective birthcontrols after signing the informed consent forms, during the study, and within 6months after the last administration.

Exclusion Criteria:

1. Subjects who are known to have acute promyelocytic leukemia;
2. Subjects who suffer from or are suspected of suffering from central nervous systemleukemia, or central nervous system involvement;
3. Subjects who have received allogeneic HSCT;
4. Subjects who have prior II-IV (Glucksberg criteria) acute graft versus-host disease (GvHD) or extensive chronic GvHD;
5. Subjects who have received chimeric antigen receptor cell therapy or other celltherapy;
6. Subjects who have received anti-tumor therapy in the early stage but are not recoveredin the toxicity (according to NCI-CTCAE 5.0, the toxicity has not recovered to ≤ Grade 1, except for fatigue, anorexia, and alopecia);
7. Subjects who have had other malignant tumors within 5 years before inclusion, exceptfor any type of carcinoma in situ that has been cured in the past and cured skin basalcell carcinoma or skin squamous cell carcinoma;
8. Subjects whose cardiac function and disease meet one of the following conditionswithin 6 months before the first administration:

• Any risk factors that increase QTcF (Fridericia formula) interval prolongation,such as uncorrectable hypokalemia, hereditary long QT syndrome, and use of drugsthat prolong the QTcF interval;
• New York Heart Association (NYHA) classification ≥Grade 3;
• QTcF interval prolongation (male>450 milliseconds; female>470 milliseconds);
• Unstable angina pectoris, and myocardial infarction;

9. Subjects who have a history of autoimmune diseases (such as Crohn's disease,rheumatoid arthritis, systemic lupus erythematosus, etc.) that require systemicimmunosuppressive/systemic disease modulating drugs within 2 years before the firstadministration;
10. Subjects who have active systemic fungal, bacterial or viral infections that areuncontrolled or are required to be treated by intravenous administration;
11. Subjects with human immunodeficiency virus (HIV) antibody positive;
12. Subjects with HBsAg (-) and HBcAb (-). If subjects have HBsAg (+) and/or HBcAb (+),then subjects with HBV-DNA below the local lower limit of quantification can beincluded;
13. Subjects with hepatitis C virus antibody (-). If subjects have hepatitis C virusantibody (+), then subjects with HCV-RNA (-) can be included;
14. Female subjects who are breastfeeding and unwilling to stop breastfeeding;
15. Subjects who have received major surgery (for the definition of major surgery, referto the Level 3 and 4 surgeries specified in the Administrative Measures for theClinical Application of Medical Technology) within 28 days before the firstadministration.
16. Subjects who have received a solid organ transplant;
17. Subjects who have a history of alcohol, drug use or drug abuse;
18. Subjects who are known to be allergic to the study drug and/or main components and/orany excipients of the study drug;
19. Subjects who have other severe, acute, or chronic diseases or laboratory abnormalitiesthat may increase the risk of participating in the study and receiving the study drug,or may interfere with the interpretation of study results.