A Study of QLF32101 in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

Exclusion Criteria

• •1. Previously received hematopoietic stem cell transplantation;
• •2. Previous exposure to any anti-CLL-1 monoclonal antibody or CAR-T cell therapy;
• •3. Use other intervention study drugs within 4 weeks before the first use of the drug;
• •4. Any anti-tumor treatment received within 4 weeks before the first use of the drug;
• •5. Plan to vaccinate live attenuated vaccine within 4 weeks before the first use of the drug or during the study period;
• •6. Have received systemic glucocorticoid or other immunosuppressive therapy within 14 days before the first use of the drug;
• •7. With known central nervous system (CNS) leukemia infiltration;
• •8. ECG examination during screening period showed that QTcF\>450 ms for males and 470 ms for females;
• •9. Major organ surgery within 4 weeks before the first use of the drug;
• •10. Received radiotherapy within 4 weeks before the first use of the drug;
• •11. There is an active infectious disease with clinical significance, which needs intravenous antibiotic treatment, and the investigator and sponsor judge that the patient is not suitable to participate in the clinical trial;
• •12. Chronic or acute active hepatitis B virus or hepatitis C virus infection;
• •13. Known active tuberculosis or active syphilis;
• •14. Known history of human immunodeficiency virus (HIV) infection；
• •15. Have received immunotherapy and have ≥ grade 3 immune related adverse events (irAE);
• •16. History of serious cardiovascular and cerebrovascular diseases;
• •17. History of other malignant tumors within 5 years before enrollment;
• •18. Breastfeeding patients；
• •19. Patients with known prior hypersensitivity to human or humanized monoclonal antibodies, or hypersensitivity to any of the components of QLF32101；
• •20. Have uncontrollable concomitant diseases or other diseases judged by the investigator to be unsuitable for participation in this study.