A Study of IMM01 Combined With Azacitidine in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

Exclusion Criteria

• •1. Received anti-CD47 antibody or SIRPα fusion protein research drugs.
• •2. Who has received allogeneic hematopoietic stem cell transplantation and other organ transplants; Autologous hematopoietic stem cell transplantation less than six months.
• •3. Central nervous system leukemia orcentral nervous system invasion.
• •4. Developed other malignant tumors within 5 years prior to enrollment.Except:
• •Cured carcinoma in situ and non-melanoma skin cancer of the cervix; Complete remission of disease at least 2 years prior to initial administration and no need for antineoplastic therapy.
• •5. Patients with a history of active autoimmune diseases;
• •6. Major surgery within 4 weeks prior to initial treatment;
• •7. Subjects requiring systemic corticosteroids (equivalent to \>10 mg prednisone/day) or other immunosuppressive agents within 14 days prior to initial treatment or during the study period;
• •8. Hypertension (systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg) or pulmonary hypertension or unstable angina that is also not controlled by medication;
• •9. Patients with a history of arterial or deep vein thrombosis within the 6 months prior to enrollment, or evidence or history of bleeding tendency within the 2 months prior to enrollment, regardless of severity.
• •10. Severe gastrointestinal diseases;
• •11. With acute lung disease, pulmonary fibrosis, Severe dyspnea, lung insufficiency or continuous oxygen inhalation.
• •12. Patients who have been severely infected within 4 weeks prior to initial administration;
• •13. Active hepatitis B or hepatitis C ; human immunodeficiency virus (HIV) antibody is positive.
• •14. Live attenuated vaccine should be administered within 4 weeks prior to initial administration.
• •15. Patients with a history of severe allergy to protein drugs (CTCAE V5.0 grade \> 3); Or the patient is allergic to azacytidine.
• •16. Participate in clinical trials of other drugs 28 days prior to initial dosing.
• •17. A history of prior neurological or mental disorders, such as epilepsy, dementia, or alcohol, drug or substance abuse, affects compliance.
• •18. Other conditions that the investigator considers inappropriate for participation in this clinical trial.