IMM01+Azacitidine VS Placebo +Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2)

Inclusion Criteria:

• Age ≥ 18 years old, regardless of gender;

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.

• Life expectancy ≥ 12 weeks;

• Patients with CMML diagnosed according to WHO 2016 criteria, including CMML-1 andCMML-2;

• White blood cell count ≤ 13×10⁹/L before the first treatment with the study drug (hydroxyurea and leukapheresis are allowed, but not within 3 days prior to the firsttreatment with the study drug).

• Patients must be treatment-naïve to any hypomethylating agents (e.g., azacitidine,decitabine), chemotherapy or allogeneic stem cell transplant for CMML.Immunomodulators ( lenalidomide), immunosuppressants (antithymocyte globulin,cyclosporine), targeted agents (ruxolitinib), etc. are also excluded, as theseagents are considered disease-modifying therapies. Note: During screening and studyparticipation, subjects may continue oral corticosteroids for diseases other thanCMML (e.g. asthma) at a stable daily dose equivalent to ≤ 10 mg prednisone. Inaddition, supportive care in the form of blood transfusions or growth factors is notconsidered prior therapy in this case and is permitted prior to and as needed duringthe study.

Exclusion Criteria:

• Previous treatment with anti-CD47 monoclonal antibody/SIRPα fusion protein;

• History of allogeneic stem cell transplant and other organ transplants; Patients whohave undergone autologous haematopoietic stem cell transplant;

• Prior diagnosis of: therapy-related myelodysplastic syndrome(t-MDS); MDS evolvedfrom a pre-existing myeloproliferative neoplasm (MPN) ;MDS/MPN including atypicalchronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML) andunclassifiable MDS/MPN. Patients positive for BCR-ABL fusion genes, PDGFRA, PDGFRB,and FGFR1 rearrangements need to be excluded;

• Current or history of central nervous system (CNS) leukemia, extramedullaryleukemia, or myeloid sarcoma;

• Diagnosis of other malignant neoplasms within 3 years prior to the first dose.Exceptions: a. Radically treated cervical carcinoma in situ or non-melanoma skincancer; b. a second primary cancer that has been curatively treated and has norecurrence within three years;