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).

• Patients must be treatment-naïve to any systemic agents for CMML (e.g., azacitidine,decitabine,chemotherapy<1 cycle, and the washout period should be more than 28 days,which is acceptable.), allogeneic stem cell transplant for CMML. Note: Duringscreening and study participation, subjects may continue oral corticosteroids fordiseases other than CMML (e.g. asthma) at a stable daily dose equivalent to ≤ 10 mgprednisone. In addition, supportive care in the form of blood transfusions or growthfactors is not considered prior therapy in this case and is permitted prior to andas needed during the 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 / Myeloproliferativeneoplasm(MDS/MPN); MDS evolved from a pre-existing Myelodysplastic syndrome /Myeloproliferative neoplasm (MDS/MPN) ;other MDS/MPN including atypical chronicmyeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML) and unclassifiableMDS/MPN. Patients positive for BCR-ABL fusion genes, PDGFRA, PDGFRB, and FGFR1rearrangements need to be excluded;

• Current or history of central nervous system (CNS) leukemia, extramedullaryleukemia(excluding: Enlarged spleen, enlarged liver, enlarged lymph nodes), ormyeloid 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,Surgery-cured prostate cancer and papillary thyroid cancer; b. a secondprimary cancer that has been curatively treated and has no recurrence within threeyears;