This study is a randomized, controlled, double-blind, multicenter, phase Ⅲ clinical study to evaluate the efficacy of IMM01(timdarpacept) in combination with azacitidine versus placebo in combination with azacitidine in patients with newly diagnosed chronic leukemia monocytic (CMML1-2).Primary endpoint are Complete remission rate and Overall survival.
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 and CMML-2;
Previous treatment with anti-CD47 monoclonal antibody/SIRPα fusion protein;
History of allogeneic stem cell transplant and other organ transplants; Patients who have undergone autologous haematopoietic stem cell transplant;
Prior diagnosis of: therapy-related Myelodysplastic syndrome / Myeloproliferative neoplasm(MDS/MPN); MDS evolved from a pre-existing Myelodysplastic syndrome / Myeloproliferative neoplasm (MDS/MPN) ;other MDS/MPN including atypical chronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML) and unclassifiable 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, extramedullary leukemia(excluding: Enlarged spleen, enlarged liver, enlarged lymph nodes), or myeloid sarcoma;