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;
Parallel
IMM01
DrugIV infusion
Azacitidine
Drugsubcutaneous injection
Placebo
DrugIV infusion
Complete remission( CR) rate
CR rate: CR rate determined by Independent Review Committee (IRC) based on IWG2006 MDS efficacy evaluation criteria;
Overall survival (OS)
Overall survival (OS): Time from randomization to death from any cause;
Event-free survival(EFS)
Time from randomization to transformation to AML or death from any cause, whichever occurs first
Progression-free survival(PFS)
Time from randomization to transformation to AML or death from any cause, whichever occurs first
Time to response (TTR)
time from first dose to first occurrence of CR, partial remission (PR), marrow complete remission (mCR) ± hematologic improvement (HI), HI, assessed by IRC and investigators, respectively
overall response rate(ORR)
is defined as the proportion of the analysis population achieving CR, PR, mCR±HI, or HI
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