A Study to Assess Safety, Tolerability and Preliminary Efficacy of Bexmarilimab in Combination With Standard of Care in Patients With Hematological Malignancies

Inclusion Criteria:

* Patient ≥ 18 years of age who presents with one of the following conditions:

  * Morphologically confirmed diagnosis of MDS with revised International Prognostic Scoring System (rIPSS) risk categories: intermediate, high and very high.
  * Morphologically confirmed diagnosis of CMML-2 with indication for azacitidine treatment.
  * CMML and MDS patient with response failure to HMA or therapy regimen including HMA.
  * Morphologically confirmed diagnosis of r/r AML following at least 1 line of prior therapies with indication for azacitidine treatment.
  * Morphologically confirmed diagnosis of AML in patients unfit for induction therapy with indication for azacitidine-venetoclax treatment.
* Leukocyte count \< 20 x10\^9/L (\< 25 x10\^9/L for newly diagnosed AML). Hydroxycarbamide use is permitted to meet this criterion in MDS and AML but not in CMML.
* Adequate renal function.
* Adequate liver function.

Exclusion Criteria:

* Patient with acute promyelocytic leukemia (APL) or myeloproliferative CMML as defined by leukocyte count \> 13 x10\^9/L.
* Eastern Cooperative Oncology Group (ECOG) performance status \>2 (except newly diagnosed AML where ECOG 3 is allowed for patients \< 75 years).
* Allogeneic transplantation less than 6 months prior screening.
* Patient with active auto-immune disorder (except type I diabetes, celiac disease, hypothyroidism requiring only hormone replacement, vitiligo, psoriasis, or alopecia).
* The patient requires systemic corticosteroid (≥10 mg/day prednisone or equivalent) or other immunosuppressive treatment.
* Less than 21 days since the last dose of intravenous anticancer chemotherapy or less than 14 days or five half-lives (whichever is shorter) from a small molecule targeted therapy or oral anticancer chemotherapy before the first study treatment.
* Any immunotherapy or investigational therapy within preceding 28 days from the first study treatment.
* Pregnant or lactating women.
* History of chronic ulcers or clinically relevant liver disease leading to Child Pugh Score C or higher.