A Study to Assess Safety, Tolerability and Preliminary efficacy of Bexmarilimab in Combination with Standard of Care in Patients with Hematological Malignancies (BEXMAB)

Prior treatment

• Allogeneic transplantation less than 6 months prior screening.
• 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.

Other illness

• Patient with active auto-immune disorder (except type I diabetes, celiac disease, hypothyroidism requiring only hormone replacement, vitiligo, psoriasis, or alopecia).
• History of chronic ulcers or clinically relevant liver disease leading to Child Pugh Score C or higher.

Lab values

• Patient with acute promyelocytic leukemia (APL) or myeloproliferative CMML as defined by leukocyte count > 13 x10^9/L.

Age

• Eastern Cooperative Oncology Group (ECOG) performance status >2 (except newly diagnosed AML where ECOG 3 is allowed for patients < 75 years).

Other

• Pregnant or lactating women.

• 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.