This is a study to assess the safety of increasing dose levels of bexmarilimab when combined with standard of care (SoC) in patients with myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) or acute myeloid leukemia (AML); Phase 1 aims to identify the recommended phase 2 dose (RP2D) of bexmarilimab based on safety, tolerability and pharmacological activity; Phase 2 will investigate the preliminary efficacy of the combination treatment in selected indications from Phase 1.
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Reporting of incidence and frequency of dose limiting toxicities (DLTs).
Timeframe: From study start to end of Cycle 1 (each cycle is 28 days)
Frequency and severity based on NCI-CTCAE grading of treatment emergent AEs and serious adverse events (SAE).
Timeframe: From study start to 30 days after end of treatment (EOT)
Complete response (CR) rate for MDS and CMML-2.
Timeframe: From study start to 30 days after EOT
Overall response rate (ORR) for MDS and CMML failure to prior HMA.
Timeframe: From study start to 30 days after EOT
Complete remission with incomplete blood recovery (CRi) for r/r AML.
Timeframe: From study start to 30 days after EOT
Minimal residual disease (MRD) status for newly diagnosed AML.
Timeframe: From study start to 30 days after EOT