A Phase I/II Open-Label Study to Assess the Safety, Tolerability and Preliminary Efficacy of the Clever-1 Antibody Bexmarilimab in Combination with Standard of Care Therapy in Patients with Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia or Acute Myeloid Leukemia (BEXMAB Study)

Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome

Phase I - 1. Reporting of incidence and frequency of dose limiting toxicities (DLTs), and frequency and severity of adverse events (AE), SAEs and laboratory abnormalities., Phase II - 1. Preliminary efficacy will be investigated per indication as follows: - Complete response (CR) rate for MDS and CMML-2. - Overall response rate (ORR) for MDS and CMML failure to prior HMA. - CR for r/r AML. - CR rate for newly diagnosed AML.

Phase I - 1. Clinical efficacy measures include disease-specific response criteria and progression and survival analyses., Phase I - 2. PK samples at defined timepoints of single and repeat bexmarilimab administration and derived PK parameters., Phase I - 3. Anti-bexmarilimab antibody detection., Phase II - 1. Frequency and severity based on NCI-CTCAE v 5.0 grading of adverse events (AE), SAE and laboratory abnormalities., Phase II - 2. Extended preliminary efficacy to include disease-specific response criteria and progression and survival analyses., Phase II - 3. Anti-bexmarilimab antibody (immunogenicity) detection.

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