Safety, Tolerability and Pharmacokinetics of CSL360 in the Treatment of Acute Myeloid Leukemia

Phase I Study of CSL360 in Patients With Relapsed, Refractory or High-Risk Acute Myeloid Leukemia

Acute myeloid leukemia (AML) is a heterogeneous group of diseases characterized by uncontrolled proliferation of the myeloid line of white blood cells and impaired production of normal blood cells. If untreated, patients die of infection or bleeding usually in a matter of weeks. CSL360 is a neutralising monoclonal antibody which is believed to target the cells that are thought to drive AML but that are not effectively killed by standard treatment. The aims of the study are to determine a biologically active dose of CSL360 and generate understanding of a rational schedule of administration for future studies.

Inclusion Criteria:

• Clinical diagnosis of acute myeloid leukemia
• Recent bone marrow biopsy
• Prior treatment or medically unfit for standard therapy

Exclusion Criteria:

• Peripheral blood blast count > 30 x 109/L, or rapidly progressive AML
• Previous solid organ transplant
• Active GvHD or immunosuppression
• Concurrent treatment with other anti-cancer therapy
• Active infections