See Intervention Description

CSL362 is humanized monoclonal antibody that targets the alpha chain of the interleukin 3 receptor (IL3Rα; also known as CD123) and is optimised for enhanced activation of antibody-dependent cell-mediated cytotoxicity (ADCC) via natural killer cells.

CSL362 is a sterile solution for injection and will be administered by intravenous infusion to subjects in sequential, escalating dose level cohorts, at doses up to 12.0 mg/kg. CSL362 will be administered every 14 days for a total of 6 infusions per subject. The 6 infusions for each individual subject will contain the same dose of CSL362.

Number of subjects reporting any AEs and the severity of those AEs.

Number of participants with DLT.

Dose-limiting toxicity (DLT) is defined as:

• A non-hematological toxicity grade 3 or worse.
• A hematological toxicity grade 3 that does not recover to baseline within 14 days.
• A hematological toxicity grade 4 or worse according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V4.0.

PK Parameters comprise:

• Area under the serum concentration time curve (AUC) from time point zero (before dosing):

  • to the time point at which the analyte first returns to baseline (AUC0-last)
  • to a meaningful time after infusion (AUC0-y)
  • extrapolated to infinity (AUC0-∞).

• The maximum observed serum concentration (Cmax).

• First time to reach maximum concentration in serum (Tmax).

• Terminal serum half-life (t 1/2)