This is a first in human, prospective, multicenter, nonrandomized, open-label, dose-escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of repeat doses of CSL362.
Male or female aged 18 years or older. Previous diagnosis of CD123+ acute myeloid leukemia (AML), de novo or secondary. Completed and recovered from all planned induction and consolidation therapy according to the institution's standard of care, and achieved a complete remission (CR)/CR with incomplete platelet recovery (CRp); either first or second CR. Has factors conferring high risk of relapse. No plans for additional post-remission chemotherapy. Not currently a candidate for allogeneic hematopoietic stem cell transplant (HSCT).
Exclusion Criteria:
Diagnosis of acute promyelocytic leukemia (APL). Known leukemic involvement of the central nervous system. Life expectancy 4 months or less as estimated by the investigator. Concurrent treatment or planned treatment with other anticancer therapy (chemotherapy, immunotherapy, radiotherapy, targeted therapy, gene therapy).
