A Study of CSL362 in Patients With CD123+ Acute Myeloid Leukemia Currently in Remission

A Phase 1 Study of CSL362 (Anti-IL3Rα / Anti-CD123 Monoclonal Antibody) in Patients With CD123+ Acute Myeloid Leukemia in Complete Remission or Complete Remission With Incomplete Platelet Recovery at High Risk for Early Relapse

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.

Inclusion Criteria:

• 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).