First-in-Human Dose Escalation Study of AFM28 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Status:
Recruiting
Trial end date:
2026-03-01
Target enrollment:
Participant gender:
Summary
This study is a First In Human, phase 1, open-label, non-randomized, multi-center, multiple
ascending dose escalation study evaluating AFM28 as a monotherapy in subjects with
Relapsed/Refractory CD123-positive Acute Myeloid Leukemia (AML). AFM28 is a tetravalent
monoclonal antibody targeting the interleukin-3 receptor subunit alpha (IL3RA, CD123) and the
low affinity immunoglobulin gamma Fc region receptor III-A (FCGR3A, CD16A). It is developed
as an antineoplastic agent for hematologic malignancies known to express CD123. The primary
pharmacological Mode of Action of AFM28 is induction of cell death of CD123-expressing cells
by stimulating Antibody-Dependent Cell-mediated Cytotoxicity mediated by CD16A-expressing
immune cells, primarily Natural Killer cells. The aim of the dose escalation is to determine
the Maximum Tolerated Dose (MTD) and/or establish one or more Recommended Phase 2 Doses,
based on safety, preliminary anti-leukemic activity and Pharmacokinetics / Pharmacodynamics
data.