Phase I/II Clinical Trial of Axatilimab, a CSF1R Monoclonal Antibody, in Combination With Ruxolitinib as Therapy for Patients With Myelofibrosis (MF) and Chronic Myelomonocytic Leukemia (CMML)
Key claim: A phase I/II trial is testing axatilimab (a CSF1R monoclonal antibody) alone and with ruxolitinib to establish recommended dosing and whether the combination can control myelofibrosis and CMML.
Abstract
- To find the recommended dose of axatilimab given alone and in combination with ruxolitinib in patients with MF and CMML.
- To learn if axatilimab given in combination with ruxolitinib can help to control MF and CMML.
Why this matters
This trial introduces CSF-1R blockade combined with JAK inhibition as a shared therapeutic strategy for MF and CMML — two subtypes where monocyte/macrophage-driven inflammation contributes to disease biology (fibrosis-promoting macrophages in MF; defining monocytosis in CMML). It expands the axatilimab program beyond the parallel axatilimab ± azacitidine advanced-MPN/CMML trial by pairing CSF-1R with a JAKi backbone rather than an HMA, and it is one of a growing set of non-JAK immunomodulatory combinations (IL-1β, LGALS1, PD-1) being layered onto ruxolitinib in chronic-phase disease.