CK0804

CK0804 is an investigational, allogeneic, off-the-shelf T-regulatory (Treg) cell therapy developed by Cellenkos for the treatment of myelofibrosis. The product consists of Treg cells enriched for the chemokine receptor CXCR4, which enables them to home efficiently to sites of inflammation in the bone marrow and spleen where its ligand CXCL12 is overexpressed. By leveraging the CXCR4/CXCL12 axis, CK0804 suppresses inflammatory cytokines implicated in myelofibrosis pathogenesis and acts through multiple mechanisms including cytokine depletion (such as IL-2), secretion of suppressor cytokines like interleukin-10, and cytotoxic suppression of harmful immune cells. Clinical studies have shown that CK0804 can reduce spleen volume, decrease transfusion requirements, improve symptom burden (including fatigue and early satiety), and lower levels of pro-inflammatory biomarkers such as TGFβ. It is administered without lymphodepletion or HLA matching as a cryopreserved infusion every four weeks alongside ruxolitinib in patients with suboptimal response to JAK inhibitors[1][5][6].