Drug intelligence / Profile preview

CK0804 + ruxolitinib

Development stage
Unknown
Lead developer
Cellenkos
Modality
Cell Therapies, Small Molecules
Administration
Intravenous, Oral
01

Overview

CK0804 + ruxolitinib is an investigational **combination therapy** being evaluated for the treatment of **myelofibrosis** in patients who have a suboptimal response to ruxolitinib alone. **CK0804** is an allogeneic, off-the-shelf, donor-derived, CXCR4-enriched regulatory T cell (Treg) therapy developed using Cellenkos’ proprietary CRANE technology. These Treg cells harness the **CXCR4/CXCL12 (SDF-1) axis** to suppress pro-inflammatory cytokines implicated in myelofibrosis, potentially reducing chronic inflammation and improving dysregulated immune responses. **Ruxolitinib** is a small molecule **Janus kinase (JAK) 1/2 inhibitor** approved for myelofibrosis and polycythemia vera. The combination is administered as continued oral ruxolitinib therapy plus intravenous infusions of CK0804 (fixed dose of 100 million Treg cells every 28 days, up to six doses). Early (phase 1b) clinical results indicate promising symptom improvement, reduced spleen volume, and transfusion dependence, with a favorable safety profile for the combination in heavily pretreated patients with myelofibrosis[1][3][4][6][7].

Other names
LIMBER-TREG108LIMBER-TREG-108LIMBER-TREG 108
02

Targets

TYK2 (Tyrosine kinase 2)JAK2 (Janus kinase 2)CXCL12 (C-X-C motif chemokine ligand 12)JAK1 (Janus kinase 1)JAK3 (Janus kinase 3)

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