FDA Clears IND Application for CK0804 as Add-On Therapy to Ruxolitinib for Treatment of MF

The U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application from Cellenkos, Inc. to initiate a phase Ib, open-label study of CK0804 as an add-on therapy to ruxolitinib in patients with myelofibrosis (MF) who experience a suboptimal response to ruxolitinib.

CK0804 is a novel allogenic cell therapy product consisting of T-regulatory cells that exploit the CXCR4/CXCL12 axis and are derived from clinical-grade umbilical cord blood units. Since no human leukocyte antigen matching to the patient is required, CK0804 can be infused intravenously in an outpatient setting.

The phase Ib clinical trial is being launched by Cellenkos in partnership with Incyte as part of their LIMBER initiative (Leading in MPNs Beyond Ruxolitinib). The LIMBER-TREG108 study will examine the safety of monthly doses of CK0804 as add-on therapy in MF patients who will continue treatment with ruxolitinib.

Source: PR Newswire via Cellenkos Inc., June 2022