First Patient Dosed in Treg Cell Therapy Trial for Myelofibrosis


CKO804 is being evaluated as an add-on therapy to ruxolitinib in patients whose disease had a suboptimal response to ruxolitinib alone.

Cellenkos has dosed the first patient with myelofibrosis with CK0804 regulatory T-cells (Treg cells) as an add-on therapy to ruxolitinib (Jakafi; Incyte) in the LIMBER-TREG108 trial, a collaboration between Cellenkos and Incyte.

"This is an exciting milestone for our company. The initiation of this study of CK0804 as on add on therapy to ruxolitinib is an important achievement that brings us closer to delivering a potential new treatment which may have a life-changing impact for myelofibrosis patients who have less than optimal response to treatment with ruxolitinib," Tara Sadeghi, chief operating officer, Cellenkos, said in a statement. "Myelofibrosis patients who do not respond to ruxolitinib have limited treatment options and can progress to leukemia. This experimental immunotherapy treatment in combination with the standard of care may represent a new hope for the patients with myelofibrosis potentially enhancing the efficacy of current JAK inhibitor therapy while also offering possible immune modulation and restoration of impacted hematopoiesis."

CK0804 is an allogeneic, CXCR4 enriched, Treg therapy developed with Cellenkos' proprietary CRANE technology. It is derived from umbilical cord blood units, from which multiple doses can be manufactured from a single unit. The therapy is being evaluated in up to 6 monthly doses for safety, tolerability, and efficacy in the multicenter phase 1b LIMBER-TREG108 trial being conducted at The University of Texas MD Anderson Cancer Center, The University of Columbia Hospital and University of California, Davis, under principal investigator Lucia Masarova, MD, assistant professor of Leukemia, MD Anderson.

The study will begin with an open-label safety run-in of 9 patients and progress into an expansion cohort of 15 additional patients. The study’s primary endpoint is treatment-limiting toxicities, as defined by severe (grade 3 or 4) infusion-related toxicity within 24 hours of treatment that does not resolve with standard of care treatment within 72 hours, or treatment-related death within 28 days. Secondary outcome measures include overall response rate, rate of anemia response, rate of spleen response, and the percentage of patients with symptom reductions of at least 50% as measured by the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score.

"We are pleased that the first patient first dose milestone in the LIMBER-TREG108 study – one of several studies in our LIMBER clinical program evaluating multiple monotherapy and combination strategies to improve and expand treatments for patients with MPNs – has been achieved. We look forward to the results of the study, and to continuing our partnership toward important scientific advances for these patients," Ekaterine Asatiani, MD, Division Vice President and Head, Early Development, Incyte, added to the statement.

Cellenkos announces first patient dosed with CK0804 cell therapy in LIMBER-TREG108 clinical trial. News release. Cellenkos. January 6, 2023.
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