Cellenkos has signed a sponsored research agreement with the Icahn School of Medicine at Mount Sinai Hospital, New York, US, to investigate the use of CK0804, a T-regulatory cell therapy for myelofibrosis.

The collaboration aims to explore the therapeutic potential of CK0804, an allogeneic, cord blood-derived T-regulatory cell product enriched with C-X-C chemokine receptor type 4.

The research will be led by Ronald Hoffman, director of the Myeloproliferative Disorders Research Program at the Tisch Cancer Institute, Mount Sinai.

CK0804 uses Cellenkos’ CRANE technology to create disease-specific cell therapy products. This approach allows CK0804 cells to preferentially target inflamed bone marrow.

Cellenkos chief operating officer Tara Sadeghi stated: “We are very excited by our collaboration with Mount Sinai and eagerly anticipate gaining a deeper understanding of [how] mechanisms of CK0804 Tregs work in myelofibrosis, especially to decrease inflammation.

“CK0804 is already in a Phase I clinical trial to examine its safety and efficacy in patients with myelofibrosis who have a suboptimal response to the JAK2 inhibitor, ruxolitinib. We are particularly intrigued by the possibility of using CK0804 in treatment-naïve myelofibrosis patients, as well as in combination with other approved therapies, including ruxolitinib, momelotinib, pacritinib and fedratinib.”

A Phase Ib trial is currently underway, evaluating the safety and efficacy of multiple doses of CK0804 in myelofibrosis patients.

Preliminary results indicate improvements in blood transfusion requirements, reduction in spleen volume and symptom burden.

CK0804 can be administered in an ambulatory setting without the need for lymphodepletion or immune suppression.

The trial is recruiting at several institutions, including the Albert Einstein Hospital in the Bronx, New York; the MD Anderson Cancer Center in Houston, Texas; and the University of California Davis in Sacramento.

The research could enable a new, accessible treatment for myelofibrosis.

In February 2024, Cellenkos announced positive data from its CK0803 neurotrophic T regulatory cell therapy to treat individuals with amyotrophic lateral sclerosis.

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