Study Explores Add-On Treatment CK0804 in Patients with Myelofibrosis

By Keightley Amen - Last Updated: June 8, 2023

A study presented at the American Society of Clinical Oncology annual meeting explored the safety and efficacy of infusion of adding allogeneic, cord blood (CB)-derived regulatory T cells (CK0804) to ruxolitinib in order to improve clinical outcomes in patients with MF.

“Almost 30% of patients have suboptimal response and disease remains incurable. Novel therapies are urgently needed,” according to the authors, led by Lucia Masarova, MD, of the Department of Leukemia at University of Texas MD Anderson Cancer Center in Houston.

“Recent data support the role of reactive cytokine- and chemokine-driven inflammatory fibrosis that contribute to MF pathogenesis. … Targeting bone marrow inflammation is emerging as potential therapeutic strategy for MF.”

The researchers are conducting a single-arm study with 24 subjects with MF who were receiving ruxolitinib for at least three months before enrollment but are unlikely to benefit from further ruxolitinib treatment. Each patient will receive a single infusion of CK0804 (100 million Treg cells) every 28 days, in addition to continuing ruxolitinib. As long as participants have no treatment-limiting toxicities, they will go on to receive up to six cycles every 28 days.

The study will follow up with patients for six months after the last CK0804 infusion. The researchers will examine overall response rate, length of response, and tolerability, as determined by adverse events and treatment-limiting toxicities. Specifically, the study will track anemia, spleen response, and symptom burden.

Masarova L, Huang M, Kadia TM, et al. Phase Ib, open-label study of add on therapy with CK0804 in participants with myelofibrosis, with suboptimal response to ruxolitinib. Abstract #210a. Presented at the 2023 American Society of Clinical Oncology Annual Meeting; June 2-6, 2023; Chicago, Illinois.

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