OncoMatch/Clinical Trials/NCT05423691
Leading in MPNs Beyond Ruxolitinib in Combo With T-Regs
Is NCT05423691 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies CK0804 for myelofibrosis.
Treatment: CK0804 — To assess the safety and tolerability of CK0804 as add-on therapy in participants with myelofibrosis, with suboptimal response to ruxolitinib
Check if I qualifyExtracted eligibility criteria
Cancer type
Myeloproliferative Neoplasm
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: JAK inhibitor (ruxolitinib)
Subject has been receiving ruxolitinib therapy, is unlikely to benefit from further ruxolitinib monotherapy in the opinion of the investigator; AND meeting the following criteria: receiving ruxolitinib >3 months prior to enrollment; AND stable dose for 8 weeks before starting therapy with CK0804
Cannot have received: allogenic or autologous stem cell transplantation
Undergone any prior allogenic or autologous stem cell transplantation or a candidate for such transplantation
Cannot have received: chemotherapy
Exception: with the exception of ruxolitinib
Received chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody or hypomethylating agent to treat the participant's disease, with the exception of ruxolitinib, within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment
Cannot have received: splenic irradiation
Participant has received splenic irradiation within the past 6 months
Lab requirements
Blood counts
Platelets < 50 × 10^9/L without the assistance of growth factors, thrombopoietic factors, or platelet transfusions; ANC < 0.5 × 10^9/L
Kidney function
Creatinine clearance < 50 mL/min according to Cockcroft-Gault formula
Liver function
ALT ≥ 2.5 × ULN; AST ≥ 2.5 × ULN; Direct Bilirubin > 2.0 × ULN; ALP ≥ 3 × ULN
Participants with laboratory values at screening as defined: Platelets < 50 × 10^9/L without the assistance of growth factors, thrombopoietic factors, or platelet transfusions; ANC < 0.5 × 10^9/L; ALT ≥ 2.5 × ULN; AST ≥ 2.5 × ULN; Direct Bilirubin > 2.0 × ULN; ALP ≥ 3 × ULN; Creatinine clearance < 50 mL/min according to Cockcroft-Gault formula.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UC Davis Health · Sacramento, California
- Columbia University · New York, New York
- Montefiore Einstein Cancer Center · The Bronx, New York
- The University of Texas MD Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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