A Study to Evaluate Safety , Efficacy and Pharmacokinetics of WJ01024 Tablets Combined With Ruxolitinib in Patients With Myelofibrosis
Key claim: A Phase Ib/II trial is evaluating the safety, efficacy, and pharmacokinetics of WJ01024 tablets combined with ruxolitinib in medium-to-high-risk myelofibrosis patients with splenomegaly who have had poor response or intolerance to approved JAK inhibitors.
Abstract
This is a Phase Ib/II clinical study to evaluate the safety , efficacy and pharmacokinetics of WJ01024 tablets combined with Ruxolitinib tablets in patients with myelofibrosis.The study will be conducted in two phases: Phase 1b and Phase 2.Phase Ib is a dose extension study of WJ01024 tablets combined with ruxolitinib tablets. It is planned to recruit patients with medium to high-risk myelofibrosis accompanied by splenomegaly who have had poor response or intolerance to the previously approved JAK inhibitors for myelofibrosis. Phase II is the efficacy extension stage of WJ01024 tablets combined with ruxolitinib Tablets. It is planned to expand two groups of people. Group A will expand to recruit patients with medium-high risk of myelofibrosis accompanied by splenomegaly who have not responded well to the previously approved JAK inhibitors for myelofibrosis. Group B expanded to recruit patients with medium-high-risk myelofibrosis accompanied by splenomegaly who were intolerant after treatment with previously approved JAK inhibitors for myelofibrosis.
Why this matters
JAK-inhibitor-refractory or -intolerant myelofibrosis remains a major unmet need, and the ruxolitinib add-on/salvage portfolio continues to expand with novel investigational agents. WJ01024 joins a growing list of mechanistically diverse combination partners (selinexor, pelabresib, navitoclax, roginolisib, INCA033989, tasquinimod) being tested on the ruxolitinib backbone — though the undisclosed mechanism of WJ01024 limits mechanistic positioning at this early stage.