A Phase 1/2 interventional study of Ruxolitinib phosphate tablet（Jakavi,NOVARTIS,9104733) in Intermediate- and High-risk Myelofibrosis (MF) Patients With Splenomegaly, sponsored by Suzhou Junjing BioSciences Co., Ltd.. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by Suzhou Junjing BioSciences Co., Ltd. · Phase 1/2, Interventional, and Treatment
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.
Ruxolitinib tablets have been approved in China since April 2017 as the first-line treatment for most intermediate- and high-risk myelofibrosis (MF) patients with splenomegaly. Compared with supportive treatment alone, ruxolitinib tablets have the efficacy of reducing spleen size and improving the symptoms of myelofibrosis, as well as reducing the risk of death and prolonging the survival of MF patients.Although the clinical efficacy of Ruxolitinib tablets has been confirmed, only about half of MF patients can achieve the ideal therapeutic effect (≥35% reduction in spleen volume and ≥50% improvement in disease symptoms at 24 weeks). Therefore, there is an urgent need for innovative drugs that can be combined with Ruxolitinib tablets to enhance therapeutic efficacy and meet clinical needs.
WJ01024 is a small molecule inhibitor of XPO-1, belonging to the same target small molecule compounds as Selinexor. Compared with Selinexor, the metabolism rate of this product is faster, which can reduce the toxicity in the body. In the Ba/F3-EPOR-JAK2-V617F cell model, the combination of this product and ruxolitinib tablets can enhance its anti-cell proliferation activity. In a clinical study initiated by researchers, this product has shown preliminary efficacy as a monotherapy in patients with myelofibrosis who have relapsed, are refractory to, or intolerant of JAK inhibitors, and is expected to have fewer toxic and side effects than drugs targeting the same site. Based on this, the following research is planned.
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.
Suzhou Junjing BioSciences Co., Ltd. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
If needed, additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the clinical trial.
Drug: Ruxolitinib phosphate tablet（Jakavi,NOVARTIS,9104733)
5-20mg BID (dosage per investigator judgement,JAKi intolerable pts will receive recuded dose of RUX(≥ 5mg BID),and suboptimal JAKi response pts will receive RUX of 15-20 mg BID）
AE
Incidence rate and severity of adverse events and serious adverse events,as well as abnormal changes in clinical significance laboratory tests and other examinations
Time frame: 3 years
SVR35
At weeks 12 and 24, the ratio of splenic volume reduction ≥35% (SVR35) was assessed by the investigator
Time frame: 3 years
The absolute value changes of the total symptom score in MPN-SAF-TSS
The absolute value changes of the overall symptom score in MPN-SAF-TSS based on subject assessment in weeks 12 and 24 compared with the baseline
Time frame: 3 years
The blood concentration of WJ01024
AUC of WJ01024,C1D1,C2D1,C4D1,C6D1 1 h after WJ01024 administration Both in phase Ib and II
Time frame: 1.5 years
Incidence rate and severity of adverse events nd serious adverse events
Incidence and severity of adverse events nd serious adverse events,as well as abnormal changes in clinical significance laboratory tests and other examinations
Time frame: 3 years
Anemia response rate
Anemia response rate at Week 12 and Week 24 as assessed by the investigator according to IWG-MRT criteria
Time frame: 3 years
ORR：CR + PR + clinical improvement
Overall response rate (ORR, CR + PR + clinical improvement) as determined by the investigator according to IWG-MRT criteria
Time frame: 3 years
PFS
PFS as assessed by the investigator
Time frame: 3 years
OS
Overall survival
Time frame: 3 years
LDH
Evaluation of changes in serum LDH levels
Time frame: 3 years
Phase II：The rate of a reduction of ≥50% in the total symptom score in MPN-SAF-TSS
The rate of a reduction of ≥50% in the overall symptom score in MPN-SAF-TSS based on subject assessment in weeks 12 and 24 compared with the baseline
Time frame: 3 years
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Suzhou Junjing BioSciences Co., Ltd.