Active — Not RecruitingPhase 1/2

A Study to Evaluate Safety , Efficacy and Pharmacokinetics of WJ01024 Tablets Combined With Ruxolitinib in Patients With Myelofibrosis

China33 participantsStarted 2025-07-28

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subjects voluntarily participate in the study after receiving full informed consent and sign informed consent; * Age ≥18 years old, gender unlimited; * Patients diagnosed with primary myelofibrosis (PMF) according to WHO criteria (2016 edition), or with ET secondary myelofibrosis (PET-MF) or PV secondary myelofibrosis (PPV-MF) according to International Working Group on Myelofibrosis Research and Treatment (IWG-MRT) criteria; They could be included regardless of JAK2 mutation； * Participants with international prognostic scoring system (DIPSS) risk category of intermediate-1, or intermediate-2, or high-risk； * ECOG score 0\~2; * No stem cell transplantation plan in the near future; * Spleen enlargement:palpable splenomegaly(≥5cm below left costal margin)or radiologically confirmed spleen volume ≥450 cm\^3 using MRI/CT; * Patients with intolerance or a suboptimal response to prior JAK inhibitor therapy； * Sufficient hematology and organ function； Exclusion Criteria: * More than 10% blasts in peripheral blood or bone marrow； * Previous treatment with XPO1 inhibitors； * Unable to cooperate with or unable to perform MRI or CT scans as deemed necessary by sponsor and investigator； * Treatment with a powerful CYP3A inhibitor or inducer within 14 days prior to initial administration；

What they're measuring

Timeframe: 3 years

SVR35

Timeframe: 3 years

The absolute value changes of the total symptom score in MPN-SAF-TSS

Timeframe: 3 years

Trial details

NCT IDNCT06909136

SponsorSuzhou Junjing BioSciences Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-10-31

View on ClinicalTrials.gov More Intermediate- and High-risk Myelofibrosis (MF) Patients With Splenomegaly trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.