NCT06909136Active, not recruitingPhase 1/2
A Study to Evaluate Safety , Efficacy and Pharmacokinetics of WJ01024 Tablets Combined With Ruxolitinib in Patients With Myelofibrosis
A Phase Ib/II Clinical Study to Evaluate the Safety , Efficacy and Pharmacokinetics of WJ01024 Tablets Combined With Ruxolitinib Tablets in Patients With Myelofibrosis
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 33 (actual)
- First submitted
- 27 Mar 2025
- Start date
- Jul 2025
- Primary completion date
- Oct 2027
- Lead sponsor
- Suzhou Junjing BioSciences Co., Ltd.
- Diseases
- Myeloproliferative neoplasms
- NCT number
- NCT06909136
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 33
- From Jul 2025 to the primary completion date, Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with XPO1 inhibitors；
- Treatment with a powerful CYP3A inhibitor or inducer within 14 days prior to initial administration；
Other
- More than 10% blasts in peripheral blood or bone marrow；
- Unable to cooperate with or unable to perform MRI or CT scans as deemed necessary by sponsor and investigator；
Who the study is looking for
- 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；
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.