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

NCT06909136 | Active Not Recruiting Phase 1

• 1 other identifier: JS110-003-Ib/II
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intermediate- and High-risk Myelofibrosis (MF) Patients With Splenomegaly

Outcome Measures

Primary Outcomes (3)

• 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

  3 years

• SVR35

  At weeks 12 and 24, the ratio of splenic volume reduction ≥35% (SVR35) was assessed by the investigator

  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

  3 years

Secondary Outcomes (8)

• The blood concentration of WJ01024

  1.5 years

• Incidence rate and severity of adverse events nd serious adverse events

  3 years

• Anemia response rate

  3 years

• ORR：CR + PR + clinical improvement

  3 years

• PFS

  3 years

Study Arms (1)

WJ01024 tablet

EXPERIMENTAL

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)

Interventions

Ruxolitinib phosphate tablet（Jakavi,NOVARTIS,9104733) DRUG

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）

WJ01024 tablet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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；

You may not qualify if:

• 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；

Sponsors & Collaborators

• Suzhou Junjing BioSciences Co., Ltd.: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Zhengzhou, 450000, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Open trial
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study consisted of two phases: Phase Ib and Phase II. Phase Ib was dose expansion of WJ01024 tablets combined with Ruxolitinib tablets. Phase II was efficacy expansion of WJ01024 tablets combined with Ruxolitinib tablets.

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 3, 2025
• Study Start: July 28, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): May 15, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

CN (1)