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

Launched by SUZHOU JUNJING BIOSCIENCES CO., LTD. · Mar 27, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment option for patients with myelofibrosis, a type of blood cancer that can cause symptoms like an enlarged spleen. Researchers want to learn about the safety and effectiveness of a medication called WJ01024 when combined with another drug, Ruxolitinib. The study will take place in two parts: the first part will test different doses to find out which is the best to use, and the second part will look at how well the combination works in treating myelofibrosis.

To participate in this trial, you need to be at least 18 years old and have a diagnosis of myelofibrosis that falls under certain criteria. You should also have an enlarged spleen and meet specific health requirements. During the trial, participants will receive the study medications and will be closely monitored for any side effects or changes in their condition. This trial is not yet recruiting participants, so if you're interested, it's best to keep an eye out for when it starts.

Gender

ALL

Eligibility criteria

• 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: MRI or CT scan showed spleen volume ≥450cm3 before the first medication;
• • Sufficient hematology and organ function;
• Exclusion Criteria:
• • More than 10% blasts in peripheral blood or bone marrow (accelerated or blast phase);
• • Previous treatment with JAK inhibitors for MF;
• • Previous treatment with XPO1 inhibitor;
• • 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;