MF With SplenomegalyPhase 1NCT07802405
Evaluating Safety ,Tolerability, Pharmacokinetic,Efficacy of WJ01024 or WJ01024 Combined With Ruxolitinib in Patients With Myelofibrosis
A Phase 1 study testing WJ01024 tablet in people with MF With Splenomegaly, run by Henan Cancer Hospital at 1 site in China.
Trial summary
This is a Phase I clinical study to evaluate the safety and tolerability, pharmacokinetic characteristics and preliminary efficacy of oral WJ01024 administered as monotherapy and in combination with ruxolitinib in patients with myelofibrosis（MF）. The study will be conducted in two phases: Phase IA and Phase IB. Read more about this study
- Who is it for?
- Ages 18 days and older
- Conditions the study is for
- MF With Splenomegaly
- What is being tested?
- WJ01024 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 21 Nov 2023to 21 Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The subjects voluntarily participated in this study after obtaining full informed consent and signed the informed consent form.
- Age ≥18 years old, gender not limited;
- Patients diagnosed with primary myelofibrosis (PMF) according to the 2016 World Health Organization (WHO) criteria, or patients diagnosed with post-essential thrombocythemia MF (PET-MF) or post-polycythemia vera MF (PPV-MF) according to International Working Group for Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria;
- Patients evaluated as intermediate-1, intermediate-2, or high-risk according to the International Prognostic System (DIPSS) scoring system;;
- Expected life expectancy is ≥ 24 weeks;
- Eastern Cooperative Oncology Group (ECOG) score of 0-2 ;
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- No planned for stem cell transplantation in the near future.
- Splenomegaly: Palpation of the spleen margin reaches or exceeds at least 5cm below the costal margin (the distance from the costal margin to the farthest point of the spleen protrusion), or spleen volume ≥450cm ³ by CT or MRI.
- Adequate hematological and organ function within 7 days before the first administration of the study drug (no RBC transfusion, growth factors, colony-stimulating factors, platelet-generating factors ,or platelet transfusion within 14 days before the testing) :
- Absolute neutrophil count (ANC) ≥1.5×109/L;
- Platelet count ≥75×109/L(Phase IA); Platelet count ≥100×109/L(Phase IB); Hemoglobin ≥ 8.0g /dL; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0× upper limit of normal (ULN); Total bilirubin ≤1.5×ULN; Creatinine ≤1.5×ULN.
- For women of childbearing age, within 7 days before the first administration, if the serum pregnancy test is confirmed to be negative and they agree to use effective contraceptive measures during the study drug period and within 90 days after the last administration. For male subjects whose sexual partners are women of childbearing age, they must agree to take effective contraceptive measures during the use of the study drug and within 90 days after the last administration.
Who cannot join
- Peripheral blood blasts >5% or Bone marrow blasts >10%.
- 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 strong CYP3A inhibitors or inducers within 14 days prior to initial administration"
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Zhou Hu, PhD., 13939068863, papertigerhu@163.com
Zhou Hu, Ph.D.
About this study
Official title: A Phase I Clinical Study Evaluating the Safety and Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of Oral Administration of WJ01024 as a Monotherapy and in Combination With Ruxolitinib in Patients With Myelofibrosis
This is a Phase I clinical study to evaluate the safety and tolerability, pharmacokinetic characteristics and preliminary efficacy of oral WJ01024 administered as monotherapy and in combination with ruxolitinib in patients with myelofibrosis（MF）. The study will be conducted in two phases: Phase IA and Phase IB.
Phase IA is a dose-escalation and dose-expansion study of WJ01024 monotherapy in patients with MF after failure of JAK inhibitor (JAKi) therapy (relapsed/refractory/intolerant). Phase IB is a dose-escalation and dose-expansion study of WJ01024 in combination with ruxolitinib in JAKi-naïve patients with intermediate- or high-risk MF.
Read the detailed description
Phase IA is a dose-escalation and dose-expansion study of WJ01024 monotherapy in patients with MF after failure of JAK inhibitor (JAKi) therapy (relapsed/refractory/intolerant).Dose escalation is carried out by combining accelerated titration and the traditional 3+3 design. During the accelerated titration phase, if no dose-limiting toxicity (DLT) and no ≥2 episodes of grade ≥2 treatment-related adverse events (TRAEs) occur within the first cycle (DLT observation period), no further subjects are enrolled at that dose level, and the study proceeds to the traditional 3+3 phase starting with the 60 mg group. At present, it is expected that the dose will be increased in four groups . If the researchers elects to explore intermediate doses or higher doses during the trial, adjustments will be made based on the actual situation. It is planned to expand the dosage by two groups. The final expanded dosage will be determined based on emerging safety and efficacy data. Dose escalation is stratified by background therapy (with vs. without background medication). Phase IB involves dose escalation and dose expansion studies of WJ01024 combined with ruxolitinib. Phase IB is planned to be conducted in JAKi-naïve patients with intermediate- or high-risk MF. Initiation of Phase IB requires that the group in Phase IA has completed the DLT observation period. Two combination dose groups are planned. Intermediate or higher doses may be explored at the investigator's discretion.Two combination dose levels are planned for expansion ;final expansion dose(s) will be determined based on emerging safety and efficacy data.
- Conditions
- MF With Splenomegaly
- Being tested
- WJ01024 tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WJ01024 tabletDrug
5-20mg BID (dosage per investigator judgement)
| Study group | Role | What they receive |
|---|---|---|
| WJ01024 tablet | Experimental | Not described Receives: Drug: WJ01024 tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
Incidence of DLT
Measured: 12 months
AE
incidence and severity of adverse events(AEs) and serious adverse events(SAEs),as well as abnormal changes in clinical significance laboratory tests and other examinations
Measured: 4 years
MTD
Evaluate the Maximum tolerated dose
Measured: 12 months
RP2D
Evaluate the recommended dose for phase II
Measured: 12 months
Secondary outcomes (9)
Pharmacokinetic (PK) Parameter
The blood concentration of WJ01024
Measured: 1.5 years
SVR35
Percentage of subjects with spleen volume reduction of ≥35% (SVR35)
Measured: 4 years
Score in MPN-SAF-TSS
Percentage reduction in Total Symptom Score(TSS) and proportion of subjects achieving ≥50% reduction (TSS50) assessed by Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS)
Measured: 4 years
incidence and severity of adverse events and 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
Measured: 4 years
ORR：CR + PR + clinical improvement
Overall response rate (ORR, CR + PR + clinical improvement) as determined by the investigator according to IWG-MRT criteria
Measured: 4 years
LFS
Leukemia-free survival (LFS) as assessed by the investigator
Measured: 4 years
PFS
Progression free survival (PFS) as assessed by the investigator
Measured: 4 years
OS
OS
Measured: 4 years
LDH
Evaluation of changes in serum LDH levels
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start21 Nov 2023
- Primary completion26 Sep 2026 (estimated)
- Study completion21 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MF With SplenomegalyStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study consisted of two phases: Phase IA and Phase IB. Phase IA: Patients with myelofibrosis who have relapsed, are refractory or intolerant after treatment with JAK inhibitors Phase IB: Patients with intermediate- or high-risk myelofibrosis who have not previously received JAK inhibitor treatment
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, zhou, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802405
- Sponsor's protocol ID
- JS110-002-I（T）
- Status last verified
- Sep 2026
- First submitted
- 25 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study Evaluating the Safety and Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of Oral Administration of WJ01024 as a Monotherapy and in Combination With Ruxolitinib in Patients With Myelofibrosis
- ClinicalTrials.gov ID
- NCT07802405
- Acronym / sponsor ID
- JS110-002-I（T）
- Conditions
- MF With Splenomegaly
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 26 Sep 2026 (estimated)
- Study completion
- 21 Nov 2027 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I clinical study to evaluate the safety and tolerability, pharmacokinetic characteristics and preliminary efficacy of oral WJ01024 administered as monotherapy and in combination with ruxolitinib in patients with myelofibrosis（MF）. The study will be conducted in two phases: Phase IA and Phase IB.
Phase IA is a dose-escalation and dose-expansion study of WJ01024 monotherapy in patients with MF after failure of JAK inhibitor (JAKi) therapy (relapsed/refractory/intolerant). Phase IB is a dose-escalation and dose-expansion study of WJ01024 in combination with ruxolitinib in JAKi-naïve patients with intermediate- or high-risk MF.
Detailed description
Phase IA is a dose-escalation and dose-expansion study of WJ01024 monotherapy in patients with MF after failure of JAK inhibitor (JAKi) therapy (relapsed/refractory/intolerant).Dose escalation is carried out by combining accelerated titration and the traditional 3+3 design. During the accelerated titration phase, if no dose-limiting toxicity (DLT) and no ≥2 episodes of grade ≥2 treatment-related adverse events (TRAEs) occur within the first cycle (DLT observation period), no further subjects are enrolled at that dose level, and the study proceeds to the traditional 3+3 phase starting with the 60 mg group. At present, it is expected that the dose will be increased in four groups . If the researchers elects to explore intermediate doses or higher doses during the trial, adjustments will be made based on the actual situation. It is planned to expand the dosage by two groups. The final expanded dosage will be determined based on emerging safety and efficacy data. Dose escalation is stratified by background therapy (with vs. without background medication). Phase IB involves dose escalation and dose expansion studies of WJ01024 combined with ruxolitinib. Phase IB is planned to be conducted in JAKi-naïve patients with intermediate- or high-risk MF. Initiation of Phase IB requires that the group in Phase IA has completed the DLT observation period. Two combination dose groups are planned. Intermediate or higher doses may be explored at the investigator's discretion.Two combination dose levels are planned for expansion ;final expansion dose(s) will be determined based on emerging safety and efficacy data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study consisted of two phases: Phase IA and Phase IB. Phase IA: Patients with myelofibrosis who have relapsed, are refractory or intolerant after treatment with JAK inhibitors Phase IB: Patients with intermediate- or high-risk myelofibrosis who have not previously received JAK inhibitor treatment
| Arm | Type | Receives |
|---|---|---|
| WJ01024 tablet | Experimental | Drug: WJ01024 tablet |
Who may qualify
- Ages
- 18 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- The subjects voluntarily participated in this study after obtaining full informed consent and signed the informed consent form.
- Age ≥18 years old, gender not limited;
- Patients diagnosed with primary myelofibrosis (PMF) according to the 2016 World Health Organization (WHO) criteria, or patients diagnosed with post-essential thrombocythemia MF (PET-MF) or post-polycythemia vera MF (PPV-MF) according to International Working Group for Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria;
- Patients evaluated as intermediate-1, intermediate-2, or high-risk according to the International Prognostic System (DIPSS) scoring system;;
- Expected life expectancy is ≥ 24 weeks;
Key exclusion criteria (4 listed)
- Peripheral blood blasts >5% or Bone marrow blasts >10%.
- 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 strong CYP3A inhibitors or inducers within 14 days prior to initial administration"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WJ01024 tablet5-20mg BID (dosage per investigator judgement) | Drug | WJ01024 tablet |
Primary outcome
DLT
Time frame: 12 months
Incidence of DLT
AE
Time frame: 4 years
incidence and severity of adverse events(AEs) and serious adverse events(SAEs),as well as abnormal changes in clinical significance laboratory tests and other examinations
MTD
Time frame: 12 months
Evaluate the Maximum tolerated dose
RP2D
Time frame: 12 months
Evaluate the recommended dose for phase II
9 secondary outcomes
Pharmacokinetic (PK) Parameter
Time frame: 1.5 years
SVR35
Time frame: 4 years
Score in MPN-SAF-TSS
Time frame: 4 years
incidence and severity of adverse events and serious adverse events
Time frame: 4 years
ORR：CR + PR + clinical improvement
Time frame: 4 years
LFS
Time frame: 4 years
PFS
Time frame: 4 years
OS
Time frame: 4 years
LDH
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for MF With Splenomegaly
Active, not recruitingPhase 1/2
A Study to Evaluate Safety , Efficacy and Pharmacokinetics of WJ01024 Tablets Combined With Ruxolitinib in Patients With Myelofibrosis
Intermediate- and High-risk Myelofibrosis (MF) Patients With Splenomegaly
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing WJ01024 tablet in people with MF With Splenomegaly, run by Henan Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuai Guo (15902401702, sguo@wigenbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.