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MFPhase 2NCT07443306

A Clinical Trial of Flonoltinib Maleate Tablets in the Treatment of JAK Inhibitor Refractory/Relapsed/Intolerant Patients With Intermediate to High Risk Myelofibrosis

A Phase 2 study testing Flonoltinib Maleate in people with MF, run by Chengdu Zenitar Biomedical Technology Co., Ltd at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This trial adopts a single arm, open label, multi center clinical trial design, with a planned enrollment of approximately 64 participants in the intermediate to high risk MF trial who are refractory, relapsed, or intolerant to JAK inhibitor . Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
MF
What is being tested?
Flonoltinib Maleate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
2 sitesChina
Study dates
18 Mar 2026to 30 Mar 2028
Phase
Phase 2
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age range of 18-80 years old (including threshold), gender not limited;
  • Patients diagnosed with primary myelofibrosis (PMF) according to WHO criteria (2016 edition) or patients diagnosed with post polycythemia vera myelofibrosis (PPV-MF) or post thrombocytopenia myelofibrosis (PET-MF) according to IWG-MRT criteria;
  • Patients with myelofibrosis assessed as intermediate-2 or high-risk according to the dynamic international prognostic scoring system (DIPSS) prognostic classification criteria;or patients with intermediate-1 myelofibrosis who exhibit hepatosplenomegaly and require treatment;
  • MF patients who have received JAK inhibitor treatment in the past and meet the criteria of refractory/recurrent/intolerant;
  • Expected survival period greater than 24 weeks;
  • ECOG score 0-2 points;
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  • Splenomegaly: Palpation of the splenic margin reaching or exceeding 5cm below the rib (distance from the intersection of the left clavicle midline and left rib margin to the farthest point of the spleen); Or due to physical reasons (such as obesity), it may not be palpable, but MRI/CT spleen evaluation during screening confirms a volume of >= 450 cm^3;
  • Peripheral blood and bone marrow blasts <=10%;
  • Within 7 days prior to randomization, ANC >=1.0 × 10^9/L, platelet count >=100 × 10^9/L, HGB>60 g/L ;
  • Within 7 days prior to randomization, the main organ functions were generally normal, meeting the following criteria: ALT and AST <= 2.5 × ULN; TBIL<=2.0×ULN; Serum creatinine <=1.5 × ULN or serum creatinine clearance rate (Ccr)>50 mL/min; INR, PT, and APTT <= 1.5 × ULN;
  • Can understand and voluntarily sign an informed consent form..

Who cannot join

  • The toxic reactions of previous anti-cancer treatments have not recovered to grade 1 or below (excluding hair loss), or have not fully recovered from previous surgeries(such as undergoing major surgery within 4 weeks);
  • Allergy to experimental drugs and their excipients;
  • For any significant clinical and laboratory abnormalities, the researchers believe that they affect the safety evaluators, such as: a. uncontrollable diabetes - fasting blood glucose>250 mg/dL (13.9 mmol/L), b. hypertension and cannot be reduced to the following range after treatment with two or more antihypertensive drugs (systolic blood pressure<160 mmHg, diastolic blood pressure<100 mmHg), c. peripheral neuropathy;
  • Patients with a history of congestive heart failure (NYHA grade III or above), unstable angina or myocardial infarction, cerebrovascular accidents or thromboembolism within the first 6 months of screening;
  • Individuals with impaired cardiac function (those with ejection fraction<45% detected by echocardiography, congenital ventricular arrhythmia, QTcF>450 ms on electrocardiogram (males), QTcF>470 ms on electrocardiogram (females), or those with arrhythmia requiring treatment at the time of screening);
  • Patients with congenital or acquired bleeding disorders or unstable thrombotic diseases requiring anticoagulant therapy;
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  • Any active infections requiring systemic treatment (oral, intravenous, subcutaneous, intramuscular, etc.) within 14 days prior to enrollment;
  • Individuals who have experienced active tuberculosis infection within the 48 weeks prior to screening or those who have been diagnosed with latent tuberculosis infection during the screening period (those diagnosed with latent tuberculosis infection must complete preventive anti tuberculosis treatment for at least 3 months before they can be enrolled);
  • Patients who have undergone splenectomy in the past or those who have received splenic radiation therapy within the 12 months prior to their first dose;
  • Active infection of hepatitis B virus (HBV) or hepatitis C virus (HCV), except for the following patients: a) HBV infection: patients who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and undergo peripheral blood HBV-DNA testing, with the lower limit of HBV-DNA detection value (i.e. the upper limit of normal value in the laboratory of each research center) can be enrolled; If the baseline HBsAg is positive, continuous antiviral treatment is required after enrollment, and HBV-DNA testing should be conducted every 12 weeks and at EOT visits; b) Patients who are positive for HCV serology but negative for HCV-RNA can be included in the study;
  • Patients who are positive for human immunodeficiency virus antibodies (HIV Ab) or anti Treponema pallidum antibodies (TP Ab) (Treponema pallidum antibodies positive);
  • Patients with epilepsy or those taking psychotropic or sedative drugs during screening;
  • Pregnant or lactating female patients, female/male patients with fertility who refuse to use contraceptive measures during the trial period and within 6 months after the trial ends;
  • Patients who have suffered from other malignant tumors within the past 5 years before the first administration (excluding cured carcinoma in situ and basal cell carcinoma of the skin);
  • Patients with swallowing difficulties, chronic diarrhea, or oral absorption disorders;
  • Combining other serious illnesses, researchers believe may affect patient safety or compliance;
  • Patients who have participated in clinical trials of other new drugs or medical devices within one month before the first administration and have taken the study drug or used the study device;
  • Select patients who have used JAK inhibitors within the previous 4 weeks or 5 half lives (whichever is longer);
  • Patients who have used any MF drug (including traditional Chinese patent medicines and simple preparations with anti-tumor indications), androgen, any immunomodulator (such as thalidomide), any immunosuppressant, prednisone>10 mg/day or glucocorticoid with the same biological effect intensity within 2 weeks or 5 half-life periods (whichever is the elder) before screening;
  • Researchers believe that there are other factors that are not suitable for participating in the experiment.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Wang Fangmei contact

13808086495

fangmei.wang@zenitar.cn

Sun Liangkun contact

liangkunsun@zenitar.cn

China2 sites, 2 recruiting

  • West China Hospital Sichuan University

    Chengdu, Sichuan

    Ting Niu, Doctor, 02885423237, huaxilunli@wchscu.cn

    Recruiting

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS)

    Tianjin, Tianjin Municipality

    Qirou Wang, 022-23909095, ec@ihcams.ac.cn

    Recruiting

Other trials in China

About this study

Official title: Flonoltinib Maleate for the Treatment of Patients With Intermediate- or High-risk Myelofibrosis Who Are Refractory, Relapsed, or Intolerant to JAK Inhibitors: a Single-arm, Open-label, Multicenter Phase IIb Clinical Trial

This trial adopts a single arm, open label, multi center clinical trial design, with a planned enrollment of approximately 64 participants in the intermediate to high risk MF trial who are refractory, relapsed, or intolerant to JAK inhibitor . Select successful trial participants and allocate flonoltinib maleate tablets based on platelet count levels during the screening period, qd,Oral administration on an empty stomach until the participants meet the withdrawal criteria.

Conditions
MF
Being tested
Flonoltinib Maleate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Flonoltinib MaleateDrug

    Allocate flonoltinib maleate tablets 50mg or 75mg once daily on an empty stomach based on platelet count levels during the screening period

Study groups in NCT07443306
Study groupRoleWhat they receive
Flonoltinib maleateExperimentalAllocate 50mg or 75mg flonoltinib maleate tablets once daily on an empty stomach based on platelet count levels during the screening period
Receives: Drug: Flonoltinib Maleate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of subjects with >=35% reduction in spleen volume from baseline

    Measured: Week 24

Secondary outcomes (3)

  1. Spleen response time

    The time when the spleen volume is first observed to decrease by >=35% from baseline

    Measured: Week 12,week 24

  2. MPN-SAF TSS Total Symptom Score and Baseline Comparison Decrease

    The MPN-SAF-TSS is used to assess the symptom burden of patients with myeloproliferative neoplasms. The questionnaire also reflects the quality of life of patients to a certain extent. During the diagnosis and treatment process, the MPN-10 questionnaire includes 10 sub symptoms (fatigue, early satiety, abdominal discomfort, poor activity, lack of concentration, night sweats, skin itching, bone pain, fever, and weight loss). Each item is graded from 0 (none) to 10 (heaviest), with a total score of 0-100 points. The higher the total score, the heavier the symptom burden.

    Measured: Week 2,week 4,week 8,week 12,week 24

  3. Overall survival period

    The time interval between the first use of medication and death caused by any reason

    Measured: Week 2,week 4,week 8,week 12,week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2026
  2. Study start18 Mar 2026
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion30 Mar 2028 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07443306
Sponsor's protocol ID
FMF-04
Status last verified
Apr 2026
First submitted
19 Dec 2025
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Flonoltinib Maleate in people with MF, run by Chengdu Zenitar Biomedical Technology Co., Ltd at 2 sites 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 11 inclusion and 20 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 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Wang Fangmei (13808086495, fangmei.wang@zenitar.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of subjects with >=35% reduction in spleen volume from baseline (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07443306.

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 13 Aug 2026.

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