ClinicalTrials.gg
RecruitingNCT07443306Updated Aug 13, 2026

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 interventional study of Flonoltinib Maleate in MF, sponsored by Chengdu Zenitar Biomedical Technology Co., Ltd. Recruiting at 2 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Chengdu Zenitar Biomedical Technology Co., Ltd · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
64
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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 . 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.

02

Conditions studied

  • MF
03

In context

Lead sponsor

Chengdu Zenitar Biomedical Technology Co., Ltd is the lead sponsor of 23 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age range of 18-80 years old (including threshold), gender not limited;
  2. 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;
  3. 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;
  4. MF patients who have received JAK inhibitor treatment in the past and meet the criteria of /recurrent/intolerant;
  5. Expected survival period greater than 24 weeks;
  6. score 0-2 points;
  7. 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;
  8. Peripheral blood and bone marrow blasts \<=10%;
  9. Within 7 days prior to randomization, >=1.0 × 10\^9/L, count >=100 × 10\^9/L, HGB>60 g/L ;
  10. Within 7 days prior to randomization, the main organ functions were generally normal, meeting the following criteria: and AST \<= 2.5 × ; \<=2.0×ULN; Serum creatinine \<=1.5 × ULN or serum rate (Ccr)>50 mL/min; , PT, and APTT \<= 1.5 × ULN;
  11. Can understand and voluntarily sign an form..

Exclusion criteria

Exclusion Criteria:

  1. 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);
  2. Allergy to experimental drugs and their ;
  3. 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;
  4. Patients with a history of congestive heart failure ( grade III or above), unstable angina or myocardial infarction, cerebrovascular accidents or thromboembolism within the first 6 months of screening;
  5. Individuals with impaired cardiac function (those with \<45% detected by echocardiography, congenital ventricular arrhythmia, >450 ms on (males), QTcF>470 ms on electrocardiogram (females), or those with arrhythmia requiring treatment at the time of screening);
  6. Patients with congenital or acquired bleeding disorders or unstable thrombotic diseases requiring anticoagulant therapy;
  7. Any active infections requiring systemic treatment (oral, intravenous, subcutaneous, intramuscular, etc.) within 14 days prior to enrollment;
  8. 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);
  9. 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;
  10. Active infection of virus (HBV) or 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 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;
  11. Patients who are positive for antibodies (HIV Ab) or anti Treponema pallidum antibodies (TP Ab) (Treponema pallidum antibodies positive);
  12. Patients with epilepsy or those taking psychotropic or sedative drugs during screening;
  13. Pregnant or lactating female patients, female/male patients with fertility who refuse to use measures during the trial period and within 6 months after the trial ends;
  14. 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);
  15. Patients with swallowing difficulties, chronic diarrhea, or oral absorption disorders;
  16. Combining other serious illnesses, researchers believe may affect patient safety or compliance;
  17. 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;
  18. Select patients who have used JAK inhibitors within the previous 4 weeks or 5 half lives (whichever is longer);
  19. 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 , prednisone>10 mg/day or with the same biological effect intensity within 2 weeks or 5 half-life periods (whichever is the elder) before screening;
  20. Researchers believe that there are other factors that are not suitable for participating in the experiment.
Terms in these criteria, in plain language(21)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
64 participants (estimated)

Study arms

  • Experimental
    Flonoltinib maleate

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

    Drug: Flonoltinib Maleate

Interventions

  • DrugFlonoltinib Maleate

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

06

What researchers measure

Primary outcomes

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

    Time frame: Week 24

Secondary outcomes

  1. Spleen response time

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

    Time frame: 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.

    Time frame: 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

    Time frame: Week 2,week 4,week 8,week 12,week 24

07

Study locations

2 of 2 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07443306
Responsible party
Sponsor
First posted
Mar 2, 2026
Start date
Mar 18, 2026
Primary completion
Dec 30, 2027 (estimated)
Completion
Mar 30, 2028 (estimated)
Last update
Aug 13, 2026

Study contacts

Wang Fangmei
Contact
fangmei.wang@zenitar.cn
13808086495
Sun Liangkun
Contact
liangkunsun@zenitar.cn
Xiao Zhijian
principal investigator · Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS)
Niu Ting
principal investigator · West China Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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