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MyelofibrosisPhase 1NCT06388759

TQ05105 Tablet for Myelofibrosis Treatment in Ruxolitinib-Resistant or Intolerant Patients

A Phase 1 study testing TQ05105 Tablets in people with Myelofibrosis, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 6 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is an open, single-arm, multi-center clinical study designed to evaluate the efficacy of TQ05105 Tablets in patients with intermediate-risk and high-risk myelofibrosis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myelofibrosis
What is being tested?
TQ05105 Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
6 sitesChina
Study dates
1 Aug 2022to 12 Aug 2025
Phase
Phase 1
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects voluntarily participated in this study, signed informed consent forms, and demonstrated good compliance；
  • Age: 18 or older (when signing the informed consent form); Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 2; Life expectancy ≥ 24 weeks;
  • Patients diagnosed with Primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (post-PV MF), or post essential thrombocythemia myelofibrosis (post-ET MF);
  • According to the dynamic international prognostic scoring system (DIPSS), patients with intermediate or high risk of bone marrow fibrosis were evaluated;
  • Patients with poor efficacy or intolerant of Ruxolitinib;
  • Spleen enlargement;
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  • Peripheral blood primary cells and bone marrow primary cells were ≤10%;
  • No growth factor, colony stimulating factor, thrombopoietin or platelet transfusion was received within 2 weeks before the examination, and the blood routine indexes met the requirements within 7 days before the first administration;
  • The Main organ function is normal;
  • Men and women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives, or condoms) during the study period and within 6 months after the end of the study. Serum human chorionic gonadotrophin（HCG）test is not negative within 7 days before the first administration and must be non-lactating patients.

Who cannot join

  • Patients who have previously received allogeneic stem cell transplantation, or received autologous stem cell transplantation within 3 months before the first administration, or recently planned stem cell transplantation;
  • Previous treatment with JAK inhibitors(except ruxolitinib);
  • Patients who have previously undergone splenectomy, or received splenic radiotherapy within 6 months before the first administration;
  • Other malignancies within 3 years prior to first administration or currently present;
  • Patients with multiple factors (such as inability to swallow, postoperative gastrointestinal resection, acute and chronic diarrhea, intestinal obstruction, etc.) affecting oral or absorption of drugs;
  • The non-hematological toxicity caused by previous treatment did not return to grade≤1;
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  • Major surgical treatment or significant traumatic injury within 4 weeks prior to first administration;
  • Presence of congenital bleeding disorder and congenital coagulopathy;
  • Patients who had arterial/venous thrombosis events within 6 months before the first administration;
  • Have a history of mental drug abuse, or have a mental disorder;
  • Active or uncontrolled severe infection;
  • Active hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection and HCV RNA positive;
  • Patients with ≥ grade 2 myocardial ischemia or myocardial infarction, arrhythmia, QT interval prolongation and ≥ grade 2 congestive heart failure;
  • Unsatisfactory blood pressure control despite standard therapy;
  • Patients with renal failure requiring hemodialysis or peritoneal dialysis;
  • Patients newly diagnosed with pulmonary interstitial fibrosis or drug-related interstitial lung disease within 3 months before the first administration;
  • Patients with a history of immunodeficiency disease or organ transplantation;
  • Patients with epilepsy requiring treatment;
  • Use of any MF medications, any immunomodulators, androgens, any immunosuppressive agents, erythropoietin, aspirin > 100 mg/day within 2 weeks prior to first administration;
  • Patients who have received Chinese patent medicines with anti-tumor indications specified in the approved drug package insert of China National Medical Products Administration (NMPA) within 2 weeks before the first administration;
  • Patients with uncontrolled pleural effusion, pericardial effusion or ascites;
  • There was a history of attenuated live vaccine inoculation within 4 weeks before the first administration, or attenuated live vaccine inoculation was planned during the study period;
  • People with known hypersensitivity to the study drug and excipients;
  • Patients diagnosed as active autoimmune diseases within 2 years before the first administration;
  • Those who participated in and used other anti-tumor clinical trial drugs within 4 weeks before the first administration;
  • According to the judgment of the investigators, some situations seriously endanger the safety of the subjects or affect the subjects to complete the study.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Anhui Provincial Hospital

    Hefei, Anhui, 230001

  • Shanghai Sixth People's Hospital

    Shanghai, Shanghai Municipality, 200233

  • Union Hospital Tongji College Huazhong University of Science And Technology

    Wuhan, Hubei, 430071

  • The First Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui, 241001

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000

Other trials in China

About this study

Official title: A Phase Ib Study of TQ05105 Tablets for the Treatment of Intermediate and High Risk Myelofibrosis Refractory/Relapsed/Intolerant to Ruxolitinib

This is an open, single-arm, multi-center clinical study designed to evaluate the efficacy of TQ05105 Tablets in patients with intermediate-risk and high-risk myelofibrosis.

Conditions
Myelofibrosis
Being tested
TQ05105 Tablets
Medical subject headings
Primary Myelofibrosis

What participants receive

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

  • TQ05105 TabletsDrug

    TQ05105 Tablets is a Janus kinase 1 (JAK1) and Janus kinase 2 （JAK2） Inhibitor

Study groups in NCT06388759
Study groupRoleWhat they receive
TQ05105 TabletsExperimentalTQ05105 Tablets，28 days as a treatment cycle.
Receives: Drug: TQ05105 Tablets

What is being measured

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

  1. Spleen volume reduction (SVR35)≥35% from baseline

    The proportion of subjects with spleen volume reduction ≥35%from baseline at the end of treatment at week 24.

    Measured: up to 24 weeks

Secondary outcomes (10)

  1. Optimum effective rate

    The proportion of subjects with at least one spleen volume measurement of ≥ 35% reduction against the baseline.

    Measured: up to 120 weeks

  2. Onset time of splenic response

    The time interval from the first administration to the date when the spleen volume was reduced by ≥ 35 % from the baseline.

    Measured: up to 120 weeks

  3. Duration of maintenance of spleen response (DoMSR) ≥35% reduction

    The time between the date when the spleen volume reduction ≥ 35% from baseline for the first time and the date when the spleen volume reduction < 35% from baseline.

    Measured: up to 120 weeks

  4. Myeloproliferative neoplasm- Symptom Assessment Form- Total Symptom Score (MPN-SAF TSS) : ≥ 50% Reduction from Baseline

    The proportion of subjects whose total symptom score on the Myeloproliferative Neoplasia Symptom Assessment Form-Total Symptom Score (MPN-SAF TSS) scale decreased by at least 50% compared to baseline. MPN-SAF-TSS is an effective tool for evaluating the disease burden in patients with myeloproliferative neoplasms. A higher score indicates more severe symptoms in patients. Each symptom is scored according to its severity, ranging from no symptoms (0 points) to the most severe (10 points), with a total of 10 levels. The sum of the scores for these 10 symptoms constitutes the MPN-SAF-TSS score.

    Measured: up to 24 weeks

  5. The total symptom score of MPN-SAF TSS decreased compared with baseline

    The total symptom score of MPN-SAF TSS decreased compared with baseline.

    Measured: up to 120 weeks

  6. Progression-free survival (PFS)

    The time interval from the first medication to the date of the occurrence of any of the following events, whichever occurs first: (1) Spleen volume increased by≥25% compared with the screening period ; (2) Death caused by any cause.

    Measured: up to 120 weeks

  7. Leukemia free survival (LFS)

    The time interval from the first medication to the occurrence of any of the following events, whichever comes first: ① The date on which the first bone marrow smear displays ≥20% blast cells; ② The first instance where the peripheral blood smear displays ≥20% blasts with an absolute blast count of ≥1×10^9/L, which persists for at least two weeks; ③ Death caused by any reason.

    Measured: up to 120 weeks

  8. Overall Survival (OS)

    OS is defined as the time from the first time the subject received treatment to death due to any cause.

    Measured: up to 120 weeks

  9. Incidence of adverse events (AEs)

    All adverse medical events that occur after the subject receives the investigational drug may be manifested as symptoms, signs, disease, or laboratory abnormalities, but are not necessarily causally related to the investigational drug, evaluated according to the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0).

    Measured: baseline up to 120 weeks

  10. Severity of AEs

    All adverse medical events that occur after the subject receives the investigational drug may be manifested as symptoms, signs, disease, or laboratory abnormalities, but are not necessarily causally related to the investigational drug, evaluated according to the CTCAE v5.0.

    Measured: baseline up to 120 weeks

Timeline

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

  1. First posted29 Apr 2024
  2. Study start1 Aug 2022
  3. Primary completion12 Aug 2025
  4. Study completion12 Aug 2025

Why it stopped: This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06388759
Sponsor's protocol ID
TQ05105-Ib-03
Status last verified
Aug 2025
First submitted
25 Apr 2024
Last updated
29 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hong M, Ding D, Zhang M, Gao S, Song L, Wu D, Lao S, Yu D, Chang C. A first-in-class JAK/ROCK inhibitor, Rovadicitinib in patients with myelofibrosis who were refractory or relapsed or intolerant to Ruxolitinib: A single-arm, multicenter, open-label, phase Ib study. Eur J Pharmacol. 2025 Oct 15;1005:178032. doi: 10.1016/j.ejphar.2025.178032. Epub 2025 Aug 5.

    PubMed 40752760

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TQ05105 Tablets in people with Myelofibrosis, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 6 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 10 inclusion and 26 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: stopped early, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 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?

The study was stopped early (reason given: This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Spleen volume reduction (SVR35)≥35% from baseline (time frame: up to 24 weeks). 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 NCT06388759, which also lists 1 linked publication.

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 29 Aug 2025.

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