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New hope for myelofibrosis patients: experimental drug TQ05105 enters phase 2 trial

NCT ID NCT07551427

Disease control Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times

Summary

This study tests an experimental drug, TQ05105, in 51 adults with intermediate or high-risk myelofibrosis, a serious bone marrow disease. The drug is for patients whose previous treatment (JAK inhibitors) stopped working or caused side effects. The main goal is to see if the drug can shrink an enlarged spleen by at least 35% after 24 weeks of treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 51 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Voluntary and signed informed consent, good compliance. 2. Age ≥18 years (at time of signing informed consent); Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2; life expectancy ≥24 weeks. 3. Diagnosis of primary myelofibrosis (PMF) per World Health Organization (WHO) 2016, or post-polycythemia vera myelofibrosis (post-PV-MF) or post-essential thrombocythemia myelofibrosis (post-ET-MF) per International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) criteria; Janus kinase 2 (JAK2) mutation status not restricted. 4. Intermediate or high risk per Dynamic International Prognostic Scoring System (DIPSS). 5. Cohort 1: Renal function classified as normal, mild impairment, or moderate impairment. Cohort 2: Prior Janus kinase (JAK) inhibitor therapy with refractory, relapsed, or intolerant. 6. Spleen enlargement (except Cohort 1). 7. Peripheral blood and bone marrow blasts ≤10%. 8. No growth factors, colony-stimulating factors, thrombopoietin, or platelet transfusion within 2 weeks before first dose; and routine blood parameters meet requirements within 7 days before first dose. 9. Adequate major organ function within 7 days before first dose per protocol (renal function not restricted for Cohort 1). 10. Agreement to use effective contraception during the study and for 6 months after; negative pregnancy test for females of childbearing potential; non-lactating. Exclusion Criteria: 1. Prior allogeneic stem cell transplantation, or autologous stem cell transplantation within 3 months before first dose, or planned stem cell transplantation. 2. Prior treatment with 2 or more Janus kinase (JAK) inhibitors (except Cohort 1). 3. Prior splenectomy or splenic radiotherapy within 6 months before first dose. 4. Other malignancies within 3 years before first dose or currently present (exceptions per protocol). 5. Factors affecting oral drug absorption. 6. Non-hematologic toxicity from prior therapy not recovered to ≤ grade 1 (excluding hypertension and alopecia). 7. Major surgery or significant traumatic injury within 4 weeks before first dose. 8. Congenital bleeding or coagulation disorders. 9. Arterial/venous thrombosis event within 6 months before first dose. 10. History of substance abuse or mental disorder. 11. Active or uncontrolled severe infection. 12. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. 13. Grade ≥2 myocardial ischemia or infarction, arrhythmia, QT prolongation, or grade ≥2 congestive heart failure. 14. Uncontrolled hypertension despite standard therapy. 15. Renal failure requiring hemodialysis or peritoneal dialysis. 16. Newly diagnosed pulmonary interstitial fibrosis or drug-related interstitial lung disease within 3 months before first dose. 17. History of immunodeficiency or organ transplantation. 18. Epilepsy requiring treatment. 19. Use of protocol-prohibited myelofibrosis (MF) medications, immunomodulators, or immunosuppressants within specified time before first dose. 20. Use of Chinese patent medicines with anti-tumor indications approved by National Medical Products Administration (NMPA) within 2 weeks before first dose. 21. Uncontrolled pleural effusion, pericardial effusion, or ascites. 22. Live attenuated vaccine within 4 weeks before first dose or planned during the study. 23. Known hypersensitivity to study drug or excipients. 24. Diagnosis of active autoimmune disease within 2 years before first dose. 25. Participation in another interventional clinical trial with investigational drug within 4 weeks before first dose. 26. Any condition that, in the investigator's judgment, seriously endangers subject safety or interferes with study completion.

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Conditions

The condition(s) this trial relates to.

myelofibrosis primary myelofibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myelofibrosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    24 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Hospital of Chengde Medical College

    RECRUITING

    Chengde, Hebei, 067000, China

  • Cangzhou People's Hospital rovince

    RECRUITING

    Cangzhou, Hebei, 061014, China

  • Chinese Academy of Medical Sciences Hematology Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 301617, China

  • Fujian Medical University Union Hospital

    RECRUITING

    Fuzhou, Fujian, 350001, China

  • Guangzhou First Municipal People's Hospital

    RECRUITING

    Guangzhou, Guangdong, 510180, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, 450000, China

  • Heping Hospital Affiliated To Changzhi Medical College

    RECRUITING

    Changzhi, Shanxi, 046000, China

  • Jiangsu Provincial Hospital of Traditional Chinese Medicine

    RECRUITING

    Nanjing, Jiangsu, 210029, China

  • Nanjing Drum Tower Hospital

    RECRUITING

    Nanjin, Jiangsu, 210000, China

  • Shanghai Sixth People's Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200233, China

  • Shengjing Hospital Affiliated to China Medical University

    RECRUITING

    Shenyang, Liaoning, 110000, China

  • Sichuan Provincial People's Hospital

    RECRUITING

    Chengdu, Sichuan, 610000, China

  • The First Affiliated Hospital of Air Force Medical University

    RECRUITING

    Xi'an, Shaanxi, 710000, China

  • The First Affiliated Hospital of Guangxi Medical University

    RECRUITING

    Nanning, Guangxi, 530000, China

  • The First Affiliated Hospital of University of Science and Technology of China

    RECRUITING

    Hefei, Anhui, 230001, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Xi'an, Shaanxi, 710000, China

  • The First Affiliated Hospital of Xinjiang Medical University

    RECRUITING

    Ürümqi, Xinjiang, 830011, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

  • The First Hospital of Jilin University

    RECRUITING

    Changchun, Jilin, 130021, China

  • The Second Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, 050000, China

  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

    RECRUITING

    Wuhan, Hubei, 430071, China

  • Union Hospital Tongji College Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430071, China

  • Xingtai People's Hospital

    RECRUITING

    Xingtai, Hebei, 054000, China

  • Zhuzhou Central Hospital

    RECRUITING

    Zhuzhou, Hunan, 412000, China

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