New drug duo aims to shrink enlarged spleens in myelofibrosis patients

NCT ID NCT06122831

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

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether combining two experimental drugs (TQ05105 and TQB3617) can safely shrink the spleen and improve symptoms in people with intermediate- or high-risk myelofibrosis, a type of bone marrow cancer. About 92 adults will take the pills daily, and researchers will monitor spleen size and side effects. The goal is to control the disease, not cure it.

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Study facts

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

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 92 people

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

Started

Dec 2023

Expected to finish

Apr 2027

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: * Voluntary and signed informed consent, good compliance. * Age: 18 or above (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. * Within 7 days before the first administration, the symptom score of myeloproliferative neoplasms should meet certain requirements. * Patients with poor efficacy of JAK inhibitors (for phase Ib and phase II cohort 2, cohort 3) * Patients who had not received JAK inhibitor treatment (for phase II cohort 1). * Spleen enlargement. * 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. Exclusion Criteria: * 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 BET inhibitors combined with JAK inhibitor; * Patients who have previously undergone splenectomy, or received splenic radiotherapy within 6 months before the first administration; * Use of any MF medications, any immunomodulators, any immunosuppressive agents, within 2 weeks prior to first administration (There are separate withdrawal requirements for hydroxyurea, JAK inhibitors, androgen drugs, erythropoietin, long-acting recombinant interferon-α, etc.); * 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; * 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, or active Corona Virus Disease 2019 (COVID-19) infection; * Patients with grade III or above congestive heart failure, unstable angina pectoris or myocardial infarction, or arrhythmia requiring treatment, or QT interval prolongation within 6 months before the first administration; * 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; * 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 (except JAK inhibitor-related clinical trials). * According to the judgment of the investigators, some situations seriously endanger the safety of the subjects or affect the subjects to complete the study.

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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.

The places running it

22 sites. The list below names each one and where it is.
The official record

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

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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
NOT_YET_RECRUITING

Chengde, Hebei, 067020, China
Cangzhou People's Hosipital
NOT_YET_RECRUITING

Cangzhou, Hebei, 061014, China
Central Hospital Of Minhang District, Shanghai
NOT_YET_RECRUITING

Shanghai, Shanghai Municipality, 200000, China
Guangdong Provincial People's Hospital
NOT_YET_RECRUITING

Guangzhou, Guangdong, 525000, China
Guangxi Zhuang Autonomous Region People's Hospital
NOT_YET_RECRUITING

Nanning, Guangxi, 530016, China
Henan Cancer Hospital
NOT_YET_RECRUITING

Zhengzhou, Henan, 450003, China
Heping Hospital Affiliated to Changzhi Medical College
NOT_YET_RECRUITING

Changzhi, Shanxi, 046000, China
North China of Science and Technology University Affiliated Hospital
NOT_YET_RECRUITING

Tangshan, Hebei, 063000, China
People's Hospital of Tianjin City
NOT_YET_RECRUITING

Tianjin, Tianjin Municipality, 300122, China
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
RECRUITING

Shanghai, Shanghai Municipality, 200000, China
Shanghai Sixth People's Hospital
RECRUITING

Shanghai, Shanghai Municipality, 200233, China
Tai'an City Central Hospital
NOT_YET_RECRUITING

Tai’an, Shandong, 271099, China
The Affiliated Hospital of Inner Mongolia Medical University
NOT_YET_RECRUITING

Hohhot, Inner Mongolia, 010000, China
The First Affiliated Hospital of Xinjiang Medical University
NOT_YET_RECRUITING

Ürümqi, Xinjiang, 830011, China
The First Hospital of Harbin
NOT_YET_RECRUITING

Harbin, Heilongjiang, 150010, China
The First Hospital of Jilin University
NOT_YET_RECRUITING

Changchun, Jilin, 130021, China
The Public Hospital of Wuxi
NOT_YET_RECRUITING

Wuxi, Jiangsu, 214000, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
NOT_YET_RECRUITING

Wuhan, Hubei, 430071, China
Union Hospital Tongji College Huazhong Unizersity of Science And Technology
NOT_YET_RECRUITING

Wuhan, Hubei, 430071, China
Wuhan University Zhongnan Hospital
NOT_YET_RECRUITING

Wuhan, Hubei, 430071, China
Xi 'An Jiaotong University Second Affiliated Hospital
NOT_YET_RECRUITING

Xi'an, Shaanxi, 710000, China
Xingtai People's Hospital
NOT_YET_RECRUITING

Xingtai, Hebei, 054031, China

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