Treatment of Myelofibrosis with TQ05105 and TQB3617

A Phase Ib/II Clinical Trial of TQ05105 Tablets Combined With TQB3617 Capsules in the Treatment of Intermediate- and High-risk Myelofibrosis

This study is testing a new combination of TQ05105 tablets and TQB3617 capsules to see if it can help people with intermediate- and high-risk Myelofibrosis feel better.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 92 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Locations: 22 sites (Guangzhou, Guangdong and 21 other locations)
• Trial ID: NCT06122831 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of TQ05105 Tablets combined with TQB3617 Capsules in patients suffering from intermediate- and high-risk Myelofibrosis. It is an open-label, single-arm, multi-center study that aims to provide insights into the potential benefits of this combination therapy. Eligible participants include those diagnosed with various forms of Myelofibrosis who meet specific criteria regarding their health status and previous treatments. The study will assess the impact of the treatment on symptoms and overall patient outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with intermediate- or high-risk Myelofibrosis who have not responded well to previous JAK inhibitor treatments.

Not a fit: Patients with low-risk Myelofibrosis or those who have not been diagnosed with the condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of Myelofibrosis and enhance the quality of life for patients.

How similar studies have performed: While there have been studies on Myelofibrosis treatments, the specific combination of TQ05105 and TQB3617 is novel and has not been extensively tested in prior research.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Guangdong and 21 other locations

• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Guangxi Zhuang Autonomous Region People's Hospital — Nanning, Guangxi, China (Not_yet_recruiting)
• Cangzhou People's Hosipital — Cangzhou, Hebei, China (Not_yet_recruiting)
• Affiliated Hospital of Chengde Medical College — Chengde, Hebei, China (Not_yet_recruiting)
• North China of Science and Technology University Affiliated Hospital — Tangshan, Hebei, China (Not_yet_recruiting)
• Xingtai People's Hospital — Xingtai, Hebei, China (Not_yet_recruiting)
• The First Hospital of Harbin — Harbin, Heilongjiang, China (Not_yet_recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology — Wuhan, Hubei, China (Not_yet_recruiting)
• Union Hospital Tongji College Huazhong Unizersity of Science And Technology — Wuhan, Hubei, China (Not_yet_recruiting)
• Wuhan University Zhongnan Hospital — Wuhan, Hubei, China (Not_yet_recruiting)
• The Affiliated Hospital of Inner Mongolia Medical University — Hohhot, Inner Mongolia, China (Not_yet_recruiting)
• The Public Hospital of Wuxi — Wuxi, Jiangsu, China (Not_yet_recruiting)
• The First Hospital of Jilin University — Changchun, Jilin, China (Not_yet_recruiting)
• Xi 'An Jiaotong University Second Affiliated Hospital — Xi'an, Shaanxi, China (Not_yet_recruiting)
• Tai'an City Central Hospital — Tai’an, Shandong, China (Not_yet_recruiting)
• Central Hospital Of Minhang District, Shanghai — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
• Shanghai Sixth People's Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• Heping Hospital Affiliated to Changzhi Medical College — Changzhi, Shanxi, China (Not_yet_recruiting)
• People's Hospital of Tianjin City — Tianjin, Tianjin Municipality, China (Not_yet_recruiting)
• The First Affiliated Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Chunkang Chang, Doctor

Conditions Myelofibrosis