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A Clinical Trial of TQ05105 Tablets Combined With TQB3617 Capsules in the Treatment of Myelofibrosis (MF)

Study Purpose

This is an open, single-arm, multi-center clinical study designed to evaluate the efficacy and safety of TQ05105 Tablets combined with TQB3617 Capsules in patients with intermediate- and high-risk Myelofibrosis.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.
  • - Patients with poor efficacy of JAK inhibitors (for phase Ib and phase II cohort 2) - 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; - Patients who have previously undergone splenectomy, or received splenic radiotherapy within 6 months before the first administration; - Use of any MF medications, any immunomodulators, androgens, any immunosuppressive agents, erythropoietin, aspirin > 100 mg/day within 2 weeks prior to 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; - 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06122831
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Myelofibrosis
Arms & Interventions

Arms

Experimental: TQ05105 Tablets + TQB3617 Capsules

TQ05105 Tablets combined with TQB3617 Capsules, orally administered. 21 days as a treatment cycle.

Interventions

Drug: - TQ05105 Tablets

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

Drug: - TQB3617 Capsules

TQB3617 Capsules is a Bromodomain and Extra-Terminal (BET) Inhibitor

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China

Status

Not yet recruiting

Address

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 525000

Site Contact

Jianyu Weng, Doctor

[email protected]

13924197172

Nanning, Guangxi, China

Status

Not yet recruiting

Address

Guangxi Zhuang Autonomous Region People's Hospital

Nanning, Guangxi, 530016

Site Contact

Mei Lan, Master

[email protected]

13377131268

Cangzhou People's Hosipital, Cangzhou, Hebei, China

Status

Not yet recruiting

Address

Cangzhou People's Hosipital

Cangzhou, Hebei, 061014

Site Contact

Hongmei Ma, Master

[email protected]

18031798229

Chengde, Hebei, China

Status

Not yet recruiting

Address

Affiliated Hospital of Chengde Medical College

Chengde, Hebei, 067020

Site Contact

Zhihua Zhang, Master

[email protected]

15633142905

Tangshan, Hebei, China

Status

Not yet recruiting

Address

North China of Science and Technology University Affiliated Hospital

Tangshan, Hebei, 063000

Site Contact

Zhenyu Yan, Doctor

[email protected]

18831508262

Xingtai People's Hospital, Xingtai, Hebei, China

Status

Not yet recruiting

Address

Xingtai People's Hospital

Xingtai, Hebei, 054031

Site Contact

Zongjiu Jiao, Master

[email protected]

18631921299

The First Hospital of Harbin, Harbin, Heilongjiang, China

Status

Not yet recruiting

Address

The First Hospital of Harbin

Harbin, Heilongjiang, 150010

Site Contact

Tiejun Gong, Master

[email protected]

13836027737

Henan Cancer Hospital, Zhengzhou, Henan, China

Status

Not yet recruiting

Address

Henan Cancer Hospital

Zhengzhou, Henan, 450003

Site Contact

Hu Zhou, Doctor

[email protected]

13939068863

Wuhan, Hubei, China

Status

Not yet recruiting

Address

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

Wuhan, Hubei, 430071

Site Contact

Zhenya Hong, Doctor

[email protected]

13476158466

Wuhan, Hubei, China

Status

Not yet recruiting

Address

Union Hospital Tongji College Huazhong Unizersity of Science And Technology

Wuhan, Hubei, 430071

Site Contact

Min Zhang, Doctor

[email protected]

15871818568

Wuhan University Zhongnan Hospital, Wuhan, Hubei, China

Status

Not yet recruiting

Address

Wuhan University Zhongnan Hospital

Wuhan, Hubei, 430071

Site Contact

Xuelan Zuo, Doctor

[email protected]

13627237916

Hohhot, Inner Mongolia, China

Status

Not yet recruiting

Address

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, 010000

Site Contact

Da Gao, Master

[email protected]

13947130473

The Public Hospital of Wuxi, Wuxi, Jiangsu, China

Status

Not yet recruiting

Address

The Public Hospital of Wuxi

Wuxi, Jiangsu, 214000

Site Contact

Xin Zhou, Bachelor

[email protected]

13358111962

The First Hospital of Jilin University, Changchun, Jilin, China

Status

Not yet recruiting

Address

The First Hospital of Jilin University

Changchun, Jilin, 130021

Site Contact

Sujun Gao, Doctor

[email protected]

15843073208

Xi'an, Shaanxi, China

Status

Not yet recruiting

Address

Xi 'An Jiaotong University Second Affiliated Hospital

Xi'an, Shaanxi, 710000

Site Contact

Aili He, Doctor

[email protected]

13891939962

Shanghai, Shanghai, China

Status

Recruiting

Address

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai, 200000

Site Contact

Wen Wu, Master

[email protected]

13611770009

Shanghai Sixth People's Hospital, Shanghai, Shanghai, China

Status

Recruiting

Address

Shanghai Sixth People's Hospital

Shanghai, Shanghai, 200233

Site Contact

Chunkang Chang, Doctor

[email protected]

13764643870

Changzhi, Shanxi, China

Status

Not yet recruiting

Address

Heping Hospital Affiliated to Changzhi Medical College

Changzhi, Shanxi, 046000

Site Contact

Xuliang Shen, Doctor

[email protected]

13015365546

People's Hospital of Tianjin City, Tianjin, Tianjin, China

Status

Not yet recruiting

Address

People's Hospital of Tianjin City

Tianjin, Tianjin, 300122

Site Contact

Xingli Zhao, Doctor

[email protected]

13752255454

Ürümqi, Xinjiang, China

Status

Not yet recruiting

Address

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830011

Site Contact

Jianping Hao, Master

[email protected]

13579876416