TQB3909 Tablets in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (MCL)
NCT ID: NCT06106841
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
19 participants
INTERVENTIONAL
2023-10-05
2024-10-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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400mg of TQB3909 tablets
tablet, 28 days as a treatment cycle.
400mg of TQB3909 tablets
TQB3909 tablets 400mg, TQB3909 tablets is a B-cell lymphoma (BCL)-2 inhibitor.
600mg of TQB3909 tablets
tablet, 28 days as a treatment cycle.
600mg of TQB3909 tablets
TQB3909 tablets 600mg, TQB3909 tablets is a B-cell lymphoma (BCL)-2 inhibitor.
Interventions
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400mg of TQB3909 tablets
TQB3909 tablets 400mg, TQB3909 tablets is a B-cell lymphoma (BCL)-2 inhibitor.
600mg of TQB3909 tablets
TQB3909 tablets 600mg, TQB3909 tablets is a B-cell lymphoma (BCL)-2 inhibitor.
Eligibility Criteria
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Inclusion Criteria
* Age: ≥ 18 years old (when signing the informed consent form); Eastern Cooperative Oncology Group performance status (ECOG PS) score: 0-2 points; Expected survival is more than 3 months;
* Subject population: Confirmed as MCL by local laboratory pathology and independent pathology review (stage 2).
* The main organs are functioning well,
* The patient's Computed Tomography (CT) / Magnetic Resonance Imaging (MRI) shows measurable lesions, defined as ≥ 1 lymph node with the longest diameter of \> 1.5 cm or ≥ 1 extranodal lesion with the longest diameter of \> 1.0 cm, which can be measured by ≥ 2 vertical dimensions;
* Female subjects of childbearing age should agree to use contraception (e.g., pills, or condoms) during the study and for 6 months after the end of the study; Have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; Male participants should agree that contraception must be used during the study period and for 6 months after the end of the study period.
* Significant surgical treatment and obvious traumatic injury within 28 days prior to the start of study treatment;
* Arteriovenous thrombotic events within 3 months before the first dose, such as cerebrovascular accident (including cerebral hemorrhage, cerebral infarction, except lacunar cerebral infarction), deep vein thrombosis (except secondary to deep vein catheterization) and pulmonary embolism;
* Those who have a history of psychotropic substance abuse and cannot be withdrawn or have mental disorders;
* Subjects with any severe and/or uncontrolled medical conditions, including:
* Grade ≥2 myocardial ischemia or myocardial infarction, arrhythmia (Quick Time Constant Fluctuation (QTcF) \>450 ms in men, QTcF \>470 ms in women) and grade ≥2 congestive heart failure (New York Heart Association (NYHA) grade), cardiac ultrasound assessment of left ventricular ejection fraction (LVEF) of \<50%; poorly controlled hypertension, defined as systolic blood pressure \> 170 mmHg and diastolic blood pressure \> 105 mmHg at least 2 consecutive blood pressure measurements at the time of screening；
* presence of active infection (≥ CTCAE grade 2 infection);
* active hepatitis; Hepatitis B virus (HBV) infection, HBV DNA positive or copy number exceeding the upper limit of normal values in the research center;
* Have a history of immunodeficiency, including Human Immunodeficiency Virus(HIV)-positive or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;
* Those who have epilepsy and need treatment.
* Have received chemotherapy and radiotherapy within 4 weeks before the first dose, received immune checkpoint inhibitors and Chimeric Antigen Receptor T-Cell Immunotherapy (CAR-T) therapy 12 weeks before the first dose, and received other small molecule antitumor therapy (elution period from the end of the last treatment) before the first drug use within 5 half-lives;
* Previous treatment with BCL-2 inhibitors;
* Have received a live vaccine within 4 weeks prior to the first dose, or plan to be vaccinated during the study;
* Have participated in other antitumor drug clinical trials within 4 weeks before the first dose;
* According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of subjects or affect the completion of the study, or subjects who are considered to be unsuitable for enrollment for other reasons.
* Allergic to allopurinol and benzbromarone.
Exclusion Criteria
* It is known that lymphoma affects the central nervous system (CNS);
* Previous allogeneic hematopoietic stem cell transplantation;
* Have received autologous hematopoietic stem cell transplantation within 3 months before the first dose of study drug;
* There are a variety of factors that affect oral drugs (such as inability to swallow, chronic diarrhea and intestinal obstruction, inflammatory bowel disease, malabsorption syndrome, etc.);
18 Years
ALL
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Peking University Third Hospital
Beijing, Beijing Municipality, China
Chongqing University Hospital
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
The Affiliated Hospital of Chengde Medical College
Chengde, Hebei, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China
The Affiliated Hospital of Xuzhou Medical University
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Affiliated Hospital Of Soochow University
Suzhou, Jiangsu, China
Jinzhou Central Hospital
Wuxi, Jiangsu, China
Jilin Cancer Hospital
Changchun, Jilin, China
The First Hospital of Jilin University
Changchun, Jilin, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China
Binzhou Medical University Hospital
Binzhou, Shandong, China
Linyi People's Hospital
Linyi, Shandong, China
Shanghai Huashan Hospital
Shanghai, Shanghai Municipality, China
Tongji hospital of Tongji University
Shanghai, Shanghai Municipality, China
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Institute of Dematology & Blood diseases Hospital
Tianjin, Tianjin Municipality, China
Xinjiang Uygur Autonomous Region People's Hospital
Ürümqi, Xinjiang, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
Countries
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Other Identifiers
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TQB3909-Ib/II-04
Identifier Type: -
Identifier Source: org_study_id