TQB3909 Tablets in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Last updated: October 26, 2023
Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Lymphoma

Mantle Cell Lymphoma

Lymphoproliferative Disorders

Treatment

600mg of TQB3909 tablets

400mg of TQB3909 tablets

Clinical Study ID

NCT06106841
TQB3909-Ib/II-04
  • Ages > 18
  • All Genders

Study Summary

This is a study to assess the safety of TQB3909 monotherapy in participants with relapsed or refractory MCL.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The subject voluntarily joins the study, signs the informed consent form, and has goodcompliance;
  • Age: ≥ 18 years old (when signing the informed consent form); Eastern CooperativeOncology Group performance status (ECOG PS) score: 0-2 points; Expected survival ismore than 3 months;
  • Subject population: Confirmed as MCL by local laboratory pathology and independentpathology review (stage 2).
  • The main organs are functioning well,
  • The patient's Computed Tomography (CT) / Magnetic Resonance Imaging (MRI) showsmeasurable 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, orcondoms) during the study and for 6 months after the end of the study; Have a negativeserum pregnancy test within 7 days prior to study enrollment and must be anon-lactating subject; Male participants should agree that contraception must be usedduring the study period and for 6 months after the end of the study period.

Exclusion

Exclusion Criteria:

  • Have had or currently have other malignant tumors within 3 years before the first doseof study drug.
  • 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 monthsbefore 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, malabsorptionsyndrome, etc.);
  • Unmitigated toxicity ≥ Common Terminology Criteria for Adverse Events (CTCAE) grade 2due to any prior treatment (except hair loss, absolute neutrophil count and plateletabnormalities, which follow the inclusion criteria 4);
  • Significant surgical treatment and obvious traumatic injury within 28 days prior tothe start of study treatment;
  • Arteriovenous thrombotic events within 3 months before the first dose, such ascerebrovascular accident (including cerebral hemorrhage, cerebral infarction, exceptlacunar cerebral infarction), deep vein thrombosis (except secondary to deep veincatheterization) and pulmonary embolism;
  • Those who have a history of psychotropic substance abuse and cannot be withdrawn orhave mental disorders;
  • Subjects with any severe and/or uncontrolled medical conditions, including:
  • Grade ≥2 myocardial ischemia or myocardial infarction, arrhythmia (Quick Time ConstantFluctuation (QTcF) >450 ms in men, QTcF >470 ms in women) and grade ≥2 congestiveheart failure (New York Heart Association (NYHA) grade), cardiac ultrasound assessmentof left ventricular ejection fraction (LVEF) of <50%; poorly controlled hypertension,defined as systolic blood pressure > 170 mmHg and diastolic blood pressure > 105 mmHgat 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 numberexceeding the upper limit of normal values in the research center;
  • Have a history of immunodeficiency, including Human ImmunodeficiencyVirus(HIV)-positive or other acquired or congenital immunodeficiency diseases, or havea 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-CellImmunotherapy (CAR-T) therapy 12 weeks before the first dose, and received other smallmolecule antitumor therapy (elution period from the end of the last treatment) beforethe 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 bevaccinated during the study;
  • Have participated in other antitumor drug clinical trials within 4 weeks before thefirst dose;
  • According to the judgment of the investigator, there are concomitant diseases thatseriously endanger the safety of subjects or affect the completion of the study, orsubjects who are considered to be unsuitable for enrollment for other reasons.
  • Allergic to allopurinol and benzbromarone.

Study Design

Total Participants: 39
Treatment Group(s): 2
Primary Treatment: 600mg of TQB3909 tablets
Phase: 1/2
Study Start date:
October 05, 2023
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Peking University Third Hospital

    Beijing, Beijing 100191
    China

    Active - Recruiting

  • Chongqing University Hospital

    Chongqing, Chongqing 400030
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian 361003
    China

    Active - Recruiting

  • Gansu Provincial Cancer Hospital

    Lanzhou, Gansu 730050
    China

    Active - Recruiting

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi 530021
    China

    Active - Recruiting

  • The Affiliated Hospital of Chengde Medical College

    Chengde, Hebei 067000
    China

    Active - Recruiting

  • Affiliated Cancer Hospital of Harbin Medical University

    Harbin, Heilongjiang 150081
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang 150001
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan 450000
    China

    Active - Recruiting

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

    Wuhan, Hubei 430050
    China

    Active - Recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Nanjing, Jiangsu 220005
    China

    Active - Recruiting

  • The First Affiliated Hospital Of Soochow University

    Suzhou, Jiangsu 215006
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215004
    China

    Active - Recruiting

  • Jinzhou Central Hospital

    Wuxi, Jiangsu 530031
    China

    Active - Recruiting

  • Jilin Cancer Hospital

    Changchun, Jilin 130012
    China

    Active - Recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin 130022
    China

    Active - Recruiting

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning 116000
    China

    Active - Recruiting

  • Binzhou Medical University Hospital

    Binzhou, Shandong 256603
    China

    Active - Recruiting

  • Linyi People's Hospital

    Linyi, Shandong 276000
    China

    Active - Recruiting

  • Shanghai Huashan Hospital

    Shanghai, Shanghai 200040
    China

    Active - Recruiting

  • Tongji hospital of Tongji University

    Shanghai, Shanghai 200065
    China

    Active - Recruiting

  • Heping Hospital Affiliated to Changzhi Medical College

    Changzhi, Shanxi 046000
    China

    Active - Recruiting

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan 646000
    China

    Active - Recruiting

  • Institute of Dematology & Blood diseases Hospital

    Tianjin, Tianjin 300052
    China

    Active - Recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin 300040
    China

    Active - Recruiting

  • Xinjiang Uygur Autonomous Region People's Hospital

    Ürümqi, Xinjiang 830001
    China

    Active - Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310003
    China

    Active - Recruiting

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang 215006
    China

    Active - Recruiting

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