A Clinical Study to Evaluate the Efficacy and Safety of TQB3702 Tablets Combined With Immunochemotherapy for the Treatment of B-cell Lymphoma

Last updated: November 18, 2024
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoma

Lymphoma, B-cell

Lymphoproliferative Disorders

Treatment

TQB3702 tablets+Chemotherapy regimen

Clinical Study ID

NCT06566586
TQB3702-II-02
  • Ages 18-75
  • All Genders

Study Summary

To evaluate the efficacy and safety of TQB3702 tablets combined with immunochemotherapy for the treatment of B-cell lymphoma

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The subjects voluntarily joined the study, signed the informed consent, and thecompliance was good;

  • Age: 18 years old ≤ age (when signing the informed consent) ≤75 years old; Easterncooperative oncology group (ECOG) score: 0-2; Expected survival of more than 3months;

  • Histologically confirmed B-cell lymphomas of the following types that meet the 2022World Health Organization (WHO) diagnostic criteria:

  1. Relapsed/refractory indolent B-cell lymphoma

  2. Diffuse large B cell lymphoma(DLBCL)

  • Previous treatment: Relapsed/refractory inert B-cell lymphoma: have received atleast one previous line of systemic standard therapy

  • Have at least one measurable lesion.

  • The main organs function well.

  • Female subjects of reproductive age should agree to use contraception (such as Iuds,contraceptives, or condoms) during the study period and for 6 months after the endof the study; Have a negative serum pregnancy test within 7 days prior to studyenrollment and must be a non-lactating subject; Male subjects should agree to useavoidance during the study period and for 6 months after the end of the studyperiod.

Exclusion

Exclusion Criteria:

  • Have had or are currently suffering from other malignant tumors within 3 years priorto the first medication.

  • Known or suspected central nervous system (CNS) aggression.

  • Relapsed/refractory inert B-cell lymphoma: previous allogeneic hematopoietic stemcell transplantation, or autologous hematopoietic stem cell transplantation within 3months before the first treatment;

  • Recurrent/refractory indolent B-cell lymphoma: toxic reactions that do not return to ≤ National Cancer Institute standard for common toxic reactions (NCI-CTC) AE Grade 1due to any previous treatment, excluding hair loss and fatigue;

  • Have multiple factors that affect oral drug absorption (such as inability toswallow, chronic diarrhea, and intestinal obstruction);

  • Received major surgical treatment or significant traumatic injury within 28 daysbefore the start of study treatment;

  • Hyperkinetic/venous thrombosis events occurred within 6 months before the firstmedication;

  • Have a history of psychotropic drug abuse and can not quit or have mental disorders;

  • Subjects with any severe and/or uncontrolled disease;

  • Received live vaccine or messenger ribonucleic acid (mRNA) vaccine within 4 weeksbefore the first dose, or planned to receive live vaccine or mRNA vaccine during thestudy;

  • Participated in clinical trials of other antitumor drugs within 4 weeks before thefirst medication;

  • Subjects who, in the judgment of the investigator, have concomitant diseases thatseriously endanger the safety of the subjects or affect the completion of the study,or subjects who are not suitable for enrollment for other reasons.

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: TQB3702 tablets+Chemotherapy regimen
Phase: 2
Study Start date:
November 06, 2024
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Cancer Hospital Chinise Academy of Medical Sciences

    BeiJing, Beijing 100021
    China

    Site Not Available

  • Gansu Provincial Cancer Hospital

    Lanzhou, Gansu 730000
    China

    Site Not Available

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510000
    China

    Site Not Available

  • Guigang City People's Hospital

    Guigang, Guangxi 537000
    China

    Site Not Available

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi 530021
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang 150000
    China

    Site Not Available

  • PuYang AnYang District Hospital

    Anyang, Henan 450000
    China

    Site Not Available

  • Puyang People's Hospital

    Puyang, Henan 457000
    China

    Site Not Available

  • Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University

    Zhengzhou, Henan 457000
    China

    Site Not Available

  • Henan Provincial People's Hospital

    Zhengzhou, Henan 450000
    China

    Site Not Available

  • Tongji Hospital Tongji Medical College of HUST

    Wuhan, Hubei 430030
    China

    Site Not Available

  • Union Hosiptal, Tongji Medical College, Huazhong University of Science And Technolocy

    Wuhan, Hubei 430022
    China

    Site Not Available

  • Xiangyang Central Hospital

    XiangYang, Hubei 441000
    China

    Site Not Available

  • Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University

    Changsha, Hunan 410013
    China

    Site Not Available

  • Zhuzhou Central Hospital

    Zhuzhou, Hunan 412000
    China

    Site Not Available

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia 10000
    China

    Site Not Available

  • Jiangsu Provincial People's Hospital

    Nanjing, Jiangsu 210000
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • The second Hospital of dalian

    Dalian, Liaoning 116000
    China

    Site Not Available

  • The Second Affiliated Hospital Of Xi'an Jiaotong University(Xibei Hospital)

    Xi'an, Shaanxi 710004
    China

    Site Not Available

  • Affiliated Cancer Hospital of Shandong First Medical University

    Jinan, Shandong 250117
    China

    Active - Recruiting

  • Tai'an Central Hospital

    Tai'an, Shandong 271000
    China

    Site Not Available

  • Tongji Hospital of Tongji University

    Shanghai, Shanghai 200063
    China

    Site Not Available

  • Shanxi Cancer Hospital

    TaiYuan, Shanxi 030000
    China

    Site Not Available

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan 646000
    China

    Site Not Available

  • Zigong First People's Hospital

    Zigong, Sichuan 643000
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin 300202
    China

    Site Not Available

  • Tianjin People's Hospital

    Tianjin, Tianjin 300122
    China

    Site Not Available

  • Affiliated Tumor Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang 830000
    China

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.