A Clinical Trial on the Safety and Efficacy of TQB3909 Tablets in Patients With Recurrent or Refractory Chronic Lymphocytic Leukemia (CLL) /Small Lymphocytic Lymphoma (SLL) .

Last updated: October 19, 2023
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Lymphocytic Leukemia, Chronic

Marginal Zone Lymphoma

Leukemia

Treatment

TQB3909 tablet

Clinical Study ID

NCT05959694
TQB3909-Ib/II-02
  • Ages 18-75
  • All Genders

Study Summary

This is a phase Ib/II clinical trial to evaluate the safety and efficacy of TQB3909 tablets in patients with recurrent or refractory CLL/SLL.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The subjects volunteered to join the study and signed informed consent form (ICF) withgood compliance;
  • Age: ≥ 18 years old, ≤75 years old (when signing ICF); Eastern Cooperative OncologyGroup Performance Status (ECOG PS) score: 0-1; The expected survival period is morethan 3 months;
  • Subjects: patients diagnosed as CLL/SLL according to the revised diagnostic criteriaof 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines;
  • Computed Tomography / Magnetic Resonance Imaging (CT/MRI) of patients with SLL showedmeasurable lesions;
  • Female subjects of childbearing age should agree to use contraceptive measures (suchas intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; serum pregnancy/urine pregnancy test within 7days before study enrollment;

Exclusion

Exclusion Criteria:

  • Complicated diseases and medical history:
  1. It has appeared or is currently suffering from other malignant tumors within 3years before the first medication. The following two situations can be includedin the group: other malignant tumors treated by single surgery have achieveddisease-free survival (DFS) for five consecutive years; Cured cervical carcinomain situ, non-melanoma skin cancer and superficial bladder tumor [Ta (non-invasivetumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)];
  2. Lymphoma/leukemia is known to involve the central nervous system (CNS);
  3. Previously received allogeneic hematopoietic stem cell transplantation;
  4. Received autologous hematopoietic stem cell transplantation within 3 monthsbefore the first medication;
  5. Unresolved toxic reaction ≥ CTCAE grade 1 caused by any previous treatment;
  6. Arterial/venous thrombotic events occurred within 6 months before the firstmedication, such as cerebrovascular accidents (including transient ischemicattack, cerebral hemorrhage and cerebral infarction), deep venous thrombosis andpulmonary embolism;
  7. Subjects with any serious and/or uncontrollable diseases;
  • Tumor-related symptoms and treatment:
  1. He has received chemotherapy and radiotherapy within 4 weeks before the firstmedication, immune checkpoint inhibitor and Chimeric Antigen Receptor T (CAR-T)-Cell Immunotherapy within 12 weeks before the first medication, and othersmall molecule anti-tumor treatments (the elution period is calculated from theend of the last treatment) before the first medication are within 5 half-lives;
  2. previously received BCL-2 inhibitors;
  • Research-related treatment: received the vaccine within 4 weeks before the firstmedication, or planned to be vaccinated during the study;
  • Participated in clinical trials of other antineoplastic drugs within 4 weeks beforethe first medication;
  • According to the investigators' judgment, there are patients with accompanyingdiseases that seriously endanger the safety of the subjects or affect the completionof the study, or subjects who think that there are other reasons that are not suitablefor inclusion.
  • Allergic to allopurinol and benzbromarone.

Study Design

Total Participants: 107
Treatment Group(s): 1
Primary Treatment: TQB3909 tablet
Phase: 1/2
Study Start date:
October 11, 2023
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Anqing Municipal Hospital

    Anqing, Anhui 246004
    China

    Active - Recruiting

  • Gansu province Wuwei tumour hospital

    Wuwei, Gansu 733000
    China

    Active - Recruiting

  • Sun Yat-Sen University Cancer Canter

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

  • Affiliated Hospital of Chengde Medical College

    Chengde, Hebei 067400
    China

    Active - Recruiting

  • Harbin first hospital

    Harbin, Heilongjiang 150000
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang 150000
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan 450003
    China

    Active - Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan 410029
    China

    Active - Recruiting

  • Jiangsu Provincial People's Hospital

    Nanjing, Jiangsu 210029
    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

  • Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu 221000
    China

    Active - Recruiting

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi 330029
    China

    Active - Recruiting

  • Shengjing Hospital Affiliated to China Medical University

    Shenyang, Liaoning 110000
    China

    Active - Recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong 250063
    China

    Active - Recruiting

  • Linyi people's hospital

    Linyi, Shandong 276002
    China

    Active - Recruiting

  • Tai 'an Central Hospital

    Tai'an, Shandong 271000
    China

    Active - Recruiting

  • Shanghai Tongren Hospital

    Shanghai, Shanghai 200050
    China

    Active - Recruiting

  • Peace Hospital Affiliated to Changzhi Medical College

    Changzhi, Shanxi 460000
    China

    Active - Recruiting

  • Affiliated hospital of southwest medical university

    Luzhou, Sichuan 646000
    China

    Active - Recruiting

  • Mianyang Central Hospital

    Mianyang, Sichuan 621000
    China

    Active - Recruiting

  • Yibin Second People's Hospital

    Yibin, Sichuan 644000
    China

    Active - Recruiting

  • Tianjin Cancer Hospital

    Tianjin, Tianjin 300060
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang Uygur Autonomous Region 830054
    China

    Active - Recruiting

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang 315010
    China

    Active - Recruiting

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