A Phase Ib/II Clinical Trial on the Safety and Efficacy of TQB3909 Tablets in Patients With Recurrent or Refractory CLL/SLL.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 107
- 试验地点
- 25
- 主要终点
- Incidence of adverse events (AE)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subjects volunteered to join the study and signed informed consent form (ICF) with good compliance;
- •Age: ≥ 18 years old, ≤75 years old (when signing ICF); Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-1; The expected survival period is more than 3 months;
- •Subjects: patients diagnosed as CLL/SLL according to the revised diagnostic criteria of 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines;
- •Computed Tomography / Magnetic Resonance Imaging (CT/MRI) of patients with SLL showed measurable lesions;
- •Female subjects 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 pregnancy/urine pregnancy test within 7 days before study enrollment;
排除标准
- •Complicated diseases and medical history:
- •It has appeared or is currently suffering from other malignant tumors within 3 years before the first medication. The following two situations can be included in the group: other malignant tumors treated by single surgery have achieved disease-free survival (DFS) for five consecutive years; Cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumor [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)];
- •Lymphoma/leukemia is known to involve the central nervous system (CNS);
- •Previously received allogeneic hematopoietic stem cell transplantation;
- •Received autologous hematopoietic stem cell transplantation within 3 months before the first medication;
- •Unresolved toxic reaction ≥ CTCAE grade 1 caused by any previous treatment;
- •Arterial/venous thrombotic events occurred within 6 months before the first medication, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage and cerebral infarction), deep venous thrombosis and pulmonary embolism;
- •Subjects with any serious and/or uncontrollable diseases;
- •Tumor-related symptoms and treatment:
- •He has received chemotherapy and radiotherapy within 4 weeks before the first medication, immune checkpoint inhibitor and Chimeric Antigen Receptor T (CAR-T)-Cell Immunotherapy within 12 weeks before the first medication, and other small molecule anti-tumor treatments (the elution period is calculated from the end of the last treatment) before the first medication are within 5 half-lives;
- •previously received BCL-2 inhibitors;
- •Research-related treatment: received the vaccine within 4 weeks before the first medication, or planned to be vaccinated during the study;
- •Participated in clinical trials of other antineoplastic drugs within 4 weeks before the first medication;
- •According to the investigators' judgment, there are patients with accompanying diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who think that there are other reasons that are not suitable for inclusion.
- •Allergic to allopurinol and benzbromarone.
研究组 & 干预措施
TQB3909 tablets
Oral administration, 400mg or 600 mg, once a day, and 28 days is a treatment cycle. Continue medication until the disease progresses or intolerant toxicity appears.
干预措施: TQB3909 tablet (Drug)
结局指标
主要结局
Incidence of adverse events (AE)
时间窗: Up to 34 months.
Incidence of AE evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).
Severity of adverse events (AE)
时间窗: Up to 34 months.
Severity of AE evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).
Incidence of serious adverse events (SAE)
时间窗: Up to 34 months.
Incidence of SAE evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).
Severity of serious adverse events (SAE)
时间窗: Up to 34 months.
Severity of SAE evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).
Incidence of abnormal laboratory examination indexes.
时间窗: Up to 34 months.
Incidence of abnormal laboratory examination indexes evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).
Severity of abnormal laboratory examination indexes.
时间窗: Up to 34 months.
Severity of abnormal laboratory examination indexes evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).
Recommended phase II dose (RP2D)
时间窗: Up to 18 months
To determine the recommended phase II dose of TQB3909 tablets in the treatment of recurrent or refractory CLL/SLL.
Objective remission rate (ORR) determined by Independent Review Committee (IRC)
时间窗: Up to 34 months
Determine the objective remission rate (ORR) based on the evaluation results of the Independent Review Committee (IRC), defined as the proportion of subjects whose best remission is complete remission (CR) and partial remission (PR).
次要结局
- Progression-free survival (PFS)(Up to 34 months)
- Time to remission (TTR)(Up to 34 months)
- Time to reach maximum concentration (Tmax)(Within 120 hours after administration)
- Objective remission rate (ORR) determined by the investigators' evaluation.(Up to 34 months)
- Duration of remission (DOR)(Up to 34 months)
- Time to disease progression (TTP)(Up to 34 months)
- Overall survival (OS)(Up to 34 months)
- Maximum plasma drug concentration (Cmax)(Within 120 hours after administration)
- Area under the plasma concentration-time curve (AUC0-t)(Within 120 hours after administration)
- Plasma elimination half-life (t1/2)(Within 120 hours after administration)
- Undetectable measurable residual disease (U-MRD) ratio of peripheral blood and/or bone marrow.(Up to 34 months)
- Correlation between potential biomarkers and TQB3909 tablets.(Up to 34 months)