NCT06106841终止1 期
A Phase Ib/II Clinical Trial of TQB3909 Tablets in Subjects With Relapsed or Refractory MCL Safety and Efficacy
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.28 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2023年10月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 28
- 主要终点
- Recommended phase II dose (RP2D)
研究概览
简要总结
This is a study to assess the safety of TQB3909 monotherapy in participants with relapsed or refractory MCL.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject voluntarily joins the study, signs the informed consent form, and has good compliance;
- •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.
排除标准
- •Have had or currently have other malignant tumors within 3 years before the first dose of 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 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.);
- •Unmitigated toxicity ≥ Common Terminology Criteria for Adverse Events (CTCAE) grade 2 due to any prior treatment (except hair loss, absolute neutrophil count and platelet abnormalities, which follow the inclusion criteria 4);
- •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.
研究组 & 干预措施
400mg of TQB3909 tablets
Experimental
tablet, 28 days as a treatment cycle.
干预措施: 400mg of TQB3909 tablets (Drug)
600mg of TQB3909 tablets
Experimental
tablet, 28 days as a treatment cycle.
干预措施: 600mg of TQB3909 tablets (Drug)
结局指标
主要结局
Recommended phase II dose (RP2D)
时间窗: Baseline up to 48-weeks
Recommended phase II dose (RP2D)
次要结局
- The severity of abnormal laboratory examination indicators(Baseline up to 96-weeks)
- The incidence of adverse events (AEs)(Baseline up to 96-weeks)
- The severity of severe adverse events (SAEs)(Baseline up to 96-weeks)
- The severity of adverse events (AEs)(Baseline up to 96-weeks)
研究者
研究点 (28)
Loading locations...
相似试验
招募中
1 期
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) .Small Lymphocytic LymphomaChronic Lymphocytic LeukemiaNCT05959694Chia Tai Tianqing Pharmaceutical Group Co., Ltd.107
Unknown
2 期
A Study of TQ-B3101 in Subjects With Relapsed or Refractory Anaplastic Large Cell Lymphoma (ALCL)Relapsed/Refractory Anaplastic Large Cell Lymphoma (ALCL)NCT04306887Chia Tai Tianqing Pharmaceutical Group Co., Ltd.30
Unknown
2 期
A Study of TQ-B3525 Tablet in the Treatment of Relapsed / Refractory Mantle Cell Lymphoma (MCL)Relapsed / Refractory Mantle Cell Lymphoma (MCL)NCT04398953Chia Tai Tianqing Pharmaceutical Group Co., Ltd.102
尚未招募
1 期
A Clinical Trial to Evaluate the Safety and Tolerability of TQB3911 Tablets in Patients With BCR::ABL Fusion Gene Positive LeukemiaChronic Myelogenous LeukemiaNCT06672263Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.120
暂停
1 期
A Clinical Study to Explore the Safety and Efficacy of CT0991 in Relapsed/Refractory Acute Myeloid LeukemiaRelapsed/Refractory Acute Myeloid Leukemia(AML)NCT06709131He Huang24