NCT04002622终止2 期
A Phase II, Multicenter, Open, Single-arm Study of TQB2450 Injection (PD-L1 Antibody) in Subjects With Relapsed or Refractory Primary Mediastinal B-cell Lymphoma (rrPMBCL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 18
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
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
- •Histologically confirmed relapsed or refractory primary mediastinal large B-cell lymphoma.
- •18 and 75 years; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Life expectancy > 3 months.
- •At least one measurable lesion.
- •Left ventricular ejection fraction (LVEF) measured by the cardiac echocardiography ≥ 50%.
- •Screening laboratory values must meet the following criteria:hemoglobin ≥ 80 g/L; neutrophils ≥ 1.5*10^9/L; platelets ≥ 100 x 10^9/ L.
- •Understood and signed an informed consent form.
排除标准
- •Hypersensitivity to recombinant humanized anti-PD-1 monoclonal Abm or its components.
- •Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody ,or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- •Has received chemotherapy, surgery, radiotherapy, the last treatment from the first dose less than 4 weeks, or oral targeted drugs for less than 5 half-lives, or oral fluorouracil pyridine drugs for less than 14 days, mitomycin C and nitrosourea for less than 6 weeks.
- •Has received emergency cytoreductive surgery to control tumors.
- •Has received allogeneic hematopoietic stem cell transplantation within the last 5 years.
- •Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade
- •Has diagnosed and/or treated additional malignancy within 5 years prior to randomization. Exceptions include basal cell skin cancer, squamous cell carcinoma of skin, melanoma skin and cancer carcinoma in situ of the cervix.
- •Has definite central nervous system (CNS) infiltration of lymphoma, including brain parenchyma, meningeal invasion or spinal cord compression.
- •Has any active autoimmune disease or a history of autoimmune disease.
- •Has serious or uncontrolled diseases such as history of chronic heart failure.
- •Has any active autoimmune disease or a history of autoimmune disease.
- •Has received blood transfusion, erythropoietin granulocyte colony stimulating factor(G -CSF)，or Granulocyte macrophage colony stimulating factor(GM-CSF) within 4 weeks before the first dose.
- •Has vaccinated with vaccines or attenuated vaccines within 4 weeks before the first dose.
- •Has received surgery, or unhealed wounds within 4 weeks before the first dose.
- •Has Hepatic, renal, blood coagulation dysfunction.
- •Has interstitial lung disease or non-infectious pneumonia and present residual lesions.
- •Has received systemic treatment for active infection before the first dose.
- •Has active or latent tuberculosis.
- •Hepatitis B virus surface antigen (HBsAg) positive, and hepatitis B virus DNA copy number > upper limit of normal.
- •Human immunodeficiency virus antibody positive , hepatitis C antibody (HCV-Ab) and hepatitis C virus DNA copy number > upper limit of normal.
- •Breastfeeding or pregnant women.
- •According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
研究组 & 干预措施
TQB2450
Experimental
TQB2450 1200 milligrams (mg) administered intravenously (IV) on Day 1 of each 21-day cycle.
干预措施: TQB2450 (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: up to 96 weeks
Percentage of subjects achieving complete response (CR) and partial response (PR).
次要结局
- Disease Control Rate (DCR)(up to 24 months)
- Progression-Free Survival (PFS)(up to 96 weeks)
- Duration of Response (DOR)(up to 96 weeks)
- Time to Response (TTR)(up to 24 months)
- Overall Survival (OS)(up to 24 months)
研究者
研究点 (18)
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