JS203 Combination Regimens in B-Cell Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
To evaluate the preliminary efficacy of JS203 combined with standard regimens in patients with B-cell Non-Hodgkin's lymphoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all of the following inclusion criteria to be enrolled：
- •Age range: 18 to 80 years old (inclusive), both male and female are acceptable；
- •ECOG: 0-2；
- •B-cell non-Hodgkin's lymphoma expressing CD20 antigen that has been pathologically diagnosed；
- •At least one measurable lesion meeting the criteria specified in the Lugano 2014 response assessment； Acceptable organ function at screening；
排除标准
- •A history of severe allergy to monoclonal antibody therapy (or recombinant antibody-related fusion protein)；
- •Previously received CD20-CD3 bispecific antibody treatment；
- •Previous allogeneic hematopoietic stem cell transplantation；
- •Previous solid organ transplantation；
- •History of autoimmune diseases；
- •Patients with a history of macrophage activation syndrome (MAS)/ hemophagocytic lymphohistiocytosis (HLH)；
- •Patients with a history of progressive multifocal leukoencephalopathy (PML)；
- •A known or suspected history of CNS lymphoma (including primary or secondary)；
- •There is pleural effusion, peritoneal effusion or pericardial effusion that requires treatment (such as puncture or drainage)；
研究组 & 干预措施
MCL-Lena
In participants with relapsed/refractory mantle cell lymphoma
干预措施: JS203 combined with lenalidomide (Drug)
DLBCL-Gemox
In participants with relapsed/refractory diffuse large B cell lymphoma ineligible for ASCT
干预措施: JS203 in combination with gemcitabine and oxaliplatin (Drug)
DLBCL-ICE
In participants with relapsed/refractory diffuse large B cell lymphoma intended for ASCT
干预措施: JS203 in combination with ifosfamide, carboplatin and etoposide (Drug)
DLBCL- RCHOP
In participants with newly diagnosed diffuse large B cell lymphoma
干预措施: JS203 in combination with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (Drug)
FL-Lena
In participants with relapsed/refractory follicular lymphoma
干预措施: JS203 combined with lenalidomide (Drug)
MZL-Lena
In participants with relapsed/refractory marginal zone lymphoma
干预措施: JS203 combined with lenalidomide (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: up to approximately 15 months
Objective response rate (ORR) based on 2014 Lugano criteria
次要结局
- complete response (CR)(up to approximately 24 months)
- Progression-free survival (PFS)(up to approximately 24 months)
- Overall survival (OS)(up to approximately 24 months)
- NAb(Up to approximately 24 months)
- Duration of response (DoR)(up to approximately 24 months)
- Time to response (TTR)(up to approximately 24 months)
- PK(up to approximately 24 months)
- ADA(up to approximately 24 months)
- Duration of complete response (DoCR)(up to approximately 24 months)
- Adverse events (AE)(up to approximately 24 months)