A Phase 1, Open-Label, Multiple-Dose, Dose-Escalation Study of MDX-1342 in Patients With CD19-Positive Refractory/Relapsed Chronic Lymphocytic Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 6
- 主要终点
- incidence and severity of treatment-emergent adverse events
研究概览
简要总结
The purpose of this study is to see at what dose MDX-1342, a monoclonal antibody, is safe and tolerable for patients with chronic lymphocytic leukemia (CLL). Information on any responses that patients may have to the drug will also be collected.
详细描述
Chronic lymphocytic leukemia (CLL) is a monoclonal hematopoietic disorder characterized by a progressive expansions of lymphocytes of B-cell lineage. These small, mature-appearing lymphocytes accumulate in the blood, bone marrow, lymph nodes, and spleen. CLL is a common leukemia in the wester world and accounts for 25% to 30% of adult leukemias. CD19,an integral membrane protein, is expressed by pro-B cells and functions as a co-stimulatory molecule that regulates mature B-cell activation and enhances B-cell proliferation. MDX-1342, a fully human monoclonal antibody, has demonstrated to specifically bind to human CD19 antigen with high affinity. Therefore, it is theorized that MDX-1342 will block activation of B cell stimulation, decreasing the number of cancerous B cell clones.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •relapsed/refractory CD19-positive CLL
- •At least 28 days since prior treatment for CLL
- •ECOG PS 0-2
- •Screening laboratory values must be met
排除标准
- •No prior anti-CD19 antibody tx
- •No active, uncontrolled infection
- •No prior allogeneic bone marrow transplant
- •No autoimmune disease
结局指标
主要结局
incidence and severity of treatment-emergent adverse events
时间窗: all events will be followed to resolution
次要结局
- response(12 weeks)
- clinical laboratory tests(study duratation - each visit)
- physical examination(study duration - each visit)
- electrocardiogram(at screening and study completion)
- diagnostic testing(at screening and study completion)
- pharmacokinetics sampling(at each dosing visit)