A Phase 1, Open-label, Dose-escalation Study of SGN-CD19B in Patients With Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Seagen Inc.
- 入组人数
- 44
- 试验地点
- 16
- 主要终点
- Incidence of adverse events
研究概览
简要总结
The study will examine the safety profile of SGN-CD19B administered as a single agent. The main purpose of the study is to estimate the highest dose that does not cause unacceptable side effects of SGN-CD19B in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (NHL) subtypes of diffuse large B-cell lymphoma (DLBCL) and Grade 3 follicular lymphoma (FL3). Additionally, the pharmacokinetic profile and antitumor activity of SGN-CD19B will be assessed.
详细描述
SGN-CD19B will be given to patients at increasing doses every 28 days (or on an alternative dosing schedule of every 42 days).
Individual expansion cohorts of up to approximately 20 patients will be opened at dose levels selected by the Safety Monitoring Committee based on the aggregate known safety and activity data to further define the safety and antitumor activity in refractory and relapsed disease subgroups.
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
- •Relapsed, refractory, or progressive disease following at least 2 prior systemic therapies
- •Measurable disease
- •Eastern Cooperative Oncology Group status of 0 or 1
- •Adequate baseline renal and hepatic function
排除标准
- •Prior treatment with CD19 directed agents unless CD19 expression is confirmed after completion of CD19-directed treatment
- •Known HIV, active hepatitis B or active hepatitis C infection
- •Prior allogeneic stem cell transplant
- •Inadequate lung function
- •Anticancer treatment within 4 weeks of study drug or 2 weeks if patient experienced disease progression on prior treatment
研究组 & 干预措施
SGN-CD19B
干预措施: SGN-CD19B (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: Through 1 month following last dose
Incidence of laboratory abnormalities
时间窗: Through 1 month following last dose
次要结局
- Blood concentrations of SGN-CD19B(Through 3 weeks after dosing)
- Incidence of antitherapeutic antibodies(Through 1 month following last dose)
- Objective response rate(Through 1 month following last dose)
- Rate of response(Through 1 month following last dose)
- Progression-free survival(Up to approximately 3 years)