A Phase 1b Multi-cohort Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 5
- 主要终点
- RP2D
研究概览
简要总结
The primary objective of this study is to determine the recommended phase 2 dose (RP2D) and characterize the safety profile of TG-1801. As per protocol v3.0, ublituximab will be discontinued.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •B-cell non-Hodgkin lymphoma (NHL) including Richter's Transformation (RT) and transformed follicular lymphoma (FL), that warrants systemic therapy
- •Chronic Lymphocytic Leukemia (CLL), that warrants systemic therapy as defined by International Workshop on Chronic Lymphocytic Leukemia (iwCLL) (Hallek 2018)
- •Treatment Status:
- •NHL subjects: relapsed to or refractory after at least two prior standard systemic therapies (excluding antibiotics)
- •RT subjects: relapsed or refractory after at least two prior lines of therapy for CLL/ Small lymphocytic lymphoma (SLL) or RT
- •CLL subjects: relapsed to or refractory after at least two prior standard therapies
- •Measurable disease defined as:
- •NHL (including SLL): at least 1 measurable disease lesion > 1.5 centimeters (cm)
- •CLL: at least 1 measurable disease lesion
排除标准
- •Prior therapy with any agent blocking the CD47/SIRPα pathway or any previous CD19 targeting therapy,
- •Subjects receiving cancer therapy (i.e. chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization) or any investigational drug within 21 days of Cycle 1 Day
- •Prior autologous stem cell transplant (SCT) within 6 months.
研究组 & 干预措施
Cohort C: TG-1801 + Ublituximab
TG-1801 in combination with ublituximab
As per protocol v3.0, ublituximab will be discontinued and the Cohort C is no longer enrolling.
干预措施: TG-1801 (Biological)
Cohort B: TG-1801
TG-1801 Single Agent, escalating doses
干预措施: TG-1801 (Biological)
Cohort A: TG-1801
TG-1801 Single Agent
As per protocol v3.0, Cohort A is no longer enrolling.
干预措施: TG-1801 (Biological)
Cohort C: TG-1801 + Ublituximab
TG-1801 in combination with ublituximab
As per protocol v3.0, ublituximab will be discontinued and the Cohort C is no longer enrolling.
干预措施: Ublituximab (Biological)
结局指标
主要结局
RP2D
时间窗: Up to 24 months
To determine the recommended Phase 2 dose (RP2D)
次要结局
- Overall Response Rate(Up to 24 months)