A Phase 1, Open-label, Multicenter Study of LTZ-301 in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 9
- 主要终点
- Safety and Tolerability
研究概览
简要总结
This study is a first-in-human (FIH), Phase 1, multicenter, open-label study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and evaluate the preliminary anti-tumor activity of LTZ-301 administered as a single agent in adult subjects with relapsed or refractory B-cell non-Hodgkin lymphoma
详细描述
LTZ-301 is a bispecific antibody which is a Myeloid cell engager, which targets B-cells via CD79B, and triggers phagocytosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Age ≥ 18 years
- •Relapsed or refractory to at least 2 prior systemic treatment regimens
- •At least 1 bi-dimensionally measurable lesion (≥ 1.5 cm) in longest dimension
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •Adequate bone marrow, cardiac, pulmonary, renal, and hepatic function
排除标准
- •CLL, or Richters transformation
- •Prior solid organ transplant
- •Prior allogeneic stem cell transplant
- •ASCT within 100 days prior to the first LTZ-301 administration
- •Prior CAR-T within 60 days prior to the first LTZ-301 administration
- •Current central nervous system (CNS) lymphoma
- •Known history of human immunodeficiency virus (HIV) seropositivity
- •Active autoimmune disease
- •History of clinically significant cardiovascular disease
- •symptomatic deep vein thrombosis (DVT) within 3 months of enrollment
- •History of other malignancy within 3 years prior to screening
研究组 & 干预措施
Dose Escalation
Subjects in this arm will participate in one (1) of eight (8) escalating defined dose level cohorts. Subjects will receive up to 54 weeks of LTZ-301 intravenously.
干预措施: LTZ-301 (Biological)
Expansion
A dose level will be selected to enroll additional subjects to explore safety, tolerability, and clinical activity for a selected lymphoma type.
干预措施: LTZ-301 (Biological)
Backfill Expansion
Subjects may be dosed at levels previously declared safe to further explore safety, tolerability, and clinical activity at particular dose levels.
干预措施: LTZ-301 (Biological)
结局指标
主要结局
Safety and Tolerability
时间窗: Up to 54 weeks
To determine the incidence of adverse events according to CTCAE v5.0 and meeting protocol defined and dose limiting toxicity criteria.
次要结局
未报告次要终点