A Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Phase I/II Study of ZG005 in Combination With Gecacitinib in Patients With Relapsed or Refractory Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
PART 1:
- To explore the safety of ZG005 in combination with Gecacitinib in patients with relapsed or refractory lymphoma.
- To determine the recommended Phase II dosing regimen for relapsed or refractory lymphoma.
PART 2:
To evaluate the efficacy of ZG005 in combination with Gecacitinib in patients with relapsed or refractory lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Fully understand this study and voluntarily sign the ICF；
- •Age ≥18 at ICF signing, regardless of gender；
- •Histologically confirmed relapsed or refractory lymphoma.
排除标准
- •Lymphoma with known CNS involvement；
- •Severe cardiovascular/cerebrovascular diseases.
- •Any other reason deeming the participant unsuitable for the study, as judged by the investigator.
研究组 & 干预措施
Part 1: Plan A
ZG005（20mg/kg Q3W）+Gecacitinib（Gecacitinib is administered continuously until the end of treatment）
干预措施: ZG005 for Injection (Biological)
Part 1: Plan A
ZG005（20mg/kg Q3W）+Gecacitinib（Gecacitinib is administered continuously until the end of treatment）
干预措施: Gecacitinib Hydrochloride Tablets (Drug)
Part 1: Plan B
ZG005（20mg/kg Q3W）+Gecacitinib（Gecacitinib is administered continuously from CnD1 to D14, and discontinued from CnD15 to D21）
干预措施: ZG005 for Injection (Biological)
Part 1: Plan B
ZG005（20mg/kg Q3W）+Gecacitinib（Gecacitinib is administered continuously from CnD1 to D14, and discontinued from CnD15 to D21）
干预措施: Gecacitinib Hydrochloride Tablets (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Up to 2 years
次要结局
- Immunogenicity(Up to 2 years)