A Phase Ib, Open Label, Randomized, Multicenter Study of the Efficacy and Safety of IBI110 Single Agent and in Combination With Sintilimab for Patients With Relapsed or Refractory Diffuse Large B Cell Lymphoma (r/r DLBCL)
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
The purpose of this study is to determine whether treatment with IBI110 single agent and in combination with sintilimab demonstrates sufficient efficacy/safety in r/r DLBCL.
详细描述
This is a phase Ib, open-label, randomized study to determine the efficacy and safety of treatment with IBI110 single agent and in combination with sintilimab in DLBCL that are relapsed and/or refractory to available standard of care therapies.
Participants in each cohort are randomly assigned to one of the two arms: IBI110 single agent arm and IBI110 in combination with sintilimab arm. Participants received study treatment for a maximum of 2 years, or until disease progression (assessed by investigator per Lugano 2014 Criteria for Malignant Lymphoma (Cheson et al 2014)), unacceptable toxicity, death or discontinuation from study treatment for any other reason.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide signed written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- •Male or female, 18-70 years old (at the time consent is obtained)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Histologically confirmed diagnosis of DLBCL in a subject who has been pretreated with at least 2 lines of systematic treatment (regimens containing anthracyclines and anti-CD20 immunotherapy must be included);
- •Subjects whose most recent therapy was CAR-T cell therapy were also eligible.
排除标准
- •Patients previously exposed to any anti-LAG-3 treatment.
- •History of ≥Grade 3 CRS, neurotoxicity, or hemophagocytic lymphohistiocytosis) during previous CAR-T cell therapy.
- •Impaired cardiac function or clinically significant cardiac disease.
- •Active, known or suspected autoimmune disease or a documented history of autoimmune disease within two years prior to screening with a few exceptions as per protocol.
研究组 & 干预措施
Single agent treatment arm with IBI110
IBI110 administered at RP2D
干预措施: IBI110 (Drug)
Combination treatment arm with IBI10 and sintilimab
IBI110 and sintilimab administered at RP2D
干预措施: IBI110 plus sintilimab (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Up to 24 months
Percentage of subjects achieving complete remission and partial remission in the studied cohort
The frequency of adverse events (adverse events, AEs) and serious adverse events (SAEs)
时间窗: Up to 24 months
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAE were defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline.
次要结局
- complete response rate(Up to 24 months)
- DoR(Up to 24 months)
- PFS(Up to 24 months)
- OS(Up to 24 months)