A Phase Ⅰ/Ⅱ, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of GB261 in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 460
- 试验地点
- 6
- 主要终点
- Dose Limiting Toxicity
研究概览
简要总结
This is a Phase 1/2 study of GB261 in participants with relapsed or refractory B-cell NHL and CLL. The study will consist of a dose-escalation stage(Phase 1), an expansion stage(Phase 2a) and Phase 2b stage where participants will be enrolled into indication-specific cohorts.
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
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •CD20+ B-cell Non-Hodgkin Lymphoma or CLL who have relapsed or failed to respond to at least one prior treatment regimen and for whom there is no available therapy expected to improve survival
- •Adequate hepatic, hematologic, and renal function
排除标准
- •Burkitt lymphoma, lymphoplasmacytic lymphoma or B lymphoblastic leukemia
- •Prior treatment with systemic anti-lymphoma therapy within 4 weeks or five half-lives of the drug (which is shorter) prior to the first GB261 infusion
- •History of auto-SCT or CAR-T therapy in the past 180 days and/or with any of protocol specified conditions
- •Prior allo-SCT or allogeneic CAR-T
- •Prior solid organ transplantation
- •Autoimmune disease with the exceptions specified in the protocol
- •History of central nervous system(CNS) lymphoma or other CNS disease
- •Significant cardiovascular or pulmonary disease
- •Hepatitis B or C or human immunodeficiency virus (HIV)
- •Pregnant or lactating or intending to become pregnant during the study
研究组 & 干预措施
GB261
Participants will receive GB261 via intravenous (IV) infusion as a single agent on Day 1, Day 8 and Day 15 of Cycle 1 and 2 followed by Day 1 of each cycle（21 days per cycle） afterwards until disease progression or other situations specified in the protocol, whichever comes earlier.
干预措施: GB261 (Biological)
结局指标
主要结局
Dose Limiting Toxicity
时间窗: During Cycle 1 (up to 21 days)
Maximum Tolerated Dose
时间窗: During Cycle 1 (up to 21 days)
Objective Response Rate
时间窗: Through study completion, an average of 3 years
Percentage of participants with adverse events
时间窗: From first dosing until 90 days after the last treatment
次要结局
- Area Under the Curve(At predefined intervals up to 106 days)
- Duration of Objective Response(Through study completion, an average of 3 years)
- Clearance(At predefined intervals up to 106 days)
- Vz(At predefined intervals up to 106 days)
- Anti-Drug Antibody(At predefined intervals up to 3 years)
- Progression Free Survival(Through study completion, an average of 3 years)
- t1/2(At predefined intervals up to 106 days)
- Duration of Objective Complete Response(Through study completion, an average of 3 years)
- Cmax(At predefined intervals up to 106 days)
- Tmax(At predefined intervals up to 106 days)
- Overall Survival(Through study completion, an average of 3 years)