NCT04948788Unknown2 期
A Phase I/ II Study of SHR1459 in Combination With YY-20394 in Recurrent and Refractory B-cell Non-Hodgkin's Lymphoma in Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Stage 1: MTD （Maximum tolerated dose）or RP2D（Recommended Phase II Dose) of SHR1459 and YY-20394;
研究概览
简要总结
The study is evaluating the efficacy, and safety of SHR1459 combined with YY-20394 for Recurrent and refractory B-cell non-Hodgkin's lymphoma in adults.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of B-cell NHL such as DLBCL, FL and MCL
- •Patients received at least 2 lines of systemic therapy
- •Previously received anti- CD20 treatment
- •Patients in stage II should also be unsuitable or unwilling to receive allogeneic hematopoietic stem cell transplantation
- •Patients must have an acceptable organ function
排除标准
- •Previously treated with PI3K inhibitors or BTK inhibitors
- •Unresolved toxicity of CTCAE grade > 1 from prior anti-lymphoma therapy
- •Chemotherapy or other investigational therapy within 28 days (or 5 times the half-life time, whichever is shorter) before starting cycle 1
- •Significant concurrent medical disease or condition which according to the investigators' judgement
- •Active hepatitis B, C or HIV infection
- •Infection requiring treatment 2 weeks prior to the first dosing
研究组 & 干预措施
SHR1459 + YY-20394 (Stage 1)
Experimental
干预措施: SHR1459 ；YY-20394 (Drug)
SHR1459 + YY-20394 (Stage 2)
Experimental
干预措施: SHR1459 ；YY-20394 (Drug)
GemOx (Stage 2)
Experimental
干预措施: Gemcitabine-Oxaliplatin (Drug)
结局指标
主要结局
Stage 1: MTD （Maximum tolerated dose）or RP2D（Recommended Phase II Dose) of SHR1459 and YY-20394;
时间窗: Minimum observation period is 28 days for the maximum dose cohort
Stage 2: Overall response rate (ORR)
时间窗: 8 weeks after last patient first visit (LPFV)
次要结局
- Incidence of Adverse Events(At every treatment and follow up visit until disease progression. Expected to be for up to 6 months)
研究者
研究点 (1)
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