NCT06368167尚未招募2 期
A Phase II, Single-arm, Open-label, Multicenter Study on the Efficacy of SHR2554 in Patients With Relapsed or Refractory Follicular Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR) assessed by independent review committee (IRC)
研究概览
简要总结
The study is being conducted to evaluate the efficacy and safety of SHR2554 in Patients with Relapsed or Refractory Follicular Lymphoma
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
- •Males or females aged ≥18 years
- •Histologically confirmed follicular lymphoma
- •Eastern Cooperative Oncology Group performance status (ECOG PS) score ≤2
- •Life expectancy ≥ 12 weeks
- •Treated with CD20 antibody, refractory to or relapse from prior anti-cancer therapies
- •Have measurable lesions
- •The subject is willing and able to comply with the visit schedule, dosing schedule, laboratory tests, and other clinical study procedures
排除标准
- •Have been treated with a compound of the same machanism;
- •Accompanied by central nervous system infiltration;
- •Received autologous stem cell transplantation within 60 days before signing the agreement, and received allogeneic stem cell transplantation or CAR-T therapy within 90 days;
- •Underwent major surgery or experienced severe trauma within 4 weeks prior to the first dose of the investigational drug
- •Known active infection
- •History of clinically severe cardiovascular diseases
- •Have other malignancies within 5 years prior to screening Pregnant or lactating women
- •The subject is unable to swallow, or has a history of active gastrointestinal inflammation, chronic diarrhea, known diverticulosis, or a history of gastrectomy or gastric banding that affects drug absorption.
- •The subject is taking a known medium or strong CYP inducer.
- •Based on the investigator's judgment, there are objective conditions that may prevent the subject from completing the study as planned or the subject has other factors, concomitant diseases, concomitant treatments, or abnormal laboratory findings that may lead to early study termination
研究组 & 干预措施
SHR2554
Experimental
干预措施: SHR2554 (Drug)
结局指标
主要结局
Objective response rate (ORR) assessed by independent review committee (IRC)
时间窗: around 1 year
percentage of patients who achieve completes response(CR) or partial response(PR) in the study
次要结局
- Duration of response(around 1 year)
- Progression free survival(around 1 year)
- Overall survival(around 5 years)
- ORR assessed by investigator(around 1 year)
- Time to Response(around 4 months)
研究者
研究点 (1)
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