NCT07661537招募中1 期
An Open-Label, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SHR-3079 Injection in Participants With B-Cell Non-Hodgkin Lymphoma
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 4
研究概览
简要总结
The study is being conducted to evaluate the safety and tolerability of SHR-3079, and to explore the Dose-limiting Toxicity (DLT), Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D). This study also preliminarily evaluated the efficacy of SHR-3079 in patients with B-cell non-Hodgkin 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
- •Aged ≥ 18 years old;
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1, expected survival ≥ 3 months;
- •Histologically confirmed B-NHL;
- •Participant population: Have received ≥ 1 line of standard anti-tumor treatment, and have not achieved response after the latest treatment or have progressive disease after the treatment;
- •Have measurable lesions;
- •Have adequate organ function;
- •Male participants and female participants of childbearing potential must use adequate and effective contraceptive measures during the study and within 3 months after the last drug administration of SHR-
- •Female participants must not be lactating and must have a negative blood HCG test result within 7 days before the first dose;
- •Voluntarily sign the ICF, have good compliance, and be willing to cooperate with follow-up.
排除标准
- •Central nervous system (CNS) infiltration;
- •Prior chemotherapy or other anti-lymphoma agents administered within 4 weeks before the first dose of study treatment;
- •Major surgery within 4 weeks before signing the ICF, or plan to undergo major surgery during the study period;
- •Receipt of CAR-T therapy or autologous stem cell transplant within 12 weeks prior to enrollment;
- •Receipt of allogeneic hematopoietic stem cell transplantation;
- •Prior solid organ transplantation;
- •Positive hepatitis C virus (HCV) antibody with HCV-RNA copy number above the upper limit of normal of the study site; positive hepatitis B surface antigen [HBsAg] and/or positive hepatitis B core antibody (HBcAb) with HBV DNA copy number above the upper limit of normal of the study site;
- •Presence of severe disorders involving major organ systems;
- •Pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention;
- •Pregnant, lactating women, or women planning to become pregnant;
- •Have other serious physical or mental illness, laboratory test abnormalities, or other factors that may increase the risk of study participation or interfere with the study results.
研究组 & 干预措施
SHR-3079 Group
Experimental
SHR-3079.
干预措施: SHR-3079 Injection (Drug)
研究者
研究点 (4)
Loading locations...
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