NCT07294300尚未招募1 期
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of QLS2313 for Injection in Patients With Relapsed/Refractory Hematological Malignancies
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- DLT, MTD, RPIbD, and RP2D
研究概览
简要总结
This study is an open-label, dose-escalation and efficacy-expansion Phase I clinical trial to evaluate the safety, tolerability, PK profile, immunogenicity, and preliminary antitumor activity of QLS2313 as a monotherapy in patients with relapsed/refractory hematological malignancies.
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；
- •Patients with relapsed/refractory hematological malignancies, specifically patients with B-cell NHL or CLL/small lymphocytic lymphoma (SLL) as defined by the 2022 World Health Organization (WHO) classification, who are relapsed/refractory and have no standard of care available as judged by the investigator;
- •Having a measurable disease defined by appropriate disease response criteria;
- •Subjects with sufficient organ function prior to the first dose of the investigational drug
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0 or 1
排除标准
- •Previous treatment with a CD79b/CD3/CD20 trispecific antibody；
- •Known central nervous system (CNS) involvement；
- •Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation/bone marrow transplantation；
- •Treatment with autologous stem cell transplantation within 3 months;
- •Prior genetically modified adoptive cell therapy (e.g., chimeric antigen receptor T cells [CAR-T] and natural killer cells [CAR-NK]) within 3 months
- •Presence of viral, bacterial or uncontrolled fungal infection requiring intravenous drug infusion within 1 week prior to the first dose
- •Presence of chronic or acute active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, defined as HBV-5 test at screening indicating active infection (positive HBsAg and/or positive HBcAb) with HBV-DNA > ULN, or positive HCVAb and positive HCV-RNA, allowed for antiviral therapy.
研究组 & 干预措施
QLS2313
Experimental
干预措施: QLS2313 (Drug)
结局指标
主要结局
DLT, MTD, RPIbD, and RP2D
时间窗: to 2 years
To evaluate the tolerability and safety of subcutaneously administered QLS2313 for Injection in patients with hematological malignancies, and to determine the MTD, RPIbD, and RP2D.
次要结局
未报告次要终点
研究者
研究点 (1)
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