Clinical Study on QN-023a Targeting CD33 in Relapsed/Refractory Acute Myeloid Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
研究概览
简要总结
This is an open-label, Phase I study of QN-023a (allogeneic CAR-NK cells targeting CD33) in relapsed/refractory Acute Myeloid Leukemia (AML).
The clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-023a in patients with relapsed/refractory AML,where a "3+3" enrollment schema will be utilized at dose escalation stage. Up to 18 patients will be enrolled.
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
- •Provision of signed and dated informed consent form (ICF)
- •≥18 years old
- •Diagnosis of r/r AML
- •Subjects with CD33 positive leukemia cells
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- •Adequate organ function as defined in the protocol
- •Donor specific antibody (DSA) to QN-023a: MFI <= 2000
排除标准
- •Allergic to drug used in this study
- •Accept other anti-tumor drug within certain time of day 0 (first QN-023a dose infusion), time window and drug defined in the protocol.
- •received systemic immunosuppressive therapy within 7 days of day 0, or likely to require systemic immunosuppressive therapy
- •Acute Promyelocytic Leukemia (APL)
- •Active central nervous system Leukemia.
- •Uncontrolled, active clinically significant infection
- •Clinically significant cardiovascular disease as defined in the protocol
- •Known HIV infection, active Hepatitis B (HBV) or Hepatitis C (HCV) infection
- •History of central nervous system (CNS) disease such as stroke, epilepsy.
- •Females are pregnant or lactating
- •Investigator-assessed presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to subject
研究组 & 干预措施
QN-023a
QN-023a in adult subjects with r/r AML
干预措施: QN-023a (Drug)
QN-023a
QN-023a in adult subjects with r/r AML
干预措施: Cyclophosphamid (Drug)
QN-023a
QN-023a in adult subjects with r/r AML
干预措施: Fludarabine (Drug)
QN-023a
QN-023a in adult subjects with r/r AML
干预措施: Cytarabine (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: 28 Days from first dose of QN-023a
The incidence of subjects with Dose Limiting Toxicities within each dose level cohort
时间窗: 28 Days from first dose of QN-023a
次要结局
- Overall Response Rate(ORR)(Up to approximately 2 years after last dose of QN-023a)
- Relapse-free survival (RFS) of participants(Up to approximately 2 years after last dose of QN-023a)
- Determination of the pharmacokinetics (PK) of QN-023a cells in peripheral blood(Up to approximately 2 years after last dose of QN-023a)