Clinical Study on the Safety and Efficacy of QN-030a in Acute Myeloid Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Incidence of subjects with Dose Limiting Toxicities within each dose level cohort
研究概览
简要总结
This is an open-label, Phase I study of QN-030a (allogeneic NK cell therapy) in relapse/refractory Acute Myeloid Leukemia (AML).
This clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-030a in patients with r/r 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
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- •Adequate organ function as defined in the protocol
- •Donor specific antibody (DSA) to QN-030a: MFI <= 2000
排除标准
- •Allergic to drug used in this study
- •Accept other anti-tumor drugs/therapies within certain time of day 0 (first QN-030a 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)
- •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-030a
QN-030a in Adult subjects with r/r AML
干预措施: QN-030a (Drug)
QN-030a
QN-030a in Adult subjects with r/r AML
干预措施: Cyclophosphamid (Drug)
QN-030a
QN-030a in Adult subjects with r/r AML
干预措施: Fludarabine (Drug)
QN-030a
QN-030a in Adult subjects with r/r AML
干预措施: Cytarabine (Drug)
QN-030a
QN-030a in Adult subjects with r/r AML
干预措施: VP-16 (Drug)
结局指标
主要结局
Incidence of subjects with Dose Limiting Toxicities within each dose level cohort
时间窗: 28 Days from first dose of QN-030a
Determine the Maximum tolerated dose (MTD) and RP2D
时间窗: 28 Days from first dose of QN-030a
Incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: Up to approximately 2 years after last dose of QN-030a
Incidence of dose adjustment or discontinuation due to NK cell toxicities
时间窗: Up to approximately 2 years after last dose of QN-030a
次要结局
- Overall Response Rate(ORR) of QN-030a in r/r AML(Up to approximately 2 years after last dose of QN-030a)
- Time to Response (TTR) of QN-030a in r/r AML(Up to approximately 2 years after last dose of QN-030a)
- Determination of the pharmacokinetics (PK) of QN-030a cells in peripheral blood(Up to approximately 2 years after last dose of QN-030a)
- Relapse-free survival (RFS) of QN-030a in r/r AML(Up to approximately 2 years after last dose of QN-030a)
- Overall Survival (OS) of QN-030a in r/r AML(Up to approximately 2 years after last dose of QN-030a)
- Event-free survival (EFS) of QN-030a in r/r AML(Up to approximately 2 years after last dose of QN-030a)
- Evaluate the immunogenicity features of QN-030a(Up to approximately 2 years after last dose of QN-030a)
研究者
He Huang
Dr.
Zhejiang University