Overview
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.
Eligibility
Key Inclusion Criteria:
- 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
Key Exclusion Criteria:
- 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