Natural Killer (NK) Cell Therapy Targeting CD33 in Acute Myeloid Leukemia
AML, Adult
About this trial
This is an interventional treatment trial for AML, Adult
Eligibility Criteria
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 drugs/therapies 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) 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
Sites / Locations
- The first affiliated hospital of medical college of zhejiang universityRecruiting
Arms of the Study
Arm 1
Experimental
QN-023a
QN-023a in adult subjects with r/r AML