Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
NCT ID:
NCT05601466
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 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05601466
Study Brief:
Protocol Section:
NCT05601466