AML, Adult Clinical Trial
Official title:
Clinical Study on QN-023a Targeting CD33 in Relapsed/Refractory Acute Myeloid Leukemia
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.
Status | Recruiting |
Enrollment | 18 |
Est. completion date | October 21, 2025 |
Est. primary completion date | October 21, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
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 |
Country | Name | City | State |
---|---|---|---|
China | Institute of Hematology & Blood Diseases Hospital | Tianjin | Tianjin |
Lead Sponsor | Collaborator |
---|---|
Institute of Hematology & Blood Diseases Hospital | Hangzhou Qihan Biotech Co.,Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 28 Days from first dose of QN-023a | ||
Primary | The incidence of subjects with Dose Limiting Toxicities within each dose level cohort | 28 Days from first dose of QN-023a | ||
Secondary | Overall Response Rate(ORR) | Up to approximately 2 years after last dose of QN-023a | ||
Secondary | Relapse-free survival (RFS) of participants | Up to approximately 2 years after last dose of QN-023a | ||
Secondary | Determination of the pharmacokinetics (PK) of QN-023a cells in peripheral blood | The PK of QN-023a in peripheral blood will be reported as the relative percentage of product (QN-023a) DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points | Up to approximately 2 years after last dose of QN-023a |
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