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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05665075
Other study ID # QN023aM
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date December 24, 2022
Est. completion date December 24, 2025

Study information

Verified date December 2022
Source Zhejiang University
Contact He Huang, PhD
Phone 86-13605714822
Email hehuangyu@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 19 patients will be enrolled.


Recruitment information / eligibility

Status Recruiting
Enrollment 19
Est. completion date December 24, 2025
Est. primary completion date December 24, 2023
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 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
QN-023a
NK cell therapy
Cyclophosphamid
Lympho-conditioning Agent
Fludarabine
Lympho-conditioning Agent
Cytarabine
Lympho-conditioning Agent
VP-16
Lympho-conditioning Agent

Locations

Country Name City State
China The first affiliated hospital of medical college of zhejiang university Hangzhou Zhejiang

Sponsors (2)

Lead Sponsor Collaborator
Zhejiang University Hangzhou Qihan Biotech Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence and severity of Treatment-Emergent Adverse Events[Safety and Tolerability] Up to approximately 2 years after last dose of QN-023a
Primary Incidence of dose adjustment or discontinuation due to NK cell toxicities Up to approximately 2 years after last dose of QN-023a
Primary Incidence of subjects with Dose Limiting Toxicities within each dose level cohort 28 Days from first dose of QN-023a
Primary Determine the maximum tolerated dose (MTD) and RP2D 28 Days from first dose of QN-023a
Secondary Overall Response Rate(ORR) of QN-023a in r/r AML Proportion of subjects who achieve a CR, CRi, CRMRD-, MLFS, or PR, as determined by investigator. Up to approximately 2 years after last dose of QN-023a
Secondary Relapse-free survival (RFS) of QN-023a in r/r AML Up to approximately 2 years after last dose of QN-023a
Secondary Time to Response (TTR) of QN-023a in r/r AML Up to approximately 2 years after last dose of QN-023a
Secondary Event-free survival (EFS) of QN-023a in r/r AML Up to approximately 2 years after last dose of QN-023a
Secondary Overall Survival (OS) of QN-023a in r/r AML 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
Secondary Evaluate the immunogenicity features of QN-023a The Donor specific antibody (DSA) and T cell receptor (TCR) will be measured. Up to approximately 2 years after last dose of QN-023a
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