Natural Killer(NK) Cell Therapy in r/r AML

AML, Adult Clinical Trial

Official title:

Clinical Study on the Safety and Efficacy of QN-030a in Acute Myeloid Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05665114
• Other study ID #: QN030aAL
• Status: Recruiting
• Phase: Phase 1
• 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
• Study type: Interventional

Clinical Trial Summary

This is an open-label, Phase I study of QN-030a (allogeneic NK cell therapy) in relapse/refractory Acute Myeloid Leukemia (AML). This clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-030a in patients with r/r AML, where a "3+3" enrollment schema will be utilized at dose escalation stage. Up to 18 patients will be enrolled.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• 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
• Eastern Cooperative Oncology Group (ECOG) performance status =1
• Adequate organ function as defined in the protocol
• Donor specific antibody (DSA) to QN-030a: 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-030a 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

Related Conditions & MeSH terms

• AML, Adult

Intervention

Drug:
• QN-030a
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-030a
Primary	Incidence of dose adjustment or discontinuation due to NK cell toxicities		Up to approximately 2 years after last dose of QN-030a
Primary	Incidence of subjects with Dose Limiting Toxicities within each dose level cohort		28 Days from first dose of QN-030a
Primary	Determine the Maximum tolerated dose (MTD) and RP2D		28 Days from first dose of QN-030a
Secondary	Overall Response Rate(ORR) of QN-030a 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-030a
Secondary	Relapse-free survival (RFS) of QN-030a in r/r AML		Up to approximately 2 years after last dose of QN-030a
Secondary	Time to Response (TTR) of QN-030a in r/r AML		Up to approximately 2 years after last dose of QN-030a
Secondary	Event-free survival (EFS) of QN-030a in r/r AML		Up to approximately 2 years after last dose of QN-030a
Secondary	Overall Survival (OS) of QN-030a in r/r AML		Up to approximately 2 years after last dose of QN-030a
Secondary	Determination of the pharmacokinetics (PK) of QN-030a cells in peripheral blood	The PK of QN-030a in peripheral blood will be reported as the relative percentage of product (QN-030a) DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points	Up to approximately 2 years after last dose of QN-030a
Secondary	Evaluate the immunogenicity features of QN-030a	The Donor specific antibody (DSA) and T cell receptor (TCR) will be measured.	Up to approximately 2 years after last dose of QN-030a