Natural Killer(NK) Cell Therapy for Acute Myeloid Leukemia

AML, Adult Clinical Trial

Official title:

Clinical Study on QN-023a Targeting CD33 in Relapsed/Refractory Acute Myeloid Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05601466
• Other study ID #: QN023aTXM1
• Status: Recruiting
• Phase: Phase 1
• Start date: October 28, 2022
• Est. completion date: October 21, 2025

Study information

• Verified date: November 2022
• Source: Institute of Hematology & Blood Diseases Hospital
• Contact: Jianxiang Wang
• Phone: 022-23909120
• Email: wangjx[@]ihcams.ac.cn
• Is FDA regulated: No
• 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 18 patients will be enrolled.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• AML, Adult
• Leukemia, Myeloid, Acute

Intervention

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

Locations

Country	Name	City	State
China	Institute of Hematology & Blood Diseases Hospital	Tianjin	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Hematology & Blood Diseases Hospital	Hangzhou Qihan Biotech Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

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