Natural Killer(NK) Cell Therapy for Acute Myeloid Leukemia

Phase 1

Terminated

• Conditions: AML, Adult
• Interventions: Drug: QN-023a; Drug: Cyclophosphamid; Drug: Fludarabine; Drug: Cytarabine

• Registration Number: NCT05601466
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-26
• Study First Submitted: 2022-10-21
• Study First Submitted QC: 2022-10-28
• Study First Posted: 2022-11-01
• Primary Completion: 2023-04-11
• Study Completion: 2023-04-11
• Status Verified: 2024-05
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
QN-023a	Cytarabine	QN-023a in adult subjects with r/r AML
QN-023a	QN-023a	QN-023a in adult subjects with r/r AML
QN-023a	Fludarabine	QN-023a in adult subjects with r/r AML
QN-023a	Cyclophosphamid	QN-023a in adult subjects with r/r AML

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	28 Days from first dose of QN-023a
The incidence of subjects with Dose Limiting Toxicities within each dose level cohort	28 Days from first dose of QN-023a

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate(ORR)	Up to approximately 2 years after last dose of QN-023a
Relapse-free survival (RFS) of participants	Up to approximately 2 years after last dose of QN-023a
Determination of the pharmacokinetics (PK) of QN-023a cells in peripheral blood	Up to approximately 2 years after last dose of QN-023a	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

Trial Locations

Locations (1)

Institute of Hematology & Blood Diseases Hospital; 🇨🇳 Tianjin, Tianjin, China