Natural Killer(NK) Cell Therapy for AML Minimal Residual Disease

Phase 1

Terminated

• Conditions: Minimal Residual Disease
• Interventions: Drug: QN-030a; Drug: Cyclophosphamid; Drug: Fludarabine; Drug: Cytarabine

• Registration Number: NCT05601830
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Brief Summary

This is an open-label, Phase I study of QN-030a (allogeneic NK cell therapy) in Acute Myeloid Leukemia Minimal Residual Disease(AML MRD).

This clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-020a in patients with AML MRD, 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: 2022-10-09
• Study First Submitted: 2022-10-24
• Study First Submitted QC: 2022-10-28
• Study First Posted: 2022-11-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Provision of signed and dated informed consent form(ICF)
• ≥18 years old
• Subject diagnosed of AML MRD.
• 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 drug within 2 weeks of day 0 (first QN-030a dose infusion)
• Prior allogeneic hematopoietic stem cell transplant (HSCT) within 6 months of Day 0, 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
• History of central nervous system (CNS) disease such as stroke, epilepsy.
• Females are pregnant or lactating
• Known HIV infection, active Hepatitis B (HBV) or Hepatitis C (HCV) infection
• 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-030a	Cyclophosphamid	QN-030a in Adult subjects with MRD
QN-030a	Fludarabine	QN-030a in Adult subjects with MRD
QN-030a	QN-030a	QN-030a in Adult subjects with MRD
QN-030a	Cytarabine	QN-030a in Adult subjects with MRD

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	28 Days from first dose of QN-030a
Incidence of subjects with Dose Limiting Toxicities within each dose level cohort	28 Days from first dose of QN-030a

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS) of participants	Up to approximately 2 years after last dose of QN-030a
Relapse-free survival (RFS) of participants	Up to approximately 2 years after last dose of QN-030a
Determination of the pharmacokinetics (PK) of QN-030a cells in peripheral blood	Up to approximately 2 years after last dose of QN-030a	he 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
Number of participants achieving MRD-	28 Days from first dose of QN-030a

Trial Locations

Locations (1)

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