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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Minimal Residual Disease
• Intervention / Treatment: Drug: QN-030a; Drug: Cyclophosphamid; Drug: Fludarabine; Drug: Cytarabine

• Study Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ying Wang, Dr.; Phone Number: 86-22-23909278; Email: wangying1@ihcams.ac.cn
• Study Contact Backup: Name: Jianxiang Wang; Phone Number: 022-23909120; Email: wangjx@ihcams.ac.cn

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • Institute of Hematology & Blood Diseases Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QN-030a; QN-030a in Adult subjects with MRD	Drug: QN-030a; NK cell therapy; Drug: Cyclophosphamid; Lympho-conditioning Agent; Drug: Fludarabine; Lympho-conditioning Agent; Drug: Cytarabine; Lympho-conditioning Agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Number of participants achieving MRD-		28 Days from first dose of QN-030a
Relapse-free survival (RFS) of participants		Up to approximately 2 years after last dose of QN-030a
Overall survival (OS) 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	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	Up to approximately 2 years after last dose of QN-030a

Collaborators and Investigators

• Sponsor: Institute of Hematology & Blood Diseases Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 28, 2022
• Primary Completion (Anticipated): October 21, 2025
• Study Completion (Anticipated): October 21, 2025

Study Registration Dates

• First Submitted: October 24, 2022
• First Submitted That Met QC Criteria: October 28, 2022
• First Posted (Actual): November 1, 2022

Study Record Updates

• Last Update Posted (Actual): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm, Residual; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Cyclophosphamide; Fludarabine; Cytarabine
• Other Study ID Numbers: QN030aTXM1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No