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

Study Overview
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Brief Summary
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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.

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

Conditions
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Minimal Residual Disease

Intervention / Treatment
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* Drug: QN-030a
* Drug: Cyclophosphamid
* Drug: Fludarabine
* Drug: Cytarabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |