Back to resultsNatural Killer(NK) Cell Therapy for AML Minimal Residual Disease
Primary Purpose
Minimal Residual Disease
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
QN-030a
Cyclophosphamid
Fludarabine
Cytarabine
Sponsored by
About this trial
This is an interventional treatment trial for Minimal Residual Disease
Eligibility Criteria
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
Sites / Locations
- Institute of Hematology & Blood Diseases HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
QN-030a
Arm Description
QN-030a in Adult subjects with MRD
Outcomes
Primary Outcome Measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of subjects with Dose Limiting Toxicities within each dose level cohort
Secondary Outcome Measures
Number of participants achieving MRD-
Relapse-free survival (RFS) of participants
Overall survival (OS) of participants
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
Full Information
NCT ID
NCT05601830
First Posted
October 24, 2022
Last Updated
November 3, 2022
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT05601830
Brief Title
Natural Killer(NK) Cell Therapy for AML Minimal Residual Disease
Official Title
Clinical Study on the Safety and Efficacy of QN-030a in Acute Myeloid Leukemia With Minimal Residual Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 28, 2022 (Anticipated)
Primary Completion Date
October 21, 2025 (Anticipated)
Study Completion Date
October 21, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Hematology & Blood Diseases Hospital, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Minimal Residual Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
QN-030a
Arm Type
Experimental
Arm Description
QN-030a in Adult subjects with MRD
Intervention Type
Drug
Intervention Name(s)
QN-030a
Intervention Description
NK cell therapy
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamid
Intervention Description
Lympho-conditioning Agent
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
Lympho-conditioning Agent
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Intervention Description
Lympho-conditioning Agent
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame
28 Days from first dose of QN-030a
Title
Incidence of subjects with Dose Limiting Toxicities within each dose level cohort
Time Frame
28 Days from first dose of QN-030a
Secondary Outcome Measure Information:
Title
Number of participants achieving MRD-
Time Frame
28 Days from first dose of QN-030a
Title
Relapse-free survival (RFS) of participants
Time Frame
Up to approximately 2 years after last dose of QN-030a
Title
Overall survival (OS) of participants
Time Frame
Up to approximately 2 years after last dose of QN-030a
Title
Determination of the pharmacokinetics (PK) of QN-030a cells in peripheral blood
Description
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
Time Frame
Up to approximately 2 years after last dose of QN-030a
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianxiang Wang
Phone
022-23909120
Email
wangjx@ihcams.ac.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Wang, Dr.
Phone
86-22-23909278
Email
wangying1@ihcams.ac.cn
Facility Information:
Facility Name
Institute of Hematology & Blood Diseases Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Jianxiang
Phone
022-23909120
Email
wangjx@ihcams.ac.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Natural Killer(NK) Cell Therapy for AML Minimal Residual Disease
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