Back to resultsNatural Killer(NK) Cell Therapy for Acute Myeloid Leukemia
Primary Purpose
AML, Adult
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
QN-023a
Cyclophosphamid
Fludarabine
Cytarabine
Sponsored by
About this trial
This is an interventional treatment trial for AML, Adult
Eligibility Criteria
Key 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
Sites / Locations
- Institute of Hematology & Blood Diseases HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
QN-023a
Arm Description
QN-023a in adult subjects with r/r AML
Outcomes
Primary Outcome Measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The incidence of subjects with Dose Limiting Toxicities within each dose level cohort
Secondary Outcome Measures
Overall Response Rate(ORR)
Relapse-free survival (RFS) of participants
Determination of the pharmacokinetics (PK) of QN-023a cells in peripheral blood
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
Full Information
NCT ID
NCT05601466
First Posted
October 21, 2022
Last Updated
November 3, 2022
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Collaborators
Hangzhou Qihan Biotech Co.,Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05601466
Brief Title
Natural Killer(NK) Cell Therapy for Acute Myeloid Leukemia
Official Title
Clinical Study on QN-023a Targeting CD33 in Relapsed/Refractory Acute Myeloid Leukemia
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
Collaborators
Hangzhou Qihan Biotech Co.,Ltd.
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-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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AML, Adult
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-023a
Arm Type
Experimental
Arm Description
QN-023a in adult subjects with r/r AML
Intervention Type
Drug
Intervention Name(s)
QN-023a
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-023a
Title
The incidence of subjects with Dose Limiting Toxicities within each dose level cohort
Time Frame
28 Days from first dose of QN-023a
Secondary Outcome Measure Information:
Title
Overall Response Rate(ORR)
Time Frame
Up to approximately 2 years after last dose of QN-023a
Title
Relapse-free survival (RFS) of participants
Time Frame
Up to approximately 2 years after last dose of QN-023a
Title
Determination of the pharmacokinetics (PK) of QN-023a cells in peripheral blood
Description
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
Time Frame
Up to approximately 2 years after last dose of QN-023a
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
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
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
+862223909278
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
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Natural Killer(NK) Cell Therapy for Acute Myeloid Leukemia
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