Natural Killer(NK) Cell Therapy for Acute Myeloid Leukemia
NCT ID: NCT05601466
Last Updated: 2024-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
3 participants
INTERVENTIONAL
2022-03-26
2023-04-11
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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QN-023a
QN-023a in adult subjects with r/r AML
QN-023a
NK cell therapy
Cyclophosphamid
Lympho-conditioning Agent
Fludarabine
Lympho-conditioning Agent
Cytarabine
Lympho-conditioning Agent
Interventions
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QN-023a
NK cell therapy
Cyclophosphamid
Lympho-conditioning Agent
Fludarabine
Lympho-conditioning Agent
Cytarabine
Lympho-conditioning Agent
Eligibility Criteria
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Inclusion Criteria
* ≥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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Hangzhou Qihan Biotech Co.,Ltd.
INDUSTRY
Institute of Hematology & Blood Diseases Hospital, China
OTHER
Responsible Party
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Locations
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Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
Countries
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Other Identifiers
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IIT2022029
Identifier Type: -
Identifier Source: org_study_id
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