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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RECRUITING
PHASE1
18 participants
INTERVENTIONAL
2022-12-24
2025-12-24
Brief Summary
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This clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-030a in patients with r/r 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-030a
QN-030a in Adult subjects with r/r AML
QN-030a
NK cell therapy
Cyclophosphamid
Lympho-conditioning Agent
Fludarabine
Lympho-conditioning Agent
Cytarabine
Lympho-conditioning Agent
VP-16
Lympho-conditioning Agent
Interventions
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QN-030a
NK cell therapy
Cyclophosphamid
Lympho-conditioning Agent
Fludarabine
Lympho-conditioning Agent
Cytarabine
Lympho-conditioning Agent
VP-16
Lympho-conditioning Agent
Eligibility Criteria
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Inclusion Criteria
* ≥18 years old
* Diagnosis of r/r AML
* 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
Exclusion Criteria
* Accept other anti-tumor drugs/therapies within certain time of day 0 (first QN-030a 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)
* 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
Zhejiang University
OTHER
Responsible Party
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He Huang
Dr.
Locations
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The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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QN030aAL
Identifier Type: -
Identifier Source: org_study_id
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