- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05665114
Natural Killer(NK) Cell Therapy in r/r AML
December 29, 2022 updated by: He Huang, Zhejiang University
Clinical Study on the Safety and Efficacy of QN-030a in Acute Myeloid Leukemia
This is an open-label, Phase I study of QN-030a (allogeneic NK cell therapy) in relapse/refractory Acute Myeloid Leukemia (AML).
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
18
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yongxian Hu, PhD
- Phone Number: +8615957162012
- Email: huyongxian2000@aliyun.com
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310003
- Recruiting
- The first affiliated hospital of medical college of zhejiang university
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Key Inclusion Criteria:
- Provision of signed and dated informed consent form (ICF)
- ≥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
Key Exclusion Criteria:
- Allergic to drug used in this study
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: QN-030a
QN-030a in Adult subjects with r/r AML
|
NK cell therapy
Lympho-conditioning Agent
Lympho-conditioning Agent
Lympho-conditioning Agent
Lympho-conditioning Agent
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of subjects with Dose Limiting Toxicities within each dose level cohort
Time Frame: 28 Days from first dose of QN-030a
|
28 Days from first dose of QN-030a
|
Incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: Up to approximately 2 years after last dose of QN-030a
|
Up to approximately 2 years after last dose of QN-030a
|
Incidence of dose adjustment or discontinuation due to NK cell toxicities
Time Frame: Up to approximately 2 years after last dose of QN-030a
|
Up to approximately 2 years after last dose of QN-030a
|
Determine the Maximum tolerated dose (MTD) and RP2D
Time Frame: 28 Days from first dose of QN-030a
|
28 Days from first dose of QN-030a
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate(ORR) of QN-030a in r/r AML
Time Frame: Up to approximately 2 years after last dose of QN-030a
|
Proportion of subjects who achieve a CR, CRi, CRMRD-, MLFS, or PR, as determined by investigator.
|
Up to approximately 2 years after last dose of QN-030a
|
Relapse-free survival (RFS) of QN-030a in r/r AML
Time Frame: Up to approximately 2 years after last dose of QN-030a
|
Up to approximately 2 years after last dose of QN-030a
|
|
Time to Response (TTR) of QN-030a in r/r AML
Time Frame: Up to approximately 2 years after last dose of QN-030a
|
Up to approximately 2 years after last dose of QN-030a
|
|
Event-free survival (EFS) of QN-030a in r/r AML
Time Frame: Up to approximately 2 years after last dose of QN-030a
|
Up to approximately 2 years after last dose of QN-030a
|
|
Overall Survival (OS) of QN-030a in r/r AML
Time Frame: Up to approximately 2 years after last dose of QN-030a
|
Up to approximately 2 years after last dose of QN-030a
|
|
Determination of the pharmacokinetics (PK) of QN-030a cells in peripheral blood
Time Frame: Up to approximately 2 years after last dose of QN-030a
|
The 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
|
Evaluate the immunogenicity features of QN-030a
Time Frame: Up to approximately 2 years after last dose of QN-030a
|
The Donor specific antibody (DSA) and T cell receptor (TCR) will be measured.
|
Up to approximately 2 years after last dose of QN-030a
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 24, 2022
Primary Completion (Anticipated)
December 24, 2023
Study Completion (Anticipated)
December 24, 2025
Study Registration Dates
First Submitted
December 13, 2022
First Submitted That Met QC Criteria
December 23, 2022
First Posted (Actual)
December 27, 2022
Study Record Updates
Last Update Posted (Estimate)
January 2, 2023
Last Update Submitted That Met QC Criteria
December 29, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Cyclophosphamide
- Fludarabine
- Cytarabine
Other Study ID Numbers
- QN030aAL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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