AML, AdultPhase 1NCT05665114
Natural Killer(NK) Cell Therapy in r/r AML
A Phase 1 study testing QN-030a, Cyclophosphamid and Fludarabine in people with AML, Adult, run by Zhejiang University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AML, Adult
- What is being tested?
- QN-030a, Cyclophosphamid and Fludarabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 24 Dec 2022to 24 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, 310003
He Huang, MD, 86-13605714822, hehuangyu@126.com
About this study
Official title: 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.
- Conditions
- AML, Adult
- Being tested
- QN-030a, Cyclophosphamid, Fludarabine, Cytarabine, VP-16
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QN-030aDrug
NK cell therapy
CyclophosphamidDrug
Lympho-conditioning Agent
FludarabineDrug
Lympho-conditioning Agent
CytarabineDrug
Lympho-conditioning Agent
VP-16Drug
Lympho-conditioning Agent
| Study group | Role | What they receive |
|---|---|---|
| QN-030a | Experimental | QN-030a in Adult subjects with r/r AML Receives: Drug: QN-030a; Drug: Cyclophosphamid; Drug: Fludarabine; Drug: Cytarabine; Drug: VP-16 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability]
Measured: Up to approximately 2 years after last dose of QN-030a
Incidence of dose adjustment or discontinuation due to NK cell toxicities
Measured: Up to approximately 2 years after last dose of QN-030a
Incidence of subjects with Dose Limiting Toxicities within each dose level cohort
Measured: 28 Days from first dose of QN-030a
Determine the Maximum tolerated dose (MTD) and RP2D
Measured: 28 Days from first dose of QN-030a
Secondary outcomes (7)
Overall Response Rate(ORR) of QN-030a in r/r AML
Proportion of subjects who achieve a CR, CRi, CRMRD-, MLFS, or PR, as determined by investigator.
Measured: Up to approximately 2 years after last dose of QN-030a
Relapse-free survival (RFS) of QN-030a in r/r AML
Measured: Up to approximately 2 years after last dose of QN-030a
Time to Response (TTR) of QN-030a in r/r AML
Measured: Up to approximately 2 years after last dose of QN-030a
Event-free survival (EFS) of QN-030a in r/r AML
Measured: Up to approximately 2 years after last dose of QN-030a
Overall Survival (OS) of QN-030a in r/r AML
Measured: Up to approximately 2 years after last dose of QN-030a
Determination of the pharmacokinetics (PK) of QN-030a cells in peripheral blood
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
Measured: Up to approximately 2 years after last dose of QN-030a
Evaluate the immunogenicity features of QN-030a
The Donor specific antibody (DSA) and T cell receptor (TCR) will be measured.
Measured: Up to approximately 2 years after last dose of QN-030a
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start24 Dec 2022 (estimated)
- Primary completion24 Dec 2023 (estimated)
- Study completion24 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML, AdultStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Qihan Biotech Co., Ltd.
- Responsible party
- Principal investigator, He Huang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665114
- Sponsor's protocol ID
- QN030aAL
- Status last verified
- Dec 2022
- First submitted
- 13 Dec 2022
- Last updated
- 3 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Efficacy of QN-030a in Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT05665114
- Acronym / sponsor ID
- QN030aAL
- Conditions
- AML, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Hangzhou Qihan Biotech Co., Ltd.
- Study start
- 24 Dec 2022 (estimated)
- Primary completion
- 24 Dec 2023 (estimated)
- Study completion
- 24 Dec 2025 (estimated)
- First posted
- 27 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QN-030a | Experimental | Drug: QN-030a, Drug: Cyclophosphamid, Drug: Fludarabine, Drug: Cytarabine, Drug: VP-16QN-030a in Adult subjects with r/r AML |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QN-030aNK cell therapy | Drug | QN-030a |
| CyclophosphamidLympho-conditioning Agent | Drug | QN-030a |
| FludarabineLympho-conditioning Agent | Drug | QN-030a |
| CytarabineLympho-conditioning Agent | Drug | QN-030a |
| VP-16Lympho-conditioning Agent | Drug | QN-030a |
Primary outcome
Incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 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
Incidence of subjects with Dose Limiting Toxicities within each dose level cohort
Time frame: 28 Days from first dose of QN-030a
Determine the Maximum tolerated dose (MTD) and RP2D
Time frame: 28 Days from first dose of QN-030a
7 secondary outcomes
Overall Response Rate(ORR) of QN-030a in r/r AML
Time frame: 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
Time to Response (TTR) of QN-030a in r/r AML
Time frame: 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
Overall Survival (OS) of QN-030a in r/r AML
Time frame: 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
Evaluate the immunogenicity features of QN-030a
Time frame: Up to approximately 2 years after last dose of QN-030a
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QN-030a, Cyclophosphamid and Fludarabine in people with AML, Adult, run by Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact He Huang, PhD (86-13605714822, hehuangyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: Up to approximately 2 years after last dose of QN-030a). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2023.