AML, AdultPhase 1NCT06027853
Natural Killer(NK) Cell Therapy Targeting CLL1 in Acute Myeloid Leukemia
A Phase 1 study testing CLL1 CAR-NK cell injection in people with AML, Adult, run by Zhejiang University at 1 site in China.
Trial summary
This is a phase 1, first-in-human (FIH), open-label, multicohort study to evaluate the safety, tolerability and preliminary efficacy of CLL1 target CAR iPSC NK cells in patients with relapsed/refractory AML 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?
- CLL1 CAR-NK cell injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2023to 31 Aug 2026
- 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
- ≥18 years old.
- Confirmed diagnosis of r/r AML
- CLL1 expression is positive in AML blasts.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1 and life expectancy greater than 12 weeks.
- Adequate organ and marrow function, as defined below:
- Blood creatinine (Cr) ≤ 2 x ULN or calculated creatinine clearance (Cockcroft- Gault formula) ≥ 50 mL/min;
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- Total bilirubin (TBIL) ≤ 2 x the ULN;
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN;
- International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN
- Females of childbearing potential must have a negative serum pregnancy test.
- Donor specific antibody (DSA) is negative: MFI <= 2000.
- Provision of signed and dated informed consent form (ICF).
Who cannot join
- Allergic to drug used in this study.
- Subjects received any antitumor therapy as follows, prior to first NK infusion:
- Systemic steroid therapy within 3 days (except physiological replacement therapy);
- Systemic antitumor therapy within 2 weeks or at least 5 half-lives, whichever is less;
- Radiotherapy within 4 weeks;
- Donor lymphocyte infusion within 6 weeks;
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- Intrathecal treatment within 1 week;
- CAR-T therapy, CAR-NK therapy, or any other genetically modified cell therapy product within 6 months;
- History of allogeneic stem cell transplantation.
- Received the vaccine within 4 weeks prior to the first infusion and/or expected to require vaccination from the study period to 12 weeks after the last infusion.
- Active central nervous system Leukemia.
- Acute Promyelocytic Leukemia (APL).
- History of other malignant tumors, except for those who have achieved complete remission more than 5 years after radical treatment without any signs of recurrence.
- Active autoimmune diseases.
- History of central nervous system disease or meningeal involvement such as epilepsy, paralysis, aphasia, stroke, etc.
- Serious cardiovascular and cerebrovascular diseases:
- Severe heart rhythm or conduction abnormalities, corrected QT interval (QTc)≥480 ms;
- Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events within 6 months prior to first infusion;
- New York Heart Association (NYHA) class II or above congestive heart failure or left ventricular ejection fraction (LVEF) <50% in color Doppler echocardiography;
- Hypertension that cannot be controlled by drug.
- Active pulmonary infection; SpO2 ≤90%; Pulmonary embolism, chronic obstructive pulmonary disease, or interstitial lung disease.
- Uncontrolled bacterial, fungal, or viral infection. Known HIV infection, active Hepatitis B (HBV) or Hepatitis C (HCV) infection.
- History of substance abuse.
- Toxicity induced by previous therapy not recovered to ≤ grade 2(NCI-CTCAE v5.0).
- Large surgical treatment within 4 weeks prior to first infusion, not including diagnostic biopsy.
- Pregnant/breastfeeding women.
- 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
Clinical research ethics committee of the first affiliated hospital, college of medicine, zhejiang University
Hangzhou, Zhejiang
He Huang, 0571-87233772, hehuang@zju.edu.cn
About this study
Official title: Clinical Study to Evaluate the Safety and Efficacy of iPSC NK Cells Targeting CLL1 in Patients With Relapsed/Refractory AML
This is a phase 1, first-in-human (FIH), open-label, multicohort study to evaluate the safety, tolerability and preliminary efficacy of CLL1 target CAR iPSC NK cells in patients with relapsed/refractory AML
Read the detailed description
Acute myelogenous leukemia (AML) is a potentially cur-able disease; 70% of newly diagnosed patients achievecomplete remission with first-line therapy, but prognosisworsens for relapsed disease in both pediatric and adultpatients. CLL-1 has attracted the researchers' attention due to its high expression in AML while being absent in normal hematopoietic stem cell. Accumulating evidence have demonstrated CLL-1 is an ideal target for AML.
- Conditions
- AML, Adult
- Being tested
- CLL1 CAR-NK cell injection
- 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.
CLL1 CAR-NK cell injectionDrug
Drug: CLL1 NK cell therapy Drug: Cyclophosphamid Lympho-conditioning Agent Drug: Fludarabine Lympho-conditioning Agent
Drug: VP-16 Lympho-conditioning Agent
| Study group | Role | What they receive |
|---|---|---|
| CAR-NK cell therapy in Adult subjects with r/r AML | Experimental | CAR-NK cell therapy in Adult subjects with r/r AML Receives: Drug: CLL1 CAR-NK cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Safety and Tolerability
Measured: 28 Days from first dose of iPSC NK cell infusion
Incidence of subjects with Dose Limiting Toxicities within each dose level cohort
Tolerability
Measured: 28 Days from first dose of iPSC NK cell infusion
Secondary outcomes (1)
Determination of the pharmacokinetics (PK) of iPSC NK cells in peripheral blood
The PK of iPSC NK in peripheral blood will be reported as the relative percentage of product DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points
Measured: Up to approximately 2 years after last dose of iPSC NK cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start10 Sep 2023 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Qihangene Biotech Co.,Ltd.
- Responsible party
- Principal investigator, He Huang, Zhejiang University
- Investigators
- He Huang, MD, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027853
- Sponsor's protocol ID
- QH-CLL1-01
- Status last verified
- Aug 2023
- First submitted
- 30 Aug 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Safety and Efficacy of iPSC NK Cells Targeting CLL1 in Patients With Relapsed/Refractory AML
- ClinicalTrials.gov ID
- NCT06027853
- Acronym / sponsor ID
- QH-CLL1-01
- Conditions
- AML, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Hangzhou Qihangene Biotech Co.,Ltd.
- Study start
- 10 Sep 2023 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 7 Sep 2023 (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 a phase 1, first-in-human (FIH), open-label, multicohort study to evaluate the safety, tolerability and preliminary efficacy of CLL1 target CAR iPSC NK cells in patients with relapsed/refractory AML
Detailed description
Acute myelogenous leukemia (AML) is a potentially cur-able disease; 70% of newly diagnosed patients achievecomplete remission with first-line therapy, but prognosisworsens for relapsed disease in both pediatric and adultpatients. CLL-1 has attracted the researchers' attention due to its high expression in AML while being absent in normal hematopoietic stem cell. Accumulating evidence have demonstrated CLL-1 is an ideal target for AML.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-NK cell therapy in Adult subjects with r/r AML | Experimental | Drug: CLL1 CAR-NK cell injectionCAR-NK cell therapy 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 (12 listed)
- ≥18 years old.
- Confirmed diagnosis of r/r AML
- CLL1 expression is positive in AML blasts.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1 and life expectancy greater than 12 weeks.
- Adequate organ and marrow function, as defined below:
Key exclusion criteria (27 listed)
- Allergic to drug used in this study.
- Subjects received any antitumor therapy as follows, prior to first NK infusion:
- History of allogeneic stem cell transplantation.
- Received the vaccine within 4 weeks prior to the first infusion and/or expected to require vaccination from the study period to 12 weeks after the last infusion.
- Active 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 |
|---|---|---|
| CLL1 CAR-NK cell injectionDrug: CLL1 NK cell therapy Drug: Cyclophosphamid Lympho-conditioning Agent Drug: Fludarabine Lympho-conditioning Agent Drug: VP-16 Lympho-conditioning Agent | Drug | CAR-NK cell therapy in Adult subjects with r/r AML |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 28 Days from first dose of iPSC NK cell infusion
Safety and Tolerability
Incidence of subjects with Dose Limiting Toxicities within each dose level cohort
Time frame: 28 Days from first dose of iPSC NK cell infusion
Tolerability
1 secondary outcome
Determination of the pharmacokinetics (PK) of iPSC NK cells in peripheral blood
Time frame: Up to approximately 2 years after last dose of iPSC NK cell infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: No
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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.
He Huang, MD principal investigator
First Affiliated Hospital of Zhejiang University
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 CLL1 CAR-NK cell injection 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 12 inclusion and 27 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 7 Sep 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, MD (+8613605714822, hehuangyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: 28 Days from first dose of iPSC NK cell infusion). The study lists 2 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 7 Sep 2023.