AzTrials
AzTrials

Relapsed Adult AMLPhase 1NCT06307054

CLL-1 CAR-NK Cells for Relapsed/Refractory AML

A Phase 1 study testing anti-CLL-1 CAR NK cells in people with Relapsed Adult AML and Refractory AML, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is a single-arm, open-label, dose-escalation clinical trial aimed at exploring the safety, tolerability, and pharmacokinetic characteristics of the CLL-1 CAR NK cells, as well as providing preliminary observations on its efficacy in subjects with relapsed/refractory acute myeloid leukemia. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Relapsed Adult AML, Refractory AML
What is being tested?
anti-CLL-1 CAR NK cells
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
1 Apr 2024to 15 Mar 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-70 years, gender unrestricted;
  • Expected survival time exceeds 12 weeks;
  • ECOG score 0-2;
  • Meets the 2022 WHO criteria for acute myeloid leukemia and flow cytometry shows ≥70% expression of CLL1 in leukemia cells; or immunohistochemistry shows CLL1 expression ≥50% and meets the following criteria for relapse and refractory:
  • Relapse criteria: Bone marrow shows primitive cells ≥5% after hematological remission (excluding post-chemotherapy hematopoietic recovery); or at least two peripheral blood samples taken at least one week apart show primitive cells; or extramedullary lesions are present. Early relapse (relapse within 12 months after initial remission) patients can be directly included, while late relapse (relapse after 12 months of initial remission) patients must have undergone salvage chemotherapy according to standard protocols without achieving complete remission. Salvage treatment for all relapsed patients should include at least one course of targeted therapy without achieving remission. Patients who relapse after allogeneic hematopoietic stem cell transplantation, have no other effective treatment options, and have no active grade 2 or higher acute GVHD.
  • Refractory criteria: No complete remission after two courses of standard intensive chemotherapy based on the 3+7 regimen, and no complete remission after second-line salvage chemotherapy or treatment including targeted therapy; or no complete remission after one course of purine analog induction chemotherapy (such as FLAG-Ida, CLIA, or similar regimens), and no complete remission after salvage treatment or treatment including targeted therapy; or no complete remission after three cycles of low-intensity treatment based on HMA, including low-intensity regimens containing venetoclax; relapse within 12 months after remission (early relapse); patients for whom the original induction is ineffective after relapse.
Show all 11Show fewer
  • Able to establish the required venous access for collection, and no contraindications for leukapheresis;
  • Liver and kidney function, cardiac and pulmonary function meet the following requirements:
  • Creatinine clearance (calculated by Cockcroft-Gault formula) ≥ 60 mL/min or creatinine ≤ 2.5×ULN;
  • Ejection fraction >50%, no clinically significant electrocardiogram changes; baseline blood oxygen saturation >92%; total bilirubin ≤ 3×ULN; ALT and AST ≤ 3×ULN;
  • Able to understand and sign the informed consent form.

Who cannot join

  • Any of the following conditions disqualify a subject from participation in the trial:
  • Confirmed AML with PML-RARA fusion gene;
  • History of malignancies other than acute myeloid leukemia within 5 years before screening, except adequately treated carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin, or prostate cancer after radical surgery, or thyroid cancer after radical surgery;
  • Uncontrolled active bacterial, viral, or fungal infections requiring treatment; HBsAg or HBcAb positive, with peripheral blood HBV DNA ≥ lower limit of detection; HCV RNA positive in the presence of hepatitis C virus antibodies; positive TRUST test for syphilis; HIV antibody positive;
  • Significant organ (cardiovascular, pulmonary) dysfunction; active gastrointestinal bleeding within the past 3 months; uncontrolled hypertension or history of hypertensive crisis or hypertensive encephalopathy; significant history or evidence of major cardiovascular risk, including congestive heart failure, unstable angina, clinically significant arrhythmias (such as ventricular fibrillation, ventricular tachycardia, etc.); history of arterial thrombosis within the past 3 months (such as stroke, transient ischemic attack); symptomatic deep vein thrombosis within the past 6 months, history of pulmonary embolism, or history of coronary angioplasty, defibrillation, or any clinical significant complications or diseases that may pose a risk to the subject's safety or interfere with the study evaluation, procedures, or completion;
  • Any uncontrolled active disease that hinders participation in the trial;
Show all 16Show fewer
  • Active, uncontrolled central nervous system involvement, or a history of central nervous system disease requiring treatment (such as epilepsy);
  • Subjects receiving systemic corticosteroid therapy before screening and deemed by the investigator to require long-term systemic corticosteroid therapy during the study period (excluding inhalation or local use); and subjects who have received systemic corticosteroid therapy within 72 hours before cell infusion (excluding inhalation or local use);
  • Subjects who have used PD-1 or PD-L1 monoclonal antibodies within 3 months before enrollment
  • Pregnant or lactating women; and subjects planning to become pregnant within 1 year after infusion, during or after the treatment period;
  • Uncontrolled active infections (excluding simple urinary tract infections or upper respiratory tract infections);
  • Subjects who have received CAR-T therapy or other gene-modified cell therapy in the past;
  • Patients after allogeneic transplantation, with no significant acute or chronic GVHD, and have discontinued immunosuppressive drugs for at least 1 month;
  • Known allergy to any component of anti-CLL-1 CAR-NK cell infusion or chemotherapy regimen (cyclophosphamide and fludarabine);
  • Any situation deemed by the investigator to compromise the safety of the subject or interfere with the purpose of the study, or deemed unsuitable for participation by the investigator;
  • Afflicted with a condition that affects the ability to sign the informed consent form in writing or to comply with the study procedures; unwilling or unable to comply with the study requirements.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080

    Xianmin Song, MD, +86 21 63240090 ext. 3175, shongxm@139.com

    Xianmin Song, MD

    Recruiting

Other trials in China

About this study

Official title: The Safety and Efficacy for Anti-human CLL-1 CAR-NK Cells in Subjects With Relapsed/Refractory Acute Myeloid Leukemia

This study is a single-arm, open-label, dose-escalation clinical trial aimed at exploring the safety, tolerability, and pharmacokinetic characteristics of the CLL-1 CAR NK cells, as well as providing preliminary observations on its efficacy in subjects with relapsed/refractory acute myeloid leukemia.

Being tested
anti-CLL-1 CAR NK cells
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.

  • anti-CLL-1 CAR NK cellsDrug

    Eligible patients enrolled in the study after screening will receive lymphocyte collection(from the patient or a donor ) and receive single dose CLL-1 CAR NK cells infusion after a successful cell production. There are a total of four cell dose level:5×10^6 CAR-NK cells/kg,1×10^7CAR-NK cells/kg,2×10^7CAR-NK cells/kg,4×10^7CAR-NK cells/kg

Study groups in NCT06307054
Study groupRoleWhat they receive
Anti CLL-1 CAR NK cellsExperimentalNot described
Receives: Drug: anti-CLL-1 CAR NK cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AE

    Adverse events related to cell reinfusion (≥ Grade 3 treatment-related organ toxicity, laboratory tests, and Grade 4 hematologic toxicity, etc.);

    Measured: 14 days-28 days after infusion

  2. DLT

    Dose limited toxicity

    Measured: 14 days-28 days after infusion

Secondary outcomes (7)

  1. Peak Plasma Concentration (Cmax)

    PK parameters: the maximum concentration (Cmax) of anti-CLL-1 CAR-NK cells in peripheral blood after administration, time to reach maximum concentration (Tmax), and area under the curve

    Measured: 28 days after infusion

  2. PD

    PD parameters: content of T/NK cells in peripheral blood (detection includes CD3, CD4, CD7, CD8, CD16, CD56, CD25, FOXP3, etc.); plasma cytokine levels at various time points;

    Measured: Time points according to the study

  3. Complete response

    Complete response

    Measured: 28 days after infusion

  4. Duration of response (DOR)

    the time from the first assessment of CR or CRi or PR to the first assessment of disease progression or death for any reason

    Measured: 28 days after infusion

  5. Progression-free survival (PFS)

    the time from cell reinfusion to the first assessment of tumor progression, relapse, or death for any reason

    Measured: through study completion, an average of 2 years

  6. Overall survival (OS)

    the time from cell reinfusion to death for any reason

    Measured: through study completion, an average of 2 years

  7. Number of participants with treatment-related AEs as assessed by CTCAE v5.0

    Liver and kidney function

    Measured: through study completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2024
  2. Study start1 Apr 2024
  3. Primary completion15 Mar 2026 (estimated)
  4. Study completion15 Mar 2027 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06307054
Sponsor's protocol ID
SHSY-CAR-NK-AML01
Status last verified
Sep 2025
First submitted
28 Feb 2024
Last updated
30 Sep 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing anti-CLL-1 CAR NK cells in people with Relapsed Adult AML and Refractory AML, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine 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 11 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 30 Sep 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AE (time frame: 14 days-28 days after 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?

On the ClinicalTrials.gov record for NCT06307054.

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 30 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in