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Acute Myelogenous LeukemiaNCT05739409

LILRB4 STAR-T Cell Therapy for Monocytic Leukemia

A study testing LILRB4 STAR-T cells injection in people with Acute Myelogenous Leukemia and Chronic Myelomonocytic Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single-center,single-arm,open-label phase I clinical study to determine the safety and efficacy of LILRB4 STAR-T cells in Monocytic Leukemia subjects. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
LILRB4 STAR-T cells injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
2 sitesChina
Study dates
16 Feb 2023to 9 May 2023
Phase
Interventional
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • -
  • 1. Aged 18-70 years, gender is not limited 2. Acute myelogenous leukemia or chronic monocytic leukemia:
  • Subjects diagnosed with acute myelogenous leukemia according to WHO 2016 criteria and according to the "Chinese Guidelines for the Diagnosis and Treatment of Relapsed and Refractory Acute Myeloid Leukemia (2021 Edition)" should meet any of the following relapsed and refractory (R/R) acute myelogenous leukemia patients:
  • Patients who have failed two cycles of standard chemotherapy;
  • No remission was achieved after 1 cycle of the standard regimen and could not continue with the standard regimen due to age, comorbidities, physical status, and / or adverse risk factors;
  • Relapse within 12 months after consolidation and intensification therapy after complete remission (CR);
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  • Relapse after 12 months but failed to respond to conventional treatment;
  • two or more recurrences;
  • persistent extramedullary leukemia;
  • For age> 60 years: standard regimen chemotherapy due to age, comorbidities, physical status, and / or adverse risk factors, and treated with 4 cycles of demethylating drugs (such as decitabine and / or azacitidine) or 2 cycles of low-dose chemotherapy ± demethylating drugs。 Note: Definition of relapse: reoccurrence of leukemic cells in peripheral blood after CR or in bone marrow> 5% (except for other causes such as marrow regeneration after consolidation chemotherapy) or extramedullary infiltration of leukemic cells.
  • Chronic granule-monocytic leukemia (CMML) type 2 was diagnosed according to the World Health Organization (WHO) 2016 Hematopoietic and Lymphoid Tissue tumors and the Chinese Guidelines for the Diagnosis and Treatment of Chronic Grain-Monocytic Leukemia (2021 edition), and did not achieve remission after at least one treatment or relapsed after remission。 3. Eastern Cooperative Oncology Group physical status level is 0 to 2; 4. Bone marrow sample must be LILRB4 positive； 5. Major organs must meet the following criteria:
  • Liver function: Total bilirubin≤1.5 times the upper limit of normal,glutamic-pyruvic transaminase and glutamic oxalacetic transaminase≤3 times the upper limit of normal,
  • Renal function:Creatinine≤1.5 times the upper limit of normal (ULN) or creatinine clearance rate ≥60ml/min,
  • Cardiac function:LVEF≥50%，
  • Lung function:Defined as ≤grade 1 dyspnea and blood oxygen saturation >92%; 6. Female subjects of reproductive age or male subjects whose partners are women of reproductive age agree to use an effective method of contraception throughout the trial and for 12 months after cell infusion; 7. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.

Who cannot join

  • Patients who have used chimeric antigen receptor T-cell immunotherapy therapy or any other gene transduction product within 3 months of signing the informed consent, except without detectable chimeric antigen receptor T-cell ratio or chimeric antigen receptor T-cell ratio below the lower test limit; or patients who have participated in other interventional clinical studies within 4 weeks prior to signing the informed consent；
  • Any of the following cardiovascular and cerebrovascular diseases occurred within 6 months before screening:
  • congestive heart failure(NYHA stage III),myocardial infarction,unstable angina pectoris,congenital long QT syndrome,Anterior left block,coronary angioplasty,stent implantation,Coronary/peripheral artery bypass grafting,cerebrovascular accident,Transient ischemic attack or pulmonary embolism,Asymptomatic right bundle branch block was allowed;
  • Serious arrhythmias requiring treatment (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes, etc.);
  • uncontrolled hypertension (systolic blood pressure greater than 160 mmHg and/or diastolic blood pressure greater than 100 mmHg), a history of hypertensive crisis or hypertensive encephalopathy;
  • Subjects with positive hepatitis B surface antigen (HBsAg) or positive hepatitis B core antibody (HBcAb) and hepatitis B virus DNA copy number above the detection limit; subjects with positive hepatitis C virus (HCV) antibody and positive HCV RNA copy number above the detection limit; positive pallidum antibody test；
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  • Patients with known systemic lupus erythematosus, combined active or uncontrolled autoimmune diseases (such as Crohns disease, rheumatoid arthritis, autoimmune hemolytic anemia, etc.), primary or secondary immune deficiency (such as HIV infection or severe infectious diseases, etc.)；
  • Previous or concurrent other incurable malignancies with unstable control,Affect the long-term survival of subjects, except for cured cervical carcinoma in situ, non-invasive basal cell or squamous cell skin cancer or other local prostate cancer after radical treatment, ductal carcinoma in situ after radical resection and at least 5 Years without recurrence of malignant tumor;
  • Patients with current disease or a previous history of central nervous system disease, such as seizures, stroke, severe brain injury, aphasia, paralysis, dementia, Parkinson's disease, mental illness, etc；
  • Patients living with an active central nervous system leukemia (CNSL)；
  • Patients who had prior solid organ transplantation or allogeneic hematopoietic stem cell transplantation (allo-HSCT) 6 months before screening；
  • Subjects with aGVHD and cGVHD at screening；
  • Subjects who have had any of the following drugs or treatments within the specified time period prior to apheresis:
  • Administered any immunosuppressant within 2 weeks prior to apheresis;
  • Received any chemotherapy within 2 weeks or 3 half-lives, whichever is shorter, prior to apheresis;
  • Received any macromolecule or small molecule targeted therapy such as monoclonal antibody, antibody-drug conjugate (ADC), double antibody, etc. within 4 weeks before apheresis or within 3 half-lives (whichever is shorter);
  • Those with mental illness or history of drug abuse;
  • Pregnant or breastfeeding subjects;
  • The investigator believes that there are other factors that are not suitable for inclusion or that affect subjects participating in or completing the study.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, Tianjin Municipality

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, 300020

Other trials in China

About this study

Official title: An Exploratory Clinical Study on the Safety and Efficacy of LILRB4 STAR-T Cells in the Treatment of Monocytic Leukemia

This is a single-center,single-arm,open-label phase I clinical study to determine the safety and efficacy of LILRB4 STAR-T cells in Monocytic Leukemia subjects.

Read the detailed description

This study will recruit LILRB4-positive monocytic leukemia subjects who will receive cyclophosphamide and fludarabine on days -5 to -3 prior to cell infusion, followed by LILRB4 STAR-T cells. The primary objective of the study was to evaluate the safety and tolerability of LILRB4 STAR-T cells in subjects with monocytic leukemia. The secondary objective was to evaluate the therapeutic efficacy, pharmacodynamics and pharmacokinetics of LILRB4 STAR-T cells.

Being tested
LILRB4 STAR-T cells injection
Medical subject headings
Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LILRB4 STAR-T cells injectionBiological

    The study population was relapsed/refractory acute myeloid leukemia and chronic myelomonocytic leukemia.Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of STAR-T cells. STAR-T cells will be intravenously infused with a escalated dose of 1E6#3E6#6E6#1E7 cells/kg

Study groups in NCT05739409
Study groupRoleWhat they receive
LILRB4 STAR-T cells injectionExperimentalThe study was divided into two phases: dose climbing and dose extension. Dose climbing stage: adopt the 3 + 3 dose climbing design principle, and the dose group is set as follows, in which, dose group-A is the backup dose reduction dose group, and dose group A is the starting dose: Dose Group-A: 3×105STAR+T cells / kg； Dose group A: 1×106STAR+T cells / kg； Dose group B: 3×106STAR+T cells / kg； Dose group C: 6×106STAR+T cells / kg； Dose group D: 1×107STAR+T cells / kg。
Receives: Biological: LILRB4 STAR-T cells injection

What is being measured

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

  1. Evaluate safety and tolerability

    Subjects are observed for dose-limiting toxicity(DLT) after LILRB4 STAR-T cells infusion, with the recording of adverse events(AE) and serious adverse events(SAE), with a focus on cytokine release syndrome(CRS) and immune cell-associated neurotoxicity(ICANS).All of the AE ratings were assessed according to the CTCAE.

    Measured: 12 months

Secondary outcomes (1)

  1. Antitumor efficacy

    After infusion of LILRB4 STAR-T cells, the subjects underwent bone marrow puncture every month to evaluate the tumor load in the bone marrow. The efficacy evaluation included complete morphological remission, complete remission with incomplete recovery of blood cytology, and partial remission.

    Measured: 12 months

Timeline

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

  1. First posted22 Feb 2023
  2. Study start16 Feb 2023
  3. Primary completion9 May 2023
  4. Study completion9 May 2023

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05739409
Sponsor's protocol ID
IIT2022069
Status last verified
May 2024
First submitted
12 Feb 2023
Last updated
11 Feb 2026
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 study testing LILRB4 STAR-T cells injection in people with Acute Myelogenous Leukemia and Chronic Myelomonocytic Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 2 sites 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 15 inclusion and 19 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: finished, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate safety and tolerability (time frame: 12 months). 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 NCT05739409.

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 11 Feb 2026.

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