| Eligibility |
Inclusion Criteria:
1. Aged 2-70 years, gender is not limited;
2. Subjects diagnosed with AML 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) AML patients:
1. Patients who have failed two cycles of standard chemotherapy;
2. Relapse within 12 months after consolidation and intensification therapy after
complete remission (CR);
3. Relapse after 12 months but failed to respond to conventional treatment
4. two or more recurrences;
5. persistent extramedullary leukemia;
3. ECOG physical status level is 0 to 2;
4. Bone marrow sample must be LILRB4 positive(Flow Cytometry)
5. Major organs must meet the following criteria:
1. Liver function: Total bilirubin=1.5 times the upper limit of normal,ALT and AST=3
times the upper limit of normal,
2. Renal function:Creatinine=1.5 times the upper limit of normal (ULN) or creatinine
clearance rate =60ml/min,
3. Cardiac function:LVEF=50%,
4. 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.
Exclusion Criteria:
1. Received CAR-T therapy or other gene-modified cell therapy in the past or participated
in other clinical investigators within 1 month before screening;
2. Any of the following cardiovascular and cerebrovascular diseases occurred within 6
months before screening:
1. congestive heart failure(NYHA stage III),myocardial infarction,unstable angina
pectoris,congenital long QT syndrom,Anterior left block,coronary
angioplasty,stent implantation,Coronary/peripheral artery bypass
grafting,CVA,Transient ischemic attack or pulmonary embolism,Asymptomatic right
bundle branch block was allowed;
2. Serious arrhythmias requiring treatment (eg, sustained ventricular tachycardia,
ventricular fibrillation, torsades de pointes, etc.);
3. 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;
3. The subject is positive for hepatitis B surface antigen or HBV DNA is higher than the
detection limit of analysis method;Positive hepatitis C antibody or HCV RNA is higher
than the detection limit of the analytical method;The subjects were positive for
syphilis antibody;
4. The subject with known systemic lupus erythematosus, active or uncontrolled autoimmune
disease (such as Crohns disease, rheumatoid arthritis, autoimmune hemolytic anemia,
etc.), primary or secondary immunodeficiency (such as HIV infection or serious
infectious disease, etc.);
5. 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;
6. Subjects with current or previous history of central nervous system disease, such as
seizures, stroke, severe brain injury, aphasia, paralysis, dementia, Parkinson's
disease, mental illness, etc. or central nervous system leukemia (CNSL);
7. Subjects with a history of solid organ transplantation or hematopoietic stem cell
transplantation (HSCT) within 6 months prior to screening;
8. Subjects with aGVHD and cGVHD at screening;
9. Subjects who have had any of the following drugs or treatments within the specified
time period prior to apheresis:
1. Administered any immunosuppressant within 2 weeks prior to apheresis;
2. Received any chemotherapy within 2 weeks or 3 half-lives, whichever is shorter,
prior to apheresis;
3. 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);
10. Those with mental illness or history of drug abuse;
11. Pregnant or breastfeeding subjects;
12. The investigator believes that there are other factors that are not suitable for
inclusion or that affect subjects participating in or completing the study.
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