LILRB4 STAR-T Cell Therapy for Monocytic Leukemia

Exclusion Criteria

• •1. 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；
• •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 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;
• •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. 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；
• •4. 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.)；
• •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. 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；
• •7. Patients living with an active central nervous system leukemia (CNSL)；
• •8. Patients who had prior solid organ transplantation or allogeneic hematopoietic stem cell transplantation (allo-HSCT) 6 months before screening；
• •9. Subjects with aGVHD and cGVHD at screening；
• •10. 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);
• •11. Those with mental illness or history of drug abuse;
• •12. Pregnant or breastfeeding subjects;
• •13. The investigator believes that there are other factors that are not suitable for inclusion or that affect subjects participating in or completing the study.