Clinical Study of LILRA6 CAR-T for the Treatment of R/R Acute Myeloid Leukemia

Inclusion Criteria12

• Voluntarily participate in this study and sign the informed consent form.
• Age range: 18 - 75 years old. Gender is not restricted.
• Refractory/Recurrent AML: Meeting any one of the following criteria for refractory or recurrent cases is sufficient. 1) Refractory: (1) In the case of a newly diagnosed patient, treatment with the standard regimen for two courses fails to achieve complete remission (CR); (2) Recurrence within 12 months after consolidation and intensification therapy following CR; (3) Recurrence after 12 months with no response to salvage chemotherapy; (4) ≥ 2 recurrences; (5) Persistent extramedullary leukemia; 2) Recurrence: (1) Leukemia cells reappear in the peripheral blood after complete remission (CR) of AML; (2) The percentage of blasts in the bone marrow is ≥ 5% (excluding other reasons such as bone marrow regeneration after consolidation chemotherapy); (3) Infiltration of leukemia cells in sites other than the bone marrow (excluding the central nervous system).
• Expected survival period ≥ 12 weeks.
• The positive rate of LILRA6 expression in bone marrow/tumor cells is ≥ 20%
• ECOG score ranging from 0 to 2 points.
• Sufficient organ function reserve: Alanine aminotransferase and Aspartate aminotransferase ≤ 2.5× UNL (upper limit of normal value); Creatinine clearance rate (Cockcroft-Gault method) ≥ 45 mL/min; Serum total bilirubin ≤ 1.5× UNL; Ejection fraction of the heart (EF) ≥ 45%; In an indoor natural air environment, baseline oxygen saturation \> 92%; Blood routine: All of the following criteria are met: Absolute number of neutrophils ≥ 0.5×10\^9 /L, Platelet count ≥ 30×10\^9 /L, Hemoglobin ≥ 7.0 g/dl.
• Allow those who have previously undergone a single autologous hematopoietic stem cell transplantationAllowing previous recipients of a single autologous hematopoietic stem cell transplantation.
• Pregnancy tests for the female subjects of childbearing age must be negative, and they must also agree to take effective contraceptive measures during the trial.
• There are no uncontrollable infectious activities (including lung infections).
• Distance from the last anti-tumor treatment: Systemic chemotherapy / systemic radiotherapy / immunotherapy ≥ 3 weeks, targeted drug elution period ≥ 2 weeks.
• No active infection of the novel coronavirus or influenza.