JY231 (JY231) Injection for the Treatment of B-cell Acute Lymphoblastic Leukemia (B-ALL)

Inclusion Criteria

• •1. up to 75 years (Child, Adult) , either sex；
• •2. Bone marrow cell morphology examination showed the proportion of primitive and immature lymphocytes in the bone marrow is \>5%, or the bone marrow MRD analysis comfirmed as B-ALL.
• •3. Flow cytometry or histology confirmed positive expression of cluster of differentiation 19 (CD19);
• •4. According to the researcher's assessment, the expected survival period is greater than 3 months;
• •5. Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 3;
• •6. The patient has good liver, kidney, heart, and lung functions: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal(ULN), which can be relaxed to ≤ 5 × ULN for patients with liver invasion; Total serum bilirubin \< 34 μ Mol/L; Creatinine clearance rate\>30 mL/min; Cardiac ejection fraction (EF) ≥ 40%, without pericardial effusion and significant arrhythmia; Indoor oxygen saturation (SpO2) ≥ 92%;
• •7. Peripheral blood lymphocyte absolute count: absolute lymphocyte count (ALC) ≥ 0.5E9/L, blood platelet (PLT) \> 30E9/L, Hb \> 80g/L, with a single venous access and no other contraindications for blood cell separation;
• •8. MRI examination showed no active malignant cells in the cerebrospinal fluid, no brain metastases, or no central nervous system leukemia;
• •9. Individuals with fertility must agree to the use of efficient contraceptive methods;
• •10. The subject or their legal guardian can understand and voluntarily sign a written informed consent form.