Novel Anti-CD19 Universal CAR-T Cells for r/r CD19+ B-ALL

Exclusion Criteria

• •1. Presence of other concurrent active malignancy;
• •2. People with severe mental disorders;
• •3. A history of any of the following genetic disorders, such as Fanconi anemia, Schu-Day syndrome, Gerstmann syndrome, or any other known bone marrow failure syndrome;
• •4. Acute GVHD of grade II-IV or extensive chronic GVHD;
• •5. Had grade III-IV heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other clinically prominent heart disease within one year prior to enrollment;
• •6. The presence of any indwelling catheter or drainage (e.g., percutaneous nephrostomy, indwelling catheter, bile drainage, or pleural/peritoneal/pericardial catheter), except for patients who are permitted to use dedicated central venous catheters;
• •7. A history or disease of the central nervous system(CNS), such as seizure disease, cerebrovascular ischemia/bleeding, dementia, cerebellar disease, or any autoimmune disease involving the CNS;
• •8. Human immunodeficiency virus (HIV) seropositivity; Hepatitis B surface antigen positive or hepatitis B core antibody positive, and HBV-DNA positive; Patients with hepatitis C (HCV-RNA quantitative test results positive); Or the presence of other serious active viral or bacterial infections or uncontrolled systemic fungal infections;
• •9. Patients with severe history of allergy or allergic constitution;
• •10. A history of autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) leading to end-organ damage or requiring systemic immunosuppressive/systemic disease modulating drugs within the past 2 years;
• •11. Had or is suffering from interstitial lung disease (e.g., pneumonia, pulmonary fibrosis);
• •12. Had undergone other clinical trials in the 4 weeks prior to participating in this trial;
• •13. Poor compliance due to physiological, family, social, geographical and other factors, unable to cooperate with the study protocol and follow-up plan;
• •14. For patients contraindicated with cyclophosphamide and fludarabine chemotherapy;
• •15. Subjects requiring systemic corticosteroid therapy (prednisone ≥5mg/ day or equivalent dose of another corticosteroid) or other immunosuppressive agents within 1 month after UCAR-T cell reinfusion, except for adverse events;
• •16. Receiving donor lymphocyte infusion within 6 weeks before enrollment;
• •17. Pregnant and lactating women;
• •18. Any other condition that the investigator deemed inappropriate for inclusion.