CD19 hsCAR-T for Refractory/Relapsed CD19+ B-ALL Patients

Exclusion Criteria

• •1. Patients with hypervolemia (white blood cell count\> 50 x 10\^9 / L) or rapidly progressive disease that in the estimation of the investigators and sponsors would compromise the patient's ability to complete the study;
• •2. History of melanoma skin cancer or other primary tumors (eg, cervical cancer, bladder cancer, breast cancer) (except for those with 3 years or longer of cure);
• •3. Patients with fungal, bacterial, viral, or other uncontrollable infections or infections requiring Level 4 isolation (UTI or inoculation assays may be performed if necessary);
• •4. Patients with positive results for HIV, HBV, HCV tests;
• •5. With CNS disorders such as cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or autoimmune disease with CNS involvement;
• •6. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac diseases within 12 months of enrollment, or with cardiac atrial or cardiac ventricular lymphoma;
• •7. Patients that are receiving anticoagulant therapy or have ever coagulation disorders;
• •8. Any medical condition that in the judgment of the sponsors/investigators is likely to interfere with assessment of safety or efficacy of study;
• •9. History of severe immediate hypersensitivity reaction to any of the agents used in this study;
• •10. Female patients who are pregnant or breastfeeding;
• •11. Feasibility assessment during screening demonstrates \<30% transduction of target lymphocytes, or insufficient expansion (\< 5-fold) in response to CD3/CD28 co-stimulation;
• •12. Patients with any uncontrolled diseases that are unsuitable for enrollment;
• •13. CNS3 disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity;
• •14. Any situation that is considered to potentially increase the risk of the subject or interfere with the outcome of the study;
• •15. Patients who have been enrolled in other clinical studies.