Safety and Efficacy of ThisCART19A Bridging Hematopoietic Stem Cell Transplantation in Patients With Refractory or Relapsed B-cell Acute Lymphoblastic Leukemia

Exclusion Criteria

• •1. Allergic to preconditioning measures;
• •2. Diagnosis of chronic myelogenous leukemia lymphoid blast crisis;
• •3. Isolated extramedullary relapse;
• •4. Presence of CNS-3 disease or CNS-2 disease with neurological changes;
• •5. Imaging confirmed the presence of central nervous system involvement;
• •6. Severe CNS disorders such as a history of frequent epileptic seizures;
• •7. Patients with other malignancies other than B-cell malignancies within 5 years prior to screening. Patients with cured skin squamous carcinoma, basal carcinoma, non-primary invasive bladder cancer, localized low-risk prostate cancer, in situ cervical/breast cancer can be recruited.
• •8. Uncontrollable bacterial, fungal and viral infection during screening;
• •9. Patients had pulmonary embolism (PE) and/or deep vein thrombosis (DVT) within 3 months prior to enrollment;
• •10. Had intolerant severe cardiovascular and cerebrovascular diseases and hereditary diseases prior to enrollment;
• •11. Radiation therapy within 2 weeks prior to lymphodepletion chemotherapy (\>30% bone marrow exposure);
• •12. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) or Human immunodeficiency virus (HIV) or Syphilis infection. HBV-DNA \< 2000 IU/mL can be enrolled, but should admitted to use anti-virus drugs such as entecavir, tenofovir, etc, and supervisory the relative indication during the treatment;
• •13. Vaccinated with influenza vaccine within 2 weeks prior to lymphodepleting chemotherapy (Severe Acute Respiratory Syndrome-Corona virus disease 19 can be included, inactivated, live/non-live adjuvant vaccinations allowed to be included) ;
• •14. Patients who are receiving Graft versus host disease Hepatitis(GvHD) treatment; Patients without GvHD and who had stopped immunosuppressive drugs for at least 1 month were eligible for inclusion;
• •15. Women who are in pregnant or lactating, and female subjects or partners who plan to be pregnant within 1 year after cell infusion. Male subjects who plan pregnancy within 1 year after infusion;
• •16. Any ineligibility conditions considered by the investigator that may increase the risk of the subject or interfere with the results of the study.