A Clinical Study Exploring the Safety, Efficacy and Cell Metabolic Kinetics of Universal Car-t Cell Injection in CD19 and / or CD20 Positive Relapsed / Refractory B-cell Acute Lymphoblastic Leukemia in Adolescents, Children and Adults

Exclusion Criteria30

• pregnant or lactating women;
• there is HIV, syphilis infection, active hepatitis B virus infection (HBV-DNA is higher than the detection limit), or active hepatitis C virus infection (both HCV antibody and HCV-RNA are positive);
• there is currently any uncontrollable active infection, including but not limited to patients with active tuberculosis (judged by the investigator);
• there is active systemic autoimmune disease;
• patients with solitary extramedullary lesions;
• research participants with a history of neurological diseases, such as epilepsy, intracranial hemorrhage, severe brain injury, cerebellar disease, memory impairment, spinal cord compression or any disease involving the central nervous system, or suspected active central nervous system (CNS) metastasis;
• patients with bone marrow failure status related genetic syndromes: such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down syndrome were not excluded.
• for patients who relapsed after treatment with drugs targeting CD19 and / or CD20 before screening, the investigator judged that they could not benefit; 10. have received stem cell transplantation within 12 weeks before signing the informed consent; Received donor lymphocyte infusion (DLI) within 6 weeks;
• received the following treatments before cell infusion:
• Received anthracyclines, vinblastines, 6-mercaptopurine, 6-thioguanine, methotrexate, cytarabine, asparaginase, etc. within 7 days before infusion;
• Hydroxyurea and tyrosine kinase inhibitors were used within 3 days before infusion;
• Radiotherapy was used within 1 week before infusion (2 weeks interval for lung radiotherapy and 8 weeks interval for CNS radiotherapy);
• CNS prophylactic therapy (such as intrathecal injection of chemotherapeutic drugs) within 1 week before infusion;
• Give any T-cell lysis or antibody (such as alemtuzumab) within 8 weeks before infusion;
• Use monoclonal antibody, double antibody or ADC within 4 weeks before infusion;
• ;
• Received systemic glucocorticoids equivalent to \>15 mg/ day prednisone within 3 days before infusion, except for glucocorticoids used locally;
• Polyethylene glycol asparaginase was used within 4 weeks before infusion;
• have been vaccinated with live attenuated vaccine, inactivated vaccine or RNA vaccine within 4 weeks before signing the informed consent;
• those who are allergic or intolerant to Qinglin drugs and tocilizumab, or allergic to components (dimethyl sulfoxide /dmso) in ct1190b cell infusion preparations; Or previous history of other serious allergies such as anaphylactic shock;
• patients with any of the following cardiac diseases before screening:
• New York Heart Association (NYHA) class III or IV heart failure;
• ;
• A history of clinically significant uncontrolled arrhythmias, such as ventricular arrhythmias;
• A history of severe non ischemic cardiomyopathy;
• Other heart diseases that the investigator believes may endanger the health of the patient due to participation in this clinical study;
• serious lung disease may endanger the patient's life after participating in the study as judged by the investigator;
• there are second primary malignant tumors that need treatment or have not been completely relieved in the past 2 years, except the following successfully treated tumors with low malignancy such as non metastatic basal cell carcinoma or squamous cell skin carcinoma, non metastatic prostate cancer, breast cancer or cervical cancer in situ, non muscle invasive bladder cancer or thyroid cancer;
• major surgery within 2 weeks before signing the informed consent, or major surgery planned during the study or within 4 weeks after giving the study treatment (excluding cataract and other local anesthesia surgery);
• after organ transplantation;