The purpose of the study is to evaluate the safety and tolerability of B019 in subjects.
The patient himself/herself , and/or his/her legal guardian, agree to participate in the trial and sign the informed consent form；
Meet the diagnostic criteria for recurrent or refractory acute B cell lymphoblastic leukemia；
Documentation of CD19/CD22 tumor expression
Active CNS involvement by malignancy；
Isolated extramedullary leukemia recurrence；
Subjects with ≥grade 2 acute or moderate to severe chronic graft-versus-host disease (GVHD) within 4 weeks prior to screening;
Has had treatment with any prior CAR-T therapy or other therapy abandoned in protocal.
Single group
B019
Biological/VaccineB019： Intravenous infusion, 1.0×10\^6 CAR T cell/kg-10.0×10\^6 CAR T cell/kg
(一) Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
The overall response rate (ORR)
Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
Overall Survival (OS)
Determination of the overall survival times of all patients.
PK(Pharmacokinetics):Tmax
Time to peak plasma concentration (Tmax)
PK(Pharmacokinetics):Cmax
Maximum serum concentration(Cmax)
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