The purpose of the study is to evaluate the safety and tolerability of B019 in subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
B019: Intravenous infusion, 1.0×10\^6 CAR T cell/kg-10.0×10\^6 CAR T cell/kg
Peking University People's Hospital
Beijing, China
RECRUITINGJiangxi Province pediatric hospital
Nanchang, China
RECRUITINGThe First Affiliated Hospital of Nanchang University
Nanchang, China
(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)
Time frame: Approximately 2 years
The overall response rate (ORR)
Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
Time frame: 3 months
Overall Survival (OS)
Determination of the overall survival times of all patients.
Time frame: Approximately 2 years
PK(Pharmacokinetics):Tmax
Time to peak plasma concentration (Tmax)
Time frame: Approximately 2 years
PK(Pharmacokinetics):Cmax
Maximum serum concentration(Cmax)
Time frame: Approximately 2 years
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Children's Hospital of Shanghai
Shanghai, China
RECRUITINGShanghai Children's Medical Center
Shanghai, China
RECRUITINGChildren's Hospital of Soochow University
Suzhou, China
RECRUITINGTongji Hospital
Wuhan, China
RECRUITINGThe Affiliated Hospital of Xuzhou Medical University
Xuzhou, China
RECRUITING