Chimeric antigen receptor T cells (CAR-T cells) have been developed to treat relapsed and refractory hematological malignancies with promising outcome in patients with very poor prognosis. The purpose of this clinical study is to produce the CD19\[cluster of differentiation antigen 19\] CAR-T (SNUH-CD19-CAR-T) at the investigational site and to evaluate safety and efficacy of SNUH-CD19-CAR-T in children and adolescent with relapsed/refractory B-cell acute lymphoblastic leukemia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
SNUH-CD19-CAR-T is an autologous CAR-T from T cells collected from each patient. Administer a single dose of SNUH-CD19-CAR-T to patients with relapsed or refractory CD19 positive B-cell acute lymphoblastic leukemia, and evaluate safety and efficacy of SNUH-CD19-CAR-T for 12 months after the infusion.
Seoul National University Hospital
Seoul, South Korea
RECRUITINGIncidence of adverse events and its severity
Time frame: 12 months post SNUH-CD19-CAR-T infusion
Patients with CR[complete remission] after Hospital-manufactured CAR-T infusion
Time frame: 1 month post SNUH-CD19-CAR-T infusion
Overall survival and event-free survival
Time frame: 12 months post SNUH-CD19-CAR-T infusion
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