This study seeks to examine the efficacy and safety of the administration of autologous T cells that have been modified through the introduction of a chimeric antigen receptor (CAR) targeting the B cell surface antigen CD19 following administration of chemotherapy lymphodepletion regimen in children with relapsed or refractory acute lymphoblastic leukemia (ALL) or lymphoma. The overall goal of this study is to validate the safety profile of administration CD19-CAR T cells and describe the response rate in children with relapsed/refractory ALL or lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
CAR-T cell (CHXCART01) infusion intravenously once at a dose of 0.2-2 million cells/kg recipient body weight
Hong Kong Children's Hospital
Hong Kong, Hong Kong
RECRUITINGComplete response rate (CRR) for ALL and Overall response rate (ORR) for lymphoma
Complete response for ALL was defined as leukemic cells \<5% in bone marrow. Overall response for lymphoma was defined as complete response plus partial response defined by Lugano criteria.
Time frame: 1 month for subjects with ALL, and 3 months for subjects with lymphoma
Incidence and severity of adverse events
Severity of adverse events are graded according to CTCAEv5.0.
Time frame: through study completion, an average of 6 months
Frequency of minimal residual disease for ALL
Measurable residual disease in bone marrow by flow cytometry or PCR methods.
Time frame: 1 month
Overall survival
survival as estimated by Kaplan-Meier method. Death from any cause is considered as event for analysis.
Time frame: 1 year
Event-free survival
Event-free survival as estimated by Kaplan-Meier method. Events are death from any cause, or relapse or progression of underlying disease.
Time frame: 1 year
Proportion of products successfully manufactured
Success defined as meeting product release criteria with at least 0.2 million cells/kg recipient body weight
Time frame: at the time of CAR-T cell infusion
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