This is a phase 1, single-center, dose selection study to evaluate the efficacy, safety, and pharmacokinetics of ThisCART19A (allogeneic CAR-T targeting CD19) in patients with Auto-CAR T relapsed B-cell non-Hodgkin's lymphoma.
This is a phase 1, single-center, dose selection study to evaluate the efficacy, safety, and pharmacokinetics of ThisCART19A in patients with Auto-CAR T relapsed B-cell non-Hodgkin's lymphoma. The study will identify a treatment regimen most likely to result in clinical efficacy while maintaining a favorable safety profile. Before initiating ThisCART19A infusion, subjects will be administered lymphodepletion chemotherapy composed of fludarabine、cyclophosphamide and VP-16. At Day 0 of the Treatment Period, subjects will receive an intravenous (IV) infusion of ThisCART19A. All subjects are monitored during the treatment period through Day 28. All subjects who receive a dose of ThisCART19A will be followed up to 2 years.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
ThisCART19A,2×10\^6 cells/kg(Single dose of Allogeneic Anti-CD19 CAR T cells will be infused), after the lymphodepletion conditioning of fludarabine, CTX and VP-16
ThisCART19A,3×10\^6 cells/kg(Single dose of Allogeneic Anti-CD19 CAR T cells will be infused), after the lymphodepletion conditioning of fludarabine, CTX and VP-16
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGBOR
Best Overall Response Rate
Time frame: 3 month
ORR
Objective response rate
Time frame: 2 year
CR
Complete response rate
Time frame: 2 year
TTR
Time to response
Time frame: 3 month
DOR
Duration of response
Time frame: 2 year
EFS
Event-free survival
Time frame: 2 year
PFS
Progression-free survival
Time frame: 2 year
OS
Overall survival
Time frame: 2 year
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