This is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of infusion of autologous CD19-targeted chimeric antigen receptor (CD19 CAR) T cells in adult patients with relapsed and refractory B-cell Non-Hodgkin lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JWCAR029. During JWCAR029 production, subjects will receive a conditioning chemotherapy regimen of cyclophosphamide and fludarabine for the purpose of lymphocytes depletion. After lymphodepletion, subjects will receive one dose treatment with JWCAR029 by intravenous (IV) injection.
Ruijin hospital
Shanghai, Shanghai Municipality, China
Treatment-related adverse events (AEs)
Physiological parameter
Time frame: 2 years
Dose-limiting toxicities of JWCAR029
Physiological parameter
Time frame: 28 days after JWCAR029 infusion
Objective response rate (ORR)
Lugano criteria
Time frame: 2 years
Maximum concentration (Cmax) of JWCAR029 in the peripheral blood and bone marrow
Flow cytometry and qPCR
Time frame: 1 year after JWCAR029 infusion
Time to maximum concentration (Tmax) of JWCAR029 in the peripheral blood and bone marrow
Flow cytometry and qPCR
Time frame: 1 year after JWCAR029 infusion
Area-under the concentration-vs-time-curve (AUC) of JWCAR029 in the peripheral blood and bone marrow
Flow cytometry and qPCR
Time frame: 1 year after JWCAR029 infusion
Complete response (CR) rate
Lugano criteria
Time frame: 2 years
Duration of response
Lugano criteria
Time frame: 2 years
Progression-free survival (PFS) and PFS ratio
Lugano criteria
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Time frame: 2 years
Overall survival
Physiological parameter
Time frame: 2 years
Health-related quality of life (HRQoL)
Questionnaire
Time frame: 2 years