This is a single arm, single-center, non-randomized study to evaluate the safety and efficacy of C-CAR011 therapy in relapsed or refractory B cell Non-Hodgkin Lymphoma (NHL).
This is a single arm, single-center, non-randomized study to evaluate the safety and efficacy of C-CAR011 therapy in relapsed or refractory B cell Non-Hodgkin Lymphoma (NHL). The study will include the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation; Lymphodepleting Chemotherapy), Treatment and Follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Autologous 2nd generation CD19-directed CAR-T cells, single infusion intravenously at a target dose of 0.5-5.0 x 10\^6 anti-CD19 CAR+ T cells/kg
Department of Hematology,Shanghai Tongji Hospital, Tongji University School of Medicin
Shanghai, China
RECRUITINGSafety(Incidence of adverse events)
Incidence of adverse events (AEs)
Time frame: 12 weeks
Objective response rate (ORR)
Time frame: 12 weeks
Objective response rate (ORR)
Time frame: 12 months
Duration of remission(DOR)
Time frame: 12 months
Progression free survival(PFS)
Time frame: 12 months
Overall survival(OS)
Time frame: 12 months
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