This is a single arm, single-center, non-randomized study to evaluate the safety and efficacy of C-CAR011 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
10
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 Lymphoma, Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
Safety: Vital signs, physical examination, clinical laboratory tests, incidence of adverse events (AEs) and serious adverse events (SAEs)
Vital signs, physical examination, clinical laboratory tests, incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 12 weeks
Overall response rate (ORR)
Time frame: 12 weeks
Overall response rate (ORR)
Time frame: 6 months
Overall 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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