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
6
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
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
AE
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 12 weeks
Overall response rate (ORR)
The ORR will be assessed at weeks 4 ,weeks 12 ,months 6 and months 12
Time frame: 12 months
Duration of remission (DOR)
The DOR will be assessed at months 12
Time frame: 12 months
Progression free survival (PFS)
The PFS will be assessed at months 12
Time frame: 12 months
Overall survival rate(OSR)
The OSR will be assessed at weeks 12 ,months 6 and months 12
Time frame: 12 months
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