This study is a multicenter, non randomized, single arm, open clinical trial. The selected disease was relapsed / refractory NHL, and the disease was classified into highly aggressive lymphoma, invasive lymphoma and inert lymphoma; Highly invasive NHL included Burkitt lymphoma (BL), lymphoblastic lymphoma (LBL), high-grade B-cell lymphoma, etc; Invasive NHL includes diffuse large B-cell lymphoma, mantle cell lymphoma and peripheral T-cell lymphoma; Inert NHL contains follicular lymphoma, small lymphocytic lymphoma and marginal zone lymphoma.
A single car consists of scFv, hinge region, transmembrane region, costimulatory domain and zeta subunit of CD3.Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Biological: Auto CAR-T
Drug: Cyclophosphamide,Fludarabine
Leukapheresis
Hematology Department, Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, China
RECRUITINGSafety: Incidence and severity of adverse events
To evaluate the possible adverse events occurred within first one month after CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
Time frame: first one month after CAR-T infusion
Efficacy: Remission Rate
Remission Rate including complete remission (CR), partial remission (PR), objective response (ORR = CR + PR), disease stability (SD), disease progression (PD) and unresponsive (NR)
Time frame: 3 months post CAR-T cells infusion
Efficacy:duration of response (DOR)
duration of response (DOR)
Time frame: 24 months after CAR-T infusion
Efficacy: progression-free survival (PFS)
progression-free survival (PFS) time
Time frame: 24 months after CAR-T infusion
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