To evaluate the safety and efficacy of SL19+22 in patients with relapsed or refractory non-Hodgkin's lymphoma.
SL19+22 injection is a CAR-T product independently developed by Senlang that targets both CD19 and CD22. Based on the traditional CAR T treatment regimen, the CAR structure was designed, and the activation mode of T cells was changed by using cytokine combination amplification and improved transfection technology. The Main research objectives: To evaluate the safety and efficacy of SL19+22 in patients with recurrent or refractory non-Hodgkin's lymphoma The Secondary research objectives: To investigate the cytokinetic characteristics of SL19+22 in patients with recurrent or refractory non-Hodgkin's lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Biological: CD19+22 CAR-T; Drug: Cyclophosphamide,Fludarabine;
Hebei Yanda Ludaopei Hospital
Langfang, Hebei, China
RECRUITINGSafety: Incidence and severity of adverse events
To evaluate the possible adverse events could occurred within first month post infusion.
Time frame: First month post CAR-T cells infusion
Efficacy: Overall Remission Rate (ORR)
Overall Remission Rate (ORR) including partial remission and complete remission rate after infusion of SL19+22
Time frame: 3 months post CAR-T cells infusion
Efficacy:duration of response (DOR)
duration of response (DOR)
Time frame: 24 months post CAR-T cells infusion
Efficacy: progression-free survival (PFS)
progression-free survival (PFS) time
Time frame: 24 months post CAR-T cells infusion
CAR-T proliferation
the copy number of CD19 and CD22 CAR- T cells in the genomes of PBMC by qPCR
Time frame: 3 months post CAR-T cells infusion
Cytokine release
Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry
Time frame: First month post CAR-T cells infusion
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