This is an open-label phase1 study to assess the safety and efficacy of U01(ssCART-19) cell therapy in the treatment of patients with refractory or recurrent B-cell lymphoma .
Participants must voluntarily sign the informed consent form (ICF) and demonstrate good compliance.
Age ≥2 years and ≤75 years at the time of signing the ICF (both sexes eligible). For minors (<18 years), the legal guardian must sign after full disclosure; minors with decision-making capacity must co-sign with their guardians.
Confirmed diagnosis of B-cell lymphoma according to the NCCN Clinical Practice Guidelines for B-Cell Lymphomas (3rd Edition, 2024) .
CD19 positivity confirmed by immunohistochemistry (IHC) of tumor tissue (preferably within 6 months).
Uncontrolled infections (bacterial, fungal, viral, mycoplasmal, or others) as determined by the investigator;
Primary immunodeficiency ;
Severe immediate hypersensitivity to any study drug;
Live vaccine administration within 6 weeks prior to screening ;
Single group
ssCART-19
Biological/Vaccineautologous T cells transduced with a lentiviral vector containing anti-CD19 CAR and small hairpin RNA to silence the IL-6 gene
The types, frequency, and severity of treatment related adverse events
After CAR-T cell infusion, we will observe the potential adverse events, especially Cytokine Release Syndrome(CRS) and neurotoxicity Using NCI Common Terminology Criteria for Adverse Events(CTCAE) V5.0
Objective response rate(ORR)
Duration of response (DOR)
Progression free survival(PFS)
Kinetics of CAR-T cells
Use flow cytometry or qPCR to monitor the kinetics of CAR-T cells
Monitoring changes in IL-6, ferritin, and CRP in peripheral blood following CAR-T cell infusion
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