About this trial
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 .
Eligibility criteria
Qualifiers
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).
Disqualifiers
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 ;
Trial design
Treatments tested in this trial
- ssCART-19