Efficacy and Safety Evaluation of U01(ssCART-19) in B-Cell Lymphoma

Inclusion Criteria

• •1. Participants must voluntarily sign the informed consent form (ICF) and demonstrate good compliance.
• •2. Participants must meet the following requirements:
• •1. 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.
• •2. Confirmed diagnosis of B-cell lymphoma according to the NCCN Clinical Practice Guidelines for B-Cell Lymphomas (3rd Edition, 2024) .
• •3. Prior treatment requirements :
• •Failure to achieve partial response (PR) after first-line therapy, or relapse within 12 months post-first-line therapy; Relapsed/refractory B-cell lymphoma after second-line therapy (one standard chemotherapy regimen + one salvage regimen).
• •Prior treatments must include CD20 monoclonal antibody (unless CD20-negative tumor confirmed by the investigator) and anthracycline-based regimens .
• •Additionally, meet one of the following:
• •i. Ineligible for autologous stem cell transplantation (ASCT); ii. Refusal of ASCT; iii. Post-ASCT relapse. d) Refractory/relapsed status at screening: Relapse: Disease progression (PD) after achieving PR or complete response (CR);
• •Refractory:
• •i. No response to last-line therapy (PD during/after treatment, or stable disease \[SD\] lasting \<6 months); ii. Post-ASCT relapse/PD (biopsy-confirmed), including relapse/PD within 12 months post-ASCT with SD/PD after salvage therapy2.
• •3. CD19 positivity confirmed by immunohistochemistry (IHC) of tumor tissue (preferably within 6 months).
• •4. At least one measurable lesion assessed by the Lugano Lymphoma Response Criteria (Cheson 2014) .
• •5. ECOG performance status score 0-3 .
• •6. Adequate bone marrow reserve at screening:
• •Absolute lymphocyte count (ALC) ≥0.3×10⁹/L ; Platelet count (PLT) ≥30×10⁹/L .
• •7. Adequate organ function:
• •AST/ALT ≤3×ULN (≤5×ULN if due to tumor infiltration); Total bilirubin ≤2×ULN (≤3×ULN for Gilbert syndrome with direct bilirubin ≤1.5×ULN); Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min (Cockcroft-Gault formula); Oxygen saturation \>91% on room air (dyspnea grade ≤1); Left ventricular ejection fraction (LVEF) ≥50% ; INR ≤1.5×ULN and APTT ≤1.5×ULN .
• •8. Negative pregnancy test (blood/urine) within 7 days before CAR-T infusion for women of childbearing potential. All participants must agree to use effective contraception during the study and for ≥1 year post-treatment.
• •9. Adequate venous access for leukapheresis or blood collection, with no contraindications to leukapheresis.
• •10. Expected survival ≥3 months .