Diffuse Large B-Cell Lymphoma (DLBCL) Clinical Trials

• Age ≥ 18 years and ≤ 80 years, either gender, life expectancy \> 6 months.

• Histopathologically confirmed diffuse large B-cell lymphoma (DLBCL), CD20-positive, and immunohistochemically CD5-positive .

• Note: Patients must provide a local pathological report before screening or sufficient fresh or paraffin-embedded tissue to confirm the CD5+ IHC result.

• No prior therapy for DLBCL, including chemotherapy, targeted therapy, immunotherapy, local radiotherapy for lymphoma (except palliative local radiotherapy for tumor-related symptoms), or surgical treatment (except tumor/pathologic biopsy and non-lymphoma-directed surgical resection).

• At least one assessable or measurable lesion according to the Lugano 2014 criteria:

‣ Lymph node lesion: longest diameter \> 1.5 cm;

⁃ Extranodal lesion: longest diameter \> 1.0 cm.

• International Prognostic Index (IPI) score 0-5, stage III-IV disease.

• ECOG performance status 0-2.

• Laboratory results must meet the following criteria prior to the first dose:

• \- Bone marrow function: WBC ≥ 3×10⁹/L, HGB ≥ 90 g/L, ANC ≥ 1.5×10⁹/L, PLT ≥ 80×10⁹/L;

⁃ Liver function: TBIL ≤ 1.5×ULN; ALT or AST ≤ 2.5×ULN (≤ 5×ULN if liver involvement); ALP ≤ 3×ULN in patients without bone involvement;

⁃ Renal function: serum creatinine ≤ 1.5×ULN, or estimated glomerular filtration rate ≥ 50 mL/min by the Cockcroft-Gault equation;

⁃ PT, APTT, INR ≤ 1.5×ULN unless receiving anticoagulation.

• Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography at screening.

• Female patients of childbearing potential must have a negative serum or urine pregnancy test within 7 days before enrollment, agree to use effective contraception during study participation and for ≥ 12 months after the last dose.

∙ Male patients must agree to use effective contraception during study participation and for ≥ 3 months after the last dose.

∙ 10\. Understand and voluntarily provide written informed consent.

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