This is an open-label clinical study designed to evaluate the efficacy of Stapokibart combined with immune checkpoint inhibitors in patients with relapsed/refractory lymphoma. Approximately 20 patients with relapsed/refractory lymphoma who have failed prior immune checkpoint inhibitor therapy or failed to achieve remission are planned to be enrolled.
No blood transfusion or hematopoietic stimulating factors (including Granulocyte Colony-Stimulating Factor, Granulocyte-Macrophage Colony-Stimulating Factor, Thrombopoietin, Erythropoietin) are permitted within 2 weeks before testing; absolute neutrophil count ≥ 1.5×10⁹/L, platelet count ≥ 75×10⁹/L, and hemoglobin ≥ 90 g/L.
Alanine transaminase (ALT) / aspartate transaminase (AST) ≤ 3.0 × upper limit of normal (ULN); total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for patients with Gilbert's syndrome); albumin ≥ 28 g/L.
Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min (calculated by the Cockcroft-Gault formula).
International Normalized Ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
None
Single group
Stapokibart, immune checkpoint inhibitor
DrugStapokibart, subcutaneous injection (SC), every 3 weeks (Q3W); Immune checkpoint inhibitor (Nivolumab, Pembrolizumab, Sintilimab), Q3W; until disease progression.
Overall response rate (ORR)
Overall response rate
Treatment-Emergent Adverse Event (TEAE), Treatment-Related Adverse Event (TRAE)
safety
Progression-Free Survival (PFS)
response, disease control period
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