A Phase II Study of Stapokibart Combined With Immune Checkpoint Inhibitors in Relapsed/Refractory Lymphoma

A Phase II Open-label Clinical Study of Stapokibart Combined With Immune Checkpoint Inhibitors in Patients With Relapsed/Refractory Lymphoma

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.

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. This study takes NK/T-cell lymphoma as the primary study subtype, with Hodgkin lymphoma, primary mediastinal large B-cell lymphoma and other subtypes as exploratory subtypes.

Inclusion Criteria:

Aged ≥ 18 years, with no restriction on gender. Voluntarily sign the informed consent form (ICF) and comply with study requirements.

Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1. Patients with relapsed or refractory lymphoma who have failed prior treatment with single-agent or combination immune checkpoint inhibitor regimens (the interval between treatment failure and study treatment shall not exceed one line of therapy), or have not achieved remission after 4 cycles of single-agent immune checkpoint inhibitor therapy.

Have at least one measurable target lesion assessed per the Lugano 2014 criteria (long diameter > 15 mm for lymph node lesions, or long diameter > 10 mm for extranodal lesions).

Laboratory examinations conducted within 7 days prior to the first study drug administration confirm adequate bone marrow, hepatic, renal and coagulation function:

1. 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.
2. 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.
3. Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min (calculated by the Cockcroft-Gault formula).
4. International Normalized Ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.

Exclusion Criteria:

Received any anti-tumor therapy, including cytotoxic chemotherapy, targeted therapy, monoclonal antibodies, antibody-drug conjugates, or investigational drugs, within 28 days or 5 half-lives (whichever is shorter) prior to the first study drug administration.

Received anti-tumor traditional Chinese patent medicines (with clearly indicated anti-tumor indications in the prescribing information) within 14 days before the first study drug administration.

Received systemic glucocorticoid therapy within 14 days before the first study drug administration (inhaled or topical glucocorticoids are permitted; prednisone ≤ 10 mg daily or equivalent dose for no more than 7 consecutive days is allowed) or received immunosuppressive agents (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-tumor necrosis factor agents, etc.).

Received radiotherapy within 14 days, or palliative radiotherapy for non-central nervous system lesions within 7 days prior to the first study drug administration.

Underwent major surgery within 28 days before the first study drug administration, or planned to receive major surgery during the study period.

Received live or attenuated live vaccines within 28 days before the first study drug administration, or planned to receive such vaccines during the study.

Experienced Grade ≥ 3 immune-related adverse events (irAEs) during prior immune checkpoint inhibitor treatment (except Grade 3 endocrine irAEs manageable with alternative treatment and resolved Grade 3 cytokine release syndrome), or Grade 1-2 irAEs that failed to return to baseline after treatment discontinuation.

Have a known severe hypersensitivity to monoclonal antibodies. History of human immunodeficiency virus (HIV) infection or positive HIV antibody.

Presence of active Mycobacterium tuberculosis infection or syphilis infection. Fungal, bacterial, viral or other infections requiring intravenous infusion treatment within 28 days prior to the first study drug administration.

Central nervous system involvement. Uncontrolled pleural effusion, ascites or pericardial effusion as assessed by the investigator.

History of other malignant tumors within 5 years prior to the first study drug administration, excluding cured basal cell carcinoma or squamous cell carcinoma of the skin, cervical carcinoma in situ, or ductal carcinoma in situ of the breast.

Any other medical history, treatment, laboratory abnormality, or other conditions that may confound study results, interfere with subject compliance, or jeopardize the subject's interests, as judged by the investigator.