Can a new drug combo revive immunotherapy for lymphoma?
NCT ID NCT07791615
First seen Aug 28, 2026 · Last updated Aug 28, 2026
Summary
This phase II trial tests whether adding stapokibart to standard immune checkpoint inhibitors can help people with relapsed or refractory lymphoma, a type of blood cancer that has not responded to or has returned after prior treatment. About 20 adults who have already failed immune checkpoint inhibitor therapy will receive stapokibart by injection every three weeks along with an immune checkpoint inhibitor. Researchers will measure how many patients see their tumors shrink and track side effects to see if the combination is safe and worth further study.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Stapokibart combined with an immune checkpoint inhibitor (nivolumab, pembrolizumab, or sintilimab)
- What this could lead to
- If it works, this combination could offer a new treatment option for people with lymphoma that has not responded to or has returned after immune checkpoint inhibitor therapy.
- What could go wrong
- This is a small, early-phase trial with only 20 participants, so results may not apply broadly. The combination may cause side effects or fail to improve response rates.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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