LymphomaPhase 2NCT07791615
A Phase II Study of Stapokibart Combined With Immune Checkpoint Inhibitors in Relapsed/Refractory Lymphoma
A Phase 2 study testing Stapokibart, immune checkpoint inhibitor in people with Lymphoma and NK T-Cell Lymphoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, NK T-Cell Lymphoma
- What is being tested?
- Stapokibart, immune checkpoint inhibitor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Jun 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Lymphoma, NK T-Cell Lymphoma
- Being tested
- Stapokibart, immune checkpoint inhibitor
- Medical subject headings
- Lymphoma, Lymphoma, Extranodal NK-T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stapokibart, immune checkpoint inhibitorDrug
Stapokibart, subcutaneous injection (SC), every 3 weeks (Q3W); Immune checkpoint inhibitor (Nivolumab, Pembrolizumab, Sintilimab), Q3W; until disease progression.
| Study group | Role | What they receive |
|---|---|---|
| Stapokibart combination investigational arm | Experimental | Participants will receive combination therapy with stapokibart and an immune checkpoint inhibitor. Receives: Drug: Stapokibart, immune checkpoint inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
Overall response rate
Measured: 6 months
Treatment-Emergent Adverse Event (TEAE), Treatment-Related Adverse Event (TRAE)
safety
Measured: through study completion, an average of 1.5 years
Secondary outcomes (1)
Progression-Free Survival (PFS)
response, disease control period
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study startDec 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peng Liu, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791615
- Sponsor's protocol ID
- Stapo-IIS-Lym01
- Status last verified
- Apr 2026
- First submitted
- 14 Jun 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Open-label Clinical Study of Stapokibart Combined With Immune Checkpoint Inhibitors in Patients With Relapsed/Refractory Lymphoma
- ClinicalTrials.gov ID
- NCT07791615
- Acronym / sponsor ID
- Stapo-IIS-Lym01
- Conditions
- Lymphoma, NK T-Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stapokibart combination investigational arm | Experimental | Drug: Stapokibart, immune checkpoint inhibitorParticipants will receive combination therapy with stapokibart and an immune checkpoint inhibitor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stapokibart, immune checkpoint inhibitorStapokibart, subcutaneous injection (SC), every 3 weeks (Q3W); Immune checkpoint inhibitor (Nivolumab, Pembrolizumab, Sintilimab), Q3W; until disease progression. | Drug | Stapokibart combination investigational arm |
Primary outcome
Overall response rate (ORR)
Time frame: 6 months
Overall response rate
Treatment-Emergent Adverse Event (TEAE), Treatment-Related Adverse Event (TRAE)
Time frame: through study completion, an average of 1.5 years
safety
1 secondary outcome
Progression-Free Survival (PFS)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
Related trials for Lymphoma
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Not yet recruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peng Liu principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stapokibart, immune checkpoint inhibitor in people with Lymphoma and NK T-Cell Lymphoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peng Liu (86 010 87788293, zlyywyr@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.