A Phase 2 interventional study of Stapokibart, immune checkpoint inhibitor in Lymphoma and NK T-Cell Lymphoma, sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Phase 2, Interventional, and Treatment
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.
3,018 studies on the registry are indexed under Lymphoma; 434 are open to participants now.
This study's planned enrollment of 20 is below the median of 43 across 2,319 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Cancer Institute and Hospital, Chinese Academy of Medical Sciences is the lead sponsor of 393 studies on the registry; 280 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Aged ≥ 18 years, with no restriction on gender. Voluntarily sign the form (ICF) and comply with study requirements.
(ECOG) performance status score of 0 to 1. Patients with lymphoma who have failed prior treatment with single-agent or combination regimens (the interval between treatment failure and study treatment shall not exceed one ), 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:
Exclusion Criteria:
Received any anti-tumor therapy, including cytotoxic chemotherapy, targeted therapy, monoclonal antibodies, antibody-drug conjugates, or 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 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 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 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 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 to monoclonal antibodies. History of (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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive combination therapy with stapokibart and an immune checkpoint inhibitor.
Drug: Stapokibart, immune checkpoint inhibitor
Drug pages: Stapokibart · Immune checkpoint inhibitors
Stapokibart, subcutaneous injection (SC), every 3 weeks (Q3W); Immune checkpoint inhibitor (Nivolumab, Pembrolizumab, Sintilimab), Q3W; until disease progression.
This study also gives Pembrolizumab, Nivolumab. No intervention listed here names it: that was found by reading the record.
Overall response rate (ORR)
Overall response rate
Time frame: 6 months
Treatment-Emergent Adverse Event (TEAE), Treatment-Related Adverse Event (TRAE)
safety
Time frame: through study completion, an average of 1.5 years
Progression-Free Survival (PFS)
response, disease control period
Time frame: 12 months
No study locations are listed for this record.
Start is estimated for Dec 2026; primary completion for Jun 2028, 18 months later.
Of 237 non-industry phase 2 interventional studies under Lymphoma, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 42 and three quarters within 114. This study's planned 18 months is below that.
Counting every sponsor, half of 293 studies reached it within 61 months; a quarter within 36 and three quarters within 105.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Stapokibart · Immune checkpoint inhibitors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences →