New hope for rare blood cancer: drug combo targets relapsed lymphoma
NCT ID NCT05700448
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding the drug sugemalimab to standard chemotherapy can help adults with a rare type of blood cancer (NK/T-cell lymphoma) that has returned or stopped responding to previous treatment. About 150 participants will receive either the new combination or a placebo plus chemo. The goal is to see if the combination delays cancer growth and improves survival.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2027
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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 to 75 years
- 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: * Has ENKTL histologically confirmed by the study center. Nasal and non-nasal ENKTL are both allowed. * Has relapsed or refractory ENKTL after prior asparaginase-based chemotherapy or chemoradiotherapy. * Has Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. * Has at least one measurable lesion per Lugano 2014 classification. * Is willing to provide stained tumor tissue sections and corresponding pathological reports or unstained tumor tissue sections (or tissue block) for central pathology review. * Has adequate organ function. * Has life expectancy of greater than 3 months. Exclusion Criteria: * Has aggressive natural killer-cell leukemia, current central nervous system (CNS) involvement or is concomitant with hemophagocytic lymphohistiocytosis. * Has known additional malignancy within 5 years prior to randomization. * Has an active autoimmune disease or has had an autoimmune disease that may relapse. * Has had a major surgical procedure within 28 days or radiotherapy within 90 days before the first dose of study treatment. * Has active tuberculosis infection. * Has a known history of human immunodeficiency virus (HIV) infection and/or acquired immune deficiency syndrome (AIDS). * Has a known active Hepatitis B or C virus infection. * Has received systemic anti-cancer therapy within 28 days before the first dose of study treatment, including chemotherapy, immunotherapy, biological therapy (e.g. cancer vaccine, cytokine therapy or growth factors to treat cancer). * Has used traditional Chinese medicines or herbal preparations with anti-tumor indications within 7 days before the first dose of study treatment. * Has received systemic corticosteroid or any other immunosuppressive therapy within 14 days before the first dose of study treatment. * Has received any treatment of antibody or drug that targets at T-cell coregulatory pathways or immune checkpoint pathways. * Has toxicity from prior anti-cancer treatment, except for alopecia and fatigue, that has not recovered to baseline or ≤ Grade 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 before the first dose of study treatment. * Has had allogenic hematopoietic stem cell transplantation (HSCT) within 5 years or autologous HSCT within 90 days before the first dose of study treatment. * Has a known severe hypersensitivity to sugemalimab, its active substance and/or any of its excipients, or to other monoclonal antibodies. * Female participants who are pregnant or breastfeeding. * Is currently participating in or has participated in a trial of an investigational agent within 28 days before to the first dose of study treatment.
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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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Other studies related to the condition(s) this trial covers.
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