Study of Sugemalimab (or Placebo) Plus PGemOx Regimen in Participants With Extranodal NK/T-Cell L… (NCT05700448) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Study of Sugemalimab (or Placebo) Plus PGemOx Regimen in Participants With Extranodal NK/T-Cell Lymphoma
150 participantsStarted 2027-06
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of sugemalimab (CS1001) in combination with PGemOx regimen (pegaspargase, gemcitabine, oxaliplatin) in treatment of adult patients with Extranodal NK/T-Cell Lymphoma (ENKTL) who have relapsed or become refractory to asparaginase-based regimens.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-free survival (PFS) evaluated by blinded independent central review (BICR) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Timeframe: Approximately 39 months after First Patient In