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 2026-06
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 range18 Years – 75 Years
SexALL
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…
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