CStone Pharmaceuticals
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.
Extranodal NK/T-cell Lymphoma
Sugemalimab
Placebo
Pegaspargase
Gemcitabine
Oxaliplatin
Phase 3
Study Type : | Interventional |
Estimated Enrollment : | 150 participants |
Masking : | Quadruple |
Primary Purpose : | Treatment |
Official Title : | A Phase III, Randomized, Double-Blind, Multicenter Study of Sugemalimab (CS1001) Plus PGemOx Regimen Versus Placebo Plus PGemOx for Subjects With Relapsed or Refractory Extranodal NK/T-Cell Lymphoma (R/R ENKTL) |
Actual Study Start Date : | July 2024 |
Estimated Primary Completion Date : | November 2027 |
Estimated Study Completion Date : | November 2028 |
Arm | Intervention/treatment |
---|---|
Experimental: Sugemalimab+PGemOx Participants receive sugemalimab 1200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS PGemOx regimen Q3W (pegaspargase 2000-2500 IU/m^2 via intramuscular injection on Day 1, gemcitabine 1000 mg/m^2 via IV infusion on Days 1 & 8 and oxaliplatin 130 mg/m^2 via IV infusion on Day 1. |
Biological: Sugemalimab Drug: Pegaspargase Drug: Gemcitabine Drug: Oxaliplatin |
Placebo Comparator: Placebo+PGemOx Participants receive placebo via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS PGemOx regimen Q3W (pegaspargase 2000-2500 IU/m^2 via intramuscular injection on Day 1, gemcitabine 1000 mg/m^2 via IV infusion on Days 1 & 8 and oxaliplatin 130 mg/m^2 via IV infusion on Day 1. |
Drug: Placebo Drug: Pegaspargase Drug: Gemcitabine Drug: Oxaliplatin |
Ages Eligible for Study: | 18 Years to 75 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.