Trials / Not Yet Recruiting
Not Yet RecruitingNCT05700448
Study of Sugemalimab (or Placebo) Plus PGemOx Regimen in Participants With Extranodal NK/T-Cell Lymphoma
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)
- Status
- Not Yet Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- CStone Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Sugemalimab | IV infusion |
| DRUG | Placebo | IV infusion |
| DRUG | Pegaspargase | Intramuscular injection |
| DRUG | Gemcitabine | IV infusion |
| DRUG | Oxaliplatin | IV infusion |
Timeline
- Start date
- 2026-06-01
- Primary completion
- 2028-12-01
- Completion
- 2029-12-01
- First posted
- 2023-01-26
- Last updated
- 2026-02-05
Source: ClinicalTrials.gov record NCT05700448. Inclusion in this directory is not an endorsement.