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Study of Sugemalimab (or Placebo) Plus PGemOx Regimen in Participants With Extranodal NK/T-Cell Lymphoma

NCT05700448 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-02-05

No results posted yet for this study

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

  • Extranodal NK/T-cell Lymphoma

Interventions

DRUG

Gemcitabine

IV infusion

DRUG

Oxaliplatin

IV infusion

BIOLOGICAL

Sugemalimab

IV infusion

DRUG

Placebo

IV infusion

DRUG

Pegaspargase

Intramuscular injection

Sponsors & Collaborators

Principal Investigators

  • Qinzhou Qi · CStone Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-12-31
Completion
2029-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05700448 on ClinicalTrials.gov