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Phase 3Not yet recruitingPriority 1 · Highest priorityNCT05700448

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

ClinicalTrials.gov

Plain-language summary

This Phase 3 trial is comparing Sugemalimab, Placebo, and other medications against other options for people whose NK/T-cell lymphoma has come back or has not responded to previous treatment. Patients are randomly assigned to different treatment groups to see which approach works best. This trial does not currently list US sites.

Who can join (key eligibility)

  • Age 18 Years to 75 Years years
  • Lymphoma came back or did not respond to prior treatment
  • Must be well enough for treatment (adequate performance status)

Final eligibility is determined by the trial team. This list is a starting point only.

What's being tested

Sugemalimab (BIOLOGICAL): IV infusion | Placebo (DRUG): IV infusion | Pegaspargase (DRUG): Intramuscular injection | Gemcitabine (DRUG): IV infusion | Oxaliplatin (DRUG): IV infusion

Drugs / treatments
Sugemalimab, Placebo, Pegaspargase, Gemcitabine, Oxaliplatin
Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details

At a glance

Phase
Phase 3
Status
Not yet recruiting
Design
Randomized, quadruple blind
Enrollment target
150 patients
Primary endpoint
Progression-free survival (PFS) evaluated by blinded independent central review (BICR) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Ages
18 Years to 75 Years
Start date
2027-06
Est. completion
2030-12

Locations

0 US sites · 0 total

No US sites currently listed.

Contact

Sponsor
CStone Pharmaceuticals (INDUSTRY)
Contact
Wenyun Zhang | cstoneRA@cstonepharma.com | +86 021-60333416

Tags

ENKTLRelapsed/Refractory
TrialCompass — Clinical Trial Summary

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

NCT05700448

Phase: Phase 3 | Status: Not yet recruiting | Priority: Highest

Plain-language summary

This Phase 3 trial is comparing Sugemalimab, Placebo, and other medications against other options for people whose NK/T-cell lymphoma has come back or has not responded to previous treatment. Patients are randomly assigned to different treatment groups to see which approach works best. This trial does not currently list US sites.

Who can join

  • Age 18 Years to 75 Years years
  • Lymphoma came back or did not respond to prior treatment
  • Must be well enough for treatment (adequate performance status)

What's being tested

Sugemalimab (BIOLOGICAL): IV infusion | Placebo (DRUG): IV infusion | Pegaspargase (DRUG): Intramuscular injection | Gemcitabine (DRUG): IV infusion | Oxaliplatin (DRUG): IV infusion

Drugs / treatments: Sugemalimab, Placebo, Pegaspargase, Gemcitabine, Oxaliplatin

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Randomized, quadruple blind

Enrollment target: 150 patients

Primary endpoint: Progression-free survival (PFS) evaluated by blinded independent central review (BICR) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification

Ages: 18 Years to 75 Years

Start date: 2027-06 | Est. completion: 2030-12

Locations

0 US sites · 0 total

Contact

Wenyun Zhang | cstoneRA@cstonepharma.com | +86 021-60333416

Sponsor: CStone Pharmaceuticals (INDUSTRY)

Tags

ENKTL · Relapsed/Refractory

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT05700448

Prepared using TrialCompass (trialcompass.com) on June 19, 2026. For informational purposes only. Always discuss with your healthcare team.
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Data sourced from ClinicalTrials.gov.

For informational purposes only. Not medical advice — always consult your healthcare team.

Built with care for the rare cancer community.

Data last updated: June 2026

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