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Phase 1RecruitingPriority 3 · Moderate priorityNCT05079282

Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma

ClinicalTrials.gov

Plain-language summary

This Phase 1 trial is testing ONO-4685 for people whose a type of T-cell lymphoma called AITL has come back or has not responded to previous treatment. The study starts with lower doses to find the safest effective dose before testing in more people. It is available at 20 US locations across multiple states.

Who can join (key eligibility)

  • Age 18 Years or older
  • 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

ONO-4685 (DRUG): ONO-4685 is administered by IV infusion. The administration of ONO-4685 will be continued until disease progression or unacceptable toxicity is observed

Drugs / treatments
ONO-4685
Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details
TrialCompass — Clinical Trial Summary

Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma

NCT05079282

Phase: Phase 1 | Status: Recruiting | Priority: Medium

Plain-language summary

This Phase 1 trial is testing ONO-4685 for people whose a type of T-cell lymphoma called AITL has come back or has not responded to previous treatment. The study starts with lower doses to find the safest effective dose before testing in more people. It is available at 20 US locations across multiple states.

Who can join

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

What's being tested

ONO-4685 (DRUG): ONO-4685 is administered by IV infusion. The administration of ONO-4685 will be continued until disease progression or unacceptable toxicity is observed

Drugs / treatments: ONO-4685

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Non-randomized, open-label

Enrollment target: 217 patients

Primary endpoint: Incidence, nature, and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs).; Estimate of Maximum Tolerate Dose (MTD)

Ages: 18 Years to —

Start date: 2021-12-10 | Est. completion: 2028-08-31

Locations

20 US sites · 20 total

Alabama, California, Connecticut, Georgia, Massachusetts, Michigan, Missouri, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas

Contact

North America Clinical Trial Support Desk | clinical_trial@ono-pharma.com | +18665877745(Toll-Free)

Sponsor: Ono Pharmaceutical Co., Ltd. (INDUSTRY)

Tags

AITL/TFH · ATLL · CTCL · PTCL-NOS · Relapsed/Refractory

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT05079282

Prepared using TrialCompass (trialcompass.com) on July 4, 2026. For informational purposes only. Always discuss with your healthcare team.