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Phase 1RecruitingPriority 4 · Lower priorityNCT06547528

A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL

ClinicalTrials.gov

Plain-language summary

This trial is testing ONO-4685 (an investigational intravenous drug) for patients with various types of peripheral T-cell lymphoma (PTCL) whose disease has come back or stopped responding to prior treatment. This is a Phase 1 trial, which means researchers are finding the right dose and this is among the earliest testing in patients. This trial does not currently have sites in the United States. The trial is currently recruiting patients.

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.

  • ONO-4685

Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details

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TrialCompass — Clinical Trial Summary

A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL

NCT06547528

Phase: Phase 1 | Status: Recruiting | Priority: Lower

Plain-language summary

This trial is testing ONO-4685 (an investigational intravenous drug) for patients with various types of peripheral T-cell lymphoma (PTCL) whose disease has come back or stopped responding to prior treatment. This is a Phase 1 trial, which means researchers are finding the right dose and this is among the earliest testing in patients. This trial does not currently have sites in the United States. The trial is currently recruiting patients.

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: 108 patients

Primary endpoint: Dose-limiting toxicities(DLT); Incidence and severity of AEs and SAEs; Laboratory abnormality profile of ONO-4685 as measured by incidence and severity of clinical laboratory abnormalities; Body temperature; Pulse rate; Systolic/diastolic blood pressure; Change of weight during the trial period; Chest X-ray test; ECG parameters by 12 lead ECG(pulse rate); ECG parameters by 12 lead ECG(RR); ECG parameters by 12 lead ECG(QT interval); ECG parameters by 12 lead ECG(corrected QT intervals [QTcF, QTcB]); ECG parameters by 12 lead ECG(PR interval); ECG parameters by 12 lead ECG(QRS)

Ages: 18 Years to —

Start date: 2023-10-01 | Est. completion: 2029-04-30

Locations

0 US sites · 14 total

Contact

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

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

Tags

All T-cell lymphomas · Relapsed/Refractory

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT06547528

Prepared using TrialCompass (trialcompass.com) on August 18, 2026. For informational purposes only. Always discuss with your healthcare team.