A Phase I Study of ONO-4685 Immunotherapy in People with T-Cell Lymphoma


Full Title

An Open-label, Multi-center, Non-randomized Phase I Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ONO-4685 Given as Monotherapy in Patients with Relapsed or Refractory T-cell Lymphoma


The purpose of this study is to find the highest dose of the investigational drug ONO-4685 that can be given safely in people with cutaneous T-cell lymphoma (CTCL) or peripheral T-cell lymphoma (PTCL) that came back or continued to grow despite treatment. ONO-4685 may strengthen the immune system’s ability to fight cancer cells by activating a patient’s own cells to destroy the tumor. It is given intravenously (by vein).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have CTCL or PTCL that came back or continued to grow despite two or more prior regimens of treatment.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 18 and older.

For more information and to ask about eligibility for this study, please contact 646-608-2680.




Phase I (phase 1)

Disease Status

Newly Diagnosed & Relapsed/Refractory



ClinicalTrials.gov ID