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Investigating ONO-4685 for patients with relapsed or refractory T cell lymphoma

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

PHASE1 · Ono Pharmaceutical Co., Ltd. · NCT05079282

This study is testing a new treatment called ONO-4685 to see if it can help people with relapsed or hard-to-treat T cell lymphoma feel better.

Quick facts

PhasePHASE1
Study typeInterventional
Enrollment217 (estimated)
Ages18 Years and up
SexAll
SponsorOno Pharmaceutical Co., Ltd. (industry)
Drugs / interventionschimeric antigen receptor
Locations20 sites (Birmingham, Alabama and 19 other locations)
Trial IDNCT05079282 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, pharmacokinetics, and preliminary efficacy of ONO-4685, a bispecific antibody targeting PD-1 and CD3, in patients suffering from relapsed or refractory T cell lymphoma. Participants must have a confirmed diagnosis of specific subtypes of T-cell lymphoma and have undergone at least two prior systemic therapies. The study aims to gather data on how well this treatment works and its potential side effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with relapsed or refractory T cell lymphoma who have received at least two prior systemic therapies.

Not a fit: Patients with early-stage T cell lymphoma or those who have not received prior systemic therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat T cell lymphoma.

How similar studies have performed: Other studies involving bispecific antibodies have shown promise in treating various cancers, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria

1. Patients aged ≥ 18 years at time of screening
2. Written informed consent by the patient or the patients' legally authorized representative prior to screening
3. Patients with histologically or cytologically confirmed diagnosis of one of the following subtypes of T-cell lymphoma:

   1. Peripheral T-cell lymphoma (PTCL): Angioimmunoblastic T-cell lymphoma (AITL), PTCL, not otherwise specified (PTCL-NOS), nodal PTCL with T-follicular helper (TFH) and follicular T-cell lymphoma (FTCL)
   2. Cutaneous T-cell lymphoma (CTCL) (stages II-B, III, and IV): Mycosis fungoides (MF) and Sezary syndrome (SS)
4. Patients must have received at least 2 prior systemic therapies
5. Patients with PTCL must have at least 1 measurable lesion (Cheson BD, 2014)
6. Patients with CTCL must have assessable disease by response criteria for CTCL (Olsen EA, 2011)
7. Eastern Cooperative Oncology Group Performance Status (ECOG PS) = 0-2
8. Life expectancy of at least 3 months
9. Adequate bone marrow, renal and hepatic functions

Exclusion Criteria:

1. Patients with central nervous system (CNS) involvement
2. Patients with Adult T-cell leukemia/lymphoma (ATLL)
3. Prior allogeneic stem cell transplant
4. Prior treatment with ONO-4685, anti-PD-1, anti-PD-L1, anticytotoxic T lymphocyte associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
5. Prior allogeneic and autologous chimeric antigen receptor (CAR) T-cell therapy
6. Patients with malignancies (other than T-cell lymphoma) except for completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, or any other malignancies that has not relapsed for at least 2 years
7. History of severe allergy or hypersensitivity to any monoclonal antibodies, other therapeutic proteins or corticosteroid (e.g., dexamethasone)
8. History of infection with Mycobacterium tuberculosis within 2 years prior to the first dose of study treatment
9. Patients with systemic and active infection including human immunodeficiency virus (HIV), hepatitis B or C virus infection
10. Patients not recovered to Grade 1 or stabilized from the adverse effects (excluding alopecia) of any prior therapy for their malignancies
11. Women who are pregnant or lactating

Where this trial is running

Birmingham, Alabama and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Relapsed or Refractory T Cell Lymphoma, ONO-4685, PD-1, CD3, Bispecific antibody, PTCL, AITL, PTCL-NOS

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.