Relapsed or Refractory T Cell LymphomaPhase 1NCT05079282
Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma
A Phase 1 study testing ONO-4685 in people with Relapsed or Refractory T Cell Lymphoma, run by Ono Pharmaceutical Co., Ltd. at 21 sites in United States.
Trial summary
This study will investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ONO-4685 in patients with relapsed or refractory T cell Lymphoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory T Cell Lymphoma
- What is being tested?
- ONO-4685
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 21 sitesUnited States
- Study dates
- 10 Dec 2021to 31 Aug 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥ 18 years at time of screening
- Written informed consent by the patient or the patients' legally authorized representative prior to screening
- Patients with histologically or cytologically confirmed diagnosis of one of the following subtypes of T-cell lymphoma:
- 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)
- Cutaneous T-cell lymphoma (CTCL) (stages II-B, III, and IV): Mycosis fungoides (MF) and Sezary syndrome (SS)
- Patients must have received at least 2 prior systemic therapies
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- Patients with PTCL must have at least 1 measurable lesion (Cheson BD, 2014)
- Patients with CTCL must have assessable disease by response criteria for CTCL (Olsen EA, 2011)
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) = 0-2
- Life expectancy of at least 3 months
- Adequate bone marrow, renal and hepatic functions
Who cannot join
- Patients with central nervous system (CNS) involvement
- Patients with Adult T-cell leukemia/lymphoma (ATLL)
- Prior allogeneic stem cell transplant
- 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
- Prior allogeneic and autologous chimeric antigen receptor (CAR) T-cell therapy
- 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
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- History of severe allergy or hypersensitivity to any monoclonal antibodies, other therapeutic proteins or corticosteroid (e.g., dexamethasone)
- History of infection with Mycobacterium tuberculosis within 2 years prior to the first dose of study treatment
- Patients with systemic and active infection including human immunodeficiency virus (HIV), hepatitis B or C virus infection
- Patients not recovered to Grade 1 or stabilized from the adverse effects (excluding alopecia) of any prior therapy for their malignancies
- Women who are pregnant or lactating
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Roswell Park Cancer Institute
Buffalo, New York, 14263
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204
Cleveland Clinic
Cleveland, Ohio, 44195
UT Southwestern Medical Center
Dallas, Texas, 75390
Karmanos Cancer Institute
Detroit, Michigan, 48201
City of Hope
Duarte, California, 91010
Hackensack University Medical Center - John Theurer Cancer Center
Hackensack, New Jersey, 07601
MD Anderson
Houston, Texas, 77030
Vanderbilt University - Ingram Cancer Center
Nashville, Tennessee, 37232
Yale Cancer Center
New Haven, Connecticut, 06519
New York-Presbyterian/Columbia University Irving Medical Center - Herbert Irving Comprehensive Cancer Center (HICCC)
New York, New York, 10032
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center
Orange, California, 92868
Stanford Cancer Institute
Palo Alto, California, 94304
University of Pennsylvania - Perelman Center
Philadelphia, Pennsylvania, 19104
Oregon Health & Science University
Portland, Oregon, 97239
Fred Hutchinson Cancer Center
Seattle, Washington, 91809
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110
About this study
Official 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
This study will investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ONO-4685 in patients with relapsed or refractory T cell Lymphoma
- Conditions
- Relapsed or Refractory T Cell Lymphoma
- Being tested
- ONO-4685
- Keywords
- ONO-4685, PD-1, CD3, Bispecific antibody, PTCL, AITL, PTCL-NOS, nodal PTCL with TFH, FTCL, CTCL, MF, SS
- Medical subject headings
- Recurrence, Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-4685Drug
ONO-4685 is administered by IV infusion. The administration of ONO-4685 will be continued until disease progression or unacceptable toxicity is observed
| Study group | Role | What they receive |
|---|---|---|
| ONO-4685 monotherapy | Experimental | Patients with relapsed or refractory T cell Lymphoma who meet eligibility criteria will be enrolled to receive ONO-4685 monotherapy Receives: Drug: ONO-4685 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, nature, and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs).
Adverse events with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 used as a guide for the grading of severity.
Measured: Through study completion, an average of 1 year
Estimate of Maximum Tolerate Dose (MTD)
MTD will be estimated based on Dose limiting toxicity (DLT) observed during the first 3 weeks of treatment
Measured: Up to 3 weeks
Secondary outcomes (3)
Plasma Concentration of ONO-4685
Plasma concentration will be assessed to evaluate Pharmacokinetics
Measured: Up to 48 weeks
Plasma Concentration of Anti-Drug Antibody (ADA)
ADA to ONO-4685 will be assessed to evaluate potential immunogenicity.
Measured: Up to 48 weeks
Antitumor Activity of ONO-4685
Antitumor Activity of ONO-4685 will be assessed according to the response criteria for Lymphoma.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start10 Dec 2021
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory T Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 217 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Project Leader, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079282
- Sponsor's protocol ID
- ONO-4685-03
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2021
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05079282
- Acronym / sponsor ID
- ONO-4685-03
- Conditions
- Relapsed or Refractory T Cell Lymphoma
- Keywords
- ONO-4685, PD-1, CD3, Bispecific antibody, PTCL, AITL, PTCL-NOS, nodal PTCL with TFH
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 217 participants (estimated)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ONO-4685 in patients with relapsed or refractory T cell Lymphoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ONO-4685 monotherapy | Experimental | Drug: ONO-4685Patients with relapsed or refractory T cell Lymphoma who meet eligibility criteria will be enrolled to receive ONO-4685 monotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients aged ≥ 18 years at time of screening
- Written informed consent by the patient or the patients' legally authorized representative prior to screening
- Patients with histologically or cytologically confirmed diagnosis of one of the following subtypes of T-cell lymphoma:
- Patients must have received at least 2 prior systemic therapies
- Patients with PTCL must have at least 1 measurable lesion (Cheson BD, 2014)
Key exclusion criteria (11 listed)
- Patients with central nervous system (CNS) involvement
- Patients with Adult T-cell leukemia/lymphoma (ATLL)
- Prior allogeneic stem cell transplant
- 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
- Prior allogeneic and autologous chimeric antigen receptor (CAR) T-cell therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONO-4685ONO-4685 is administered by IV infusion. The administration of ONO-4685 will be continued until disease progression or unacceptable toxicity is observed | Drug | ONO-4685 monotherapy |
Primary outcome
Incidence, nature, and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs).
Time frame: Through study completion, an average of 1 year
Adverse events with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 used as a guide for the grading of severity.
Estimate of Maximum Tolerate Dose (MTD)
Time frame: Up to 3 weeks
MTD will be estimated based on Dose limiting toxicity (DLT) observed during the first 3 weeks of treatment
3 secondary outcomes
Plasma Concentration of ONO-4685
Time frame: Up to 48 weeks
Plasma Concentration of Anti-Drug Antibody (ADA)
Time frame: Up to 48 weeks
Antitumor Activity of ONO-4685
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Project Leader study director
Ono Pharmaceutical Co., Ltd.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ONO-4685 in people with Relapsed or Refractory T Cell Lymphoma, run by Ono Pharmaceutical Co., Ltd. at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, nature, and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs). (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.