Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaPhase 1NCT06547528
A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL
A Phase 1 study testing ONO-4685 in people with Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, run by Ono Pharmaceutical Co., Ltd. at 14 sites in Japan.
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 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 and Chronic Lymphocytic Leukemia/Small Lymphocytic 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
- 108 participants
- Where
- 14 sitesJapan
- Study dates
- 1 Oct 2023to 30 Apr 2029
- 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 with histopathologically confirmed diagnosis of one of the following subtypes as defined by the 2017 revision of the WHO classification of lymphoid malignancies:
- Peripheral T-cell lymphoma(PTCL)
- Angioimmunoblastic T-cell lymphoma(AITL)
- Peripheral T-cell lymphoma, NOS(PTCL-NOS)
- Nodal peripheral T-cell lymphoma with TFH phenotype(nodal PTCL with TFH)
- Follicular T-cell lymphoma(FTCL) Cutaneous T-cell lymphoma(CTCL)
Show all 11Show fewer
- Mycosis fungoides(MF)
- Sezary syndrome Chronic lymphocytic leukemia/small lymphocytic lymphoma(CLL/SLL)
- Relapsed or refractory patients with tumors for which no established standard therapy is available, or refractory or intolerant to existing standard therapy judged by principal investigator or subinvestigator
- ECOG PS 0~2
- Life expectancy of at least 3 months
Who cannot join
- Patients with severe complications.
- Patients with multiple cancers.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Japan14 sites
Akita University Hospital
Akita, Akita
Kyushu University Hospital
Fukuoka, Fukuoka
Tokai University Hospital
Isehara-shi, Kanagawa
National Cancer Center Hospital East
Kashiwa-shi, Chiba
Cancer Institute Hospital of JFCR
Koto-ku, Tokyo
Kumamoto University Hospital
Kumamoto, Kumamoto
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Kyoto
Aichi Cancer Center Hospital
Nagoya, Aichi-ken
Nagoya University Hospital
Nagoya, Aichi-ken
Okayama University Hospital
Okayama, Okayama-ken
Kindai University Hospital
Osaka Sayama-shi, Osaka
Osaka University Hospital
Osaka-fu, Osaka
Hokkaido University Hospital
Sapporo, Hokkaido
Tohoku University Hospital
Sendai, Miyagi
About this study
Official title: An Open-label, Uncontrolled, Phase I Dose Escalation Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in Patients With Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL
- Conditions
- Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- Being tested
- ONO-4685
- Medical subject headings
- Recurrence, Lymphoma, T-Cell, Leukemia, Lymphocytic, Chronic, B-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 | Experimental | Not described Receives: Drug: ONO-4685 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities(DLT)
Measured: Up to 3 Weeks
Incidence and severity of AEs and SAEs
Measured: Through study completion, an average of 1 year
Laboratory abnormality profile of ONO-4685 as measured by incidence and severity of clinical laboratory abnormalities
Measured: Through study completion, an average of 1 year
Body temperature
Measured: Through study completion, an average of 1 year
Pulse rate
Measured: Through study completion, an average of 1 year
Systolic/diastolic blood pressure
Measured: Through study completion, an average of 1 year
Change of weight during the trial period
Measured: Through study completion, an average of 1 year
Chest X-ray test
Measured: Through study completion, an average of 1 year
ECG parameters by 12 lead ECG(pulse rate)
Measured: Through study completion, an average of 1 year
ECG parameters by 12 lead ECG(RR)
Measured: Through study completion, an average of 1 year
ECG parameters by 12 lead ECG(QT interval)
Measured: Through study completion, an average of 1 year
ECG parameters by 12 lead ECG(corrected QT intervals [QTcF, QTcB])
Measured: Through study completion, an average of 1 year
ECG parameters by 12 lead ECG(PR interval)
Measured: Through study completion, an average of 1 year
ECG parameters by 12 lead ECG(QRS)
Measured: Through study completion, an average of 1 year
Secondary outcomes (17)
Best overall response (BOR)
Measured: Through study completion, an average of 1 year
Overall response rate (ORR)
Measured: Through study completion, an average of 1 year
Complete response rate (CRR)
Measured: Through study completion, an average of 1 year
Duration of response (DOR)
Measured: Through study completion, an average of 1 year
Progression Free Survival(PFS)
Measured: Through study completion, an average of 1 year
Time to response (TTR)
Measured: Through study completion, an average of 1 year
Overall Survival(OS)
Measured: Through study completion, an average of 1 year
The percent change of tumor volume
Measured: Through study completion, an average of 1 year
Pharmacokinetics(Cmax)
Measured: Through study completion, an average of 1 year
Pharmacokinetics(Tmax)
Measured: Through study completion, an average of 1 year
Pharmacokinetics(AUC)
Measured: Through study completion, an average of 1 year
Pharmacokinetics(Ceoi)
Measured: Through study completion, an average of 1 year
Pharmacokinetics(T1/2)
Measured: Through study completion, an average of 1 year
Pharmacokinetics(Ctrough)
Measured: Through study completion, an average of 1 year
Volume of distribution(Vd)
Measured: Through study completion, an average of 1 year
clearance(CL)
Measured: Through study completion, an average of 1 year
Anti-ONO-4685 antibody
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 posted9 Aug 2024
- Study start1 Oct 2023
- Primary completion31 Jan 2029 (estimated)
- Study completion30 Apr 2029 (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 Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic 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
- 108 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
- NCT06547528
- Sponsor's protocol ID
- ONO-4685-05
- Other IDs
- jRCT2011230051
- Status last verified
- Sep 2026
- First submitted
- 1 Aug 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Uncontrolled, Phase I Dose Escalation Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in Patients With Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
- ClinicalTrials.gov ID
- NCT06547528
- Acronym / sponsor ID
- ONO-4685-05
- Conditions
- Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 9 Aug 2024 (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.
A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL
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 | Experimental | Drug: ONO-4685 |
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 with histopathologically confirmed diagnosis of one of the following subtypes as defined by the 2017 revision of the WHO classification of lymphoid malignancies:
- Peripheral T-cell lymphoma(PTCL)
- Relapsed or refractory patients with tumors for which no established standard therapy is available, or refractory or intolerant to existing standard therapy judged by principal investigator or subinvestigator
- ECOG PS 0~2
- Life expectancy of at least 3 months
Key exclusion criteria (2 listed)
- Patients with severe complications.
- Patients with multiple cancers.
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 |
Primary outcome
Dose-limiting toxicities(DLT)
Time frame: Up to 3 Weeks
Incidence and severity of AEs and SAEs
Time frame: Through study completion, an average of 1 year
Laboratory abnormality profile of ONO-4685 as measured by incidence and severity of clinical laboratory abnormalities
Time frame: Through study completion, an average of 1 year
Body temperature
Time frame: Through study completion, an average of 1 year
Pulse rate
Time frame: Through study completion, an average of 1 year
Systolic/diastolic blood pressure
Time frame: Through study completion, an average of 1 year
Change of weight during the trial period
Time frame: Through study completion, an average of 1 year
Chest X-ray test
Time frame: Through study completion, an average of 1 year
ECG parameters by 12 lead ECG(pulse rate)
Time frame: Through study completion, an average of 1 year
ECG parameters by 12 lead ECG(RR)
Time frame: Through study completion, an average of 1 year
ECG parameters by 12 lead ECG(QT interval)
Time frame: Through study completion, an average of 1 year
ECG parameters by 12 lead ECG(corrected QT intervals [QTcF, QTcB])
Time frame: Through study completion, an average of 1 year
ECG parameters by 12 lead ECG(PR interval)
Time frame: Through study completion, an average of 1 year
ECG parameters by 12 lead ECG(QRS)
Time frame: Through study completion, an average of 1 year
17 secondary outcomes
Best overall response (BOR)
Time frame: Through study completion, an average of 1 year
Overall response rate (ORR)
Time frame: Through study completion, an average of 1 year
Complete response rate (CRR)
Time frame: Through study completion, an average of 1 year
Duration of response (DOR)
Time frame: Through study completion, an average of 1 year
Progression Free Survival(PFS)
Time frame: Through study completion, an average of 1 year
Time to response (TTR)
Time frame: Through study completion, an average of 1 year
Overall Survival(OS)
Time frame: Through study completion, an average of 1 year
The percent change of tumor volume
Time frame: Through study completion, an average of 1 year
Pharmacokinetics(Cmax)
Time frame: Through study completion, an average of 1 year
Pharmacokinetics(Tmax)
Time frame: Through study completion, an average of 1 year
Pharmacokinetics(AUC)
Time frame: Through study completion, an average of 1 year
Pharmacokinetics(Ceoi)
Time frame: Through study completion, an average of 1 year
Pharmacokinetics(T1/2)
Time frame: Through study completion, an average of 1 year
Pharmacokinetics(Ctrough)
Time frame: Through study completion, an average of 1 year
Volume of distribution(Vd)
Time frame: Through study completion, an average of 1 year
clearance(CL)
Time frame: Through study completion, an average of 1 year
Anti-ONO-4685 antibody
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 28 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.
14 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 and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, run by Ono Pharmaceutical Co., Ltd. at 14 sites in Japan.
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 2 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 28 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 14 sites in Japan. 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?
Dose-limiting toxicities(DLT) (time frame: Up to 3 Weeks). The study lists 14 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 28 Sep 2026.