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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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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

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.

City, postcode or hospital

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

Other trials in Japan

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 groups in NCT06547528
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.

1 Oct 202330 Apr 2029

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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