A Phase 1 interventional study of ONO-4685 in Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, sponsored by Ono Pharmaceutical Co., Ltd.. Active, not recruiting at 14 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Ono Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment
A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL
310 studies on the registry are indexed under Lymphoma, T-Cell; 78 are open to participants now.
This study's planned enrollment of 108 is above the median of 37 across 270 interventional studies indexed under Lymphoma, T-Cell.
Browse Lymphoma, T-Cell studies →Ono Pharmaceutical Co., Ltd. is the lead sponsor of 49 studies on the registry; 18 are open to participants now.
Compared within Lymphoma, T-Cell, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Recurrence. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients with histopathologically confirmed diagnosis of one of the following subtypes as defined by the 2017 revision of the WHO classification of lymphoid :
Peripheral T-cell lymphoma(PTCL)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: ONO-4685
ONO-4685 is administered by IV infusion. The administration of ONO-4685 will be continued until disease progression or unacceptable toxicity is observed.
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
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
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Besufetamig
Ono Pharmaceutical Co., Ltd. →