ONO-4685-05:A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL

ONO-4685-05: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)

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2011230051

Enrollment

108

Registered

2023-11-19

Start date

2023-11-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed or refractory T-cell lymphoma and chronic lymphocytic leukemia/small lymphocytic lymphoma

Interventions

ONO-4685 Given as Monotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.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) - Mycosis fungoides(MF) - Sezary syndrome Chronic lymphocytic leukemia/small lymphocytic lymphoma(CLL/SLL) 2.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 investigatoror subinvestigator 3.ECOG PS 0~2 4.Life expectancy of at least 3 months

Exclusion criteria

Exclusion criteria: 1.Patients with severe complications. 2.Patients with multiple cancers.

Design outcomes

Primary

Measure	Time frame
Safety and tolerability	—

Secondary

Measure	Time frame
Efficacy, pharmacokinetics and immunogenicity	—

Contacts

Public ContactSupport Desk JP

Ono Pharmaceutical Co.,LTD

clinical_trial@ono-pharma.com+81-120-278-120

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026