Clinical trial · Interventional
A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL
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)
NCT06547528CI-TRIAL-00090474active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Summary
Brief summary (as posted)
A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ONO-4685 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ONO-4685
- interventionNames
- Drug: ONO-4685
Primary outcomes (14)
- measure
- Dose-limiting toxicities(DLT)
- timeFrame
- Up to 3 Weeks
- measure
- Incidence and severity of AEs and SAEs
- timeFrame
- Through study completion, an average of 1 year
- measure
- Laboratory abnormality profile of ONO-4685 as measured by incidence and severity of clinical laboratory abnormalities
- timeFrame
- Through study completion, an average of 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 investigator or subinvestigator 3. ECOG PS 0\~2 4. Life expectancy of at least 3 months Exclusion Criteria: 1. Patients with severe complications. 2. Patients with multiple cancers.
References
Publications (0)
Data not yet available
No reference posted for this study.