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)

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

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.