Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma

Exclusion Criteria

• •1. Patients with central nervous system (CNS) involvement
• •2. Patients with Adult T-cell leukemia/lymphoma (ATLL)
• •3. Prior allogeneic stem cell transplant
• •4. Prior treatment with ONO-4685, anti-PD-1, anti-PD-L1, anticytotoxic T lymphocyte associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
• •5. Prior allogeneic and autologous chimeric antigen receptor (CAR) T-cell therapy
• •6. Patients with malignancies (other than T-cell lymphoma) except for completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, or any other malignancies that has not relapsed for at least 2 years
• •7. History of severe allergy or hypersensitivity to any monoclonal antibodies, other therapeutic proteins or corticosteroid (e.g., dexamethasone)
• •8. History of infection with Mycobacterium tuberculosis within 2 years prior to the first dose of study treatment
• •9. Patients with systemic and active infection including human immunodeficiency virus (HIV), hepatitis B or C virus infection
• •10. Patients not recovered to Grade 1 or stabilized from the adverse effects (excluding alopecia) of any prior therapy for their malignancies
• •11. Women who are pregnant or lactating