UAB - Center for Clinical and Translational Science

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

Purpose

This study will investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ONO-4685 in patients with relapsed or refractory T cell Lymphoma

Condition

Relapsed or Refractory T Cell Lymphoma

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Patients aged ≥ 18 years at time of screening 2. Written informed consent by the patient or the patients' legally authorized representative prior to screening 3. Patients with histologically or cytologically confirmed diagnosis of one of the following subtypes of T-cell lymphoma: 1. Peripheral T-cell lymphoma (PTCL): Angioimmunoblastic T-cell lymphoma (AITL), PTCL, not otherwise specified (PTCL-NOS), nodal PTCL with T-follicular helper (TFH) and follicular T-cell lymphoma (FTCL) 2. Cutaneous T-cell lymphoma (CTCL) (stages II-B, III, and IV): Mycosis fungoides (MF) and Sezary syndrome (SS) 4. Patients must have received at least 2 prior systemic therapies. 5. Patients with PTCL must have at least 1 measurable lesion 6. Patients with CTCL must have assessable disease by response criteria for CTCL (Olsen EA, 2011) 7. Eastern Cooperative Oncology Group Performance Status (ECOG PS) = 0-2 8. Life expectancy of at least 3 months 9. Adequate bone marrow, renal and hepatic functions

Exclusion Criteria

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. 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 6. History of severe allergy or hypersensitivity to any monoclonal antibodies, other therapeutic proteins or corticosteroid (e.g., dexamethasone) 7. History of infection with Mycobacterium tuberculosis within 2 years prior to the first dose of study treatment 8. Patients with systemic and active infection including human immunodeficiency virus (HIV), hepatitis B or C virus infection 9. Patients not recovered to Grade 1 or stabilized from the adverse effects (excluding alopecia) of any prior therapy for their malignancies 10. Women who are pregnant or lactating

Study Design

Phase: Phase 1
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental ONO-4685 monotherapy	Patients with relapsed or refractory T cell Lymphoma who meet eligibility criteria will be enrolled to receive ONO-4685 monotherapy	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

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294

More Details

Status: Recruiting
Sponsor: Ono Pharmaceutical Co. Ltd

Study Contact

Ono Pharma USA, Inc.
clinical_trial@ono-pharma.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.