Actively Recruiting
Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma
Led by Ono Pharmaceutical Co., Ltd. · Updated on 2026-02-13
217
Participants Needed
20
Research Sites
350 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ONO-4685 in patients with relapsed or refractory T cell Lymphoma
CONDITIONS
Official Title
Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 65 18 years at time of screening
- Written informed consent by the patient or the patients' legally authorized representative prior to screening
- Histologically or cytologically confirmed diagnosis of one of the following T-cell lymphoma subtypes: Peripheral T-cell lymphoma (Angioimmunoblastic T-cell lymphoma, PTCL not otherwise specified, nodal PTCL with T-follicular helper and follicular T-cell lymphoma) or Cutaneous T-cell lymphoma (stages II-B, III, and IV: Mycosis fungoides and Sezary syndrome)
- Received at least 2 prior systemic therapies
- For PTCL, at least 1 measurable lesion
- For CTCL, assessable disease by CTCL response criteria
- Eastern Cooperative Oncology Group Performance Status of 0 to 2
- Life expectancy of at least 3 months
- Adequate bone marrow, kidney, and liver function
You will not qualify if you...
- Central nervous system involvement
- Adult T-cell leukemia/lymphoma
- Prior allogeneic stem cell transplant
- Prior treatment with ONO-4685, anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies, or drugs targeting T-cell co-stimulation or checkpoint pathways
- Prior allogeneic or autologous CAR T-cell therapy
- Other malignancies except resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, or malignancies without relapse for at least 2 years
- History of severe allergy or hypersensitivity to monoclonal antibodies, therapeutic proteins, or corticosteroids
- Infection with Mycobacterium tuberculosis within 2 years before treatment start
- Systemic and active infections including HIV, hepatitis B or C
- Not recovered to Grade 1 or stabilized from adverse effects of prior cancer therapy (excluding hair loss)
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Completed
2
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
3
University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
4
Stanford Cancer Institute
Palo Alto, California, United States, 94304
Actively Recruiting
5
Yale Cancer Center
New Haven, Connecticut, United States, 06519
Actively Recruiting
6
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
7
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
8
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
9
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
10
Hackensack University Medical Center - John Theurer Cancer Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
11
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
12
New York-Presbyterian/Columbia University Irving Medical Center - Herbert Irving Comprehensive Cancer Center (HICCC)
New York, New York, United States, 10032
Actively Recruiting
13
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
14
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States, 28204
Actively Recruiting
15
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
16
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
17
University of Pennsylvania - Perelman Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
18
Vanderbilt University - Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
19
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
20
MD Anderson
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
N
North America Clinical Trial Support Desk
CONTACT
I
International Clinical Trial Support Desk
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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