Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma
NCT ID: NCT05079282
Last Updated: 2025-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
217 participants
INTERVENTIONAL
2021-12-10
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ONO-4685 monotherapy
Patients with relapsed or refractory T cell Lymphoma who meet eligibility criteria will be enrolled to receive ONO-4685 monotherapy
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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 (Cheson BD, 2014)
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
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
18 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Project Leader
Role: STUDY_DIRECTOR
Ono Pharmaceutical Co. Ltd
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
City of Hope
Duarte, California, United States
University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center
Orange, California, United States
Stanford Cancer Institute
Palo Alto, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Hackensack University Medical Center - John Theurer Cancer Center
Hackensack, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
New York-Presbyterian/Columbia University Irving Medical Center - Herbert Irving Comprehensive Cancer Center (HICCC)
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
UT Southwestern Medical Center
Dallas, Texas, United States
MD Anderson
Houston, Texas, United States
Countries
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Central Contacts
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Other Identifiers
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ONO-4685-03
Identifier Type: -
Identifier Source: org_study_id
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