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
Study summary
This study will investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ONO-4685 in patients with relapsed or refractory T cell Lymphoma
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria
1. 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 (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:
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
Primary outcome measure(s)
Incidence, nature, and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs). — Through study completion, an average of 1 year Adverse events with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 used as a guide for the grading of severity.
Estimate of Maximum Tolerate Dose (MTD) — Up to 3 weeks MTD will be estimated based on Dose limiting toxicity (DLT) observed during the first 3 weeks of treatment
Trial sites (20)
Facility
City
Region
Status
University of Alabama at Birmingham
Birmingham
Alabama
Completed
City of Hope
Duarte
California
Recruiting
University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center
Orange
California
Recruiting
Stanford Cancer Institute
Palo Alto
California
Recruiting
Yale Cancer Center
New Haven
Connecticut
Recruiting
Winship Cancer Institute of Emory University
Atlanta
Georgia
Recruiting
Dana Farber Cancer Institute
Boston
Massachusetts
Recruiting
Karmanos Cancer Institute
Detroit
Michigan
Recruiting
Washington University School of Medicine in St. Louis
St Louis
Missouri
Recruiting
Hackensack University Medical Center - John Theurer Cancer Center
Hackensack
New Jersey
Recruiting
Roswell Park Cancer Institute
Buffalo
New York
Recruiting
New York-Presbyterian/Columbia University Irving Medical Center - Herbert Irving Comprehensive Cancer Center (HICCC)
New York
New York
Recruiting
Memorial Sloan-Kettering Cancer Center
New York
New York
Recruiting
Novant Health Presbyterian Medical Center
Charlotte
North Carolina
Recruiting
Cleveland Clinic
Cleveland
Ohio
Recruiting
Oregon Health & Science University
Portland
Oregon
Recruiting
University of Pennsylvania - Perelman Center
Philadelphia
Pennsylvania
Recruiting
Vanderbilt University - Ingram Cancer Center
Nashville
Tennessee
Recruiting
UT Southwestern Medical Center
Dallas
Texas
Recruiting
MD Anderson
Houston
Texas
Recruiting
More Ono Pharmaceutical Co., Ltd. trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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