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

NCT05079282 · Ono Pharmaceutical Co., Ltd.
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Official title
An Open-label, Multi-center, Non-randomized Phase I Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ONO-4685 Given as Monotherapy in Patients With Relapsed or Refractory T Cell Lymphoma
About this study
This study will investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ONO-4685 in patients with relapsed or refractory T cell Lymphoma
Eligibility criteria
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
Study design
Enrollment target: 217 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2021-12-10
Estimated completion: 2028-08-31
Last updated: 2026-02-13
Interventions
Drug: ONO-4685
Primary outcomes
  • 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)
  • Estimate of Maximum Tolerate Dose (MTD) (Up to 3 weeks)
Sponsor
Ono Pharmaceutical Co., Ltd. · industry
Contacts & investigators
ContactNorth America Clinical Trial Support Desk · contact · clinical_trial@ono-pharma.com · +18665877745(Toll-Free)
ContactInternational Clinical Trial Support Desk · contact · clinical_trial@ono-pharma.com · +17162141777(Standard)
InvestigatorProject Leader · study_director, Ono Pharmaceutical Co., Ltd.
All locations (20)
University of Alabama at BirminghamCompleted
Birmingham, Alabama, United States
City of HopeRecruiting
Duarte, California, United States
University of California Irvine Medical Center - Chao Family Comprehensive Cancer CenterRecruiting
Orange, California, United States
Stanford Cancer InstituteRecruiting
Palo Alto, California, United States
Yale Cancer CenterRecruiting
New Haven, Connecticut, United States
Winship Cancer Institute of Emory UniversityRecruiting
Atlanta, Georgia, United States
Dana Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Karmanos Cancer InstituteRecruiting
Detroit, Michigan, United States
Washington University School of Medicine in St. LouisRecruiting
St Louis, Missouri, United States
Hackensack University Medical Center - John Theurer Cancer CenterRecruiting
Hackensack, New Jersey, United States
Roswell Park Cancer InstituteRecruiting
Buffalo, New York, United States
New York-Presbyterian/Columbia University Irving Medical Center - Herbert Irving Comprehensive Cancer Center (HICCC)Recruiting
New York, New York, United States
Memorial Sloan-Kettering Cancer CenterRecruiting
New York, New York, United States
Novant Health Presbyterian Medical CenterRecruiting
Charlotte, North Carolina, United States
Cleveland ClinicRecruiting
Cleveland, Ohio, United States
Oregon Health & Science UniversityRecruiting
Portland, Oregon, United States
University of Pennsylvania - Perelman CenterRecruiting
Philadelphia, Pennsylvania, United States
Vanderbilt University - Ingram Cancer CenterRecruiting
Nashville, Tennessee, United States
UT Southwestern Medical CenterRecruiting
Dallas, Texas, United States
MD AndersonRecruiting
Houston, Texas, United States
Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma · TrialPath