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NCT05079282 | RECRUITING | Relapsed or Refractory T Cell Lymphoma

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

Ono Pharmaceutical Co. Ltd

Brief Summary:

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

Condition or disease

Relapsed or Refractory T Cell Lymphoma

Intervention/treatment

ONO-4685

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 217 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2021-12-10
Estimated Primary Completion Date : 2026-03-31
Estimated Study Completion Date : 2027-03-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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 of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma

    Location Details

    NCT05079282

    Please Choose a site

    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    RECRUITING

    United States, alabama

    University of Alabama at Birmingham

    Birmingham, alabama, United States, 35294

    RECRUITING

    United States, California

    City of Hope

    Duarte, California, United States, 91010

    RECRUITING

    United States, California

    University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center

    Orange, California, United States, 92868

    RECRUITING

    United States, California

    Stanford Cancer Institute

    Palo Alto, California, United States, 94304

    RECRUITING

    United States, Connecticut

    Yale Cancer Center

    New Haven, Connecticut, United States, 06519

    RECRUITING

    United States, Georgia

    Winship Cancer Institute of Emory University

    Atlanta, Georgia, United States, 30322

    RECRUITING

    United States, Massachusetts

    Dana Farber Cancer Institute

    Boston, Massachusetts, United States, 02215

    RECRUITING

    United States, road cancer

    Karmanos Cancer Institute

    Detroit, road cancer, United States, 48201

    RECRUITING

    United States, New Jersey

    Hackensack University Medical Center - John Theurer Cancer Center

    Hackensack, New Jersey, United States, 07601

    RECRUITING

    United States, New York

    Roswell Park Cancer Institute

    Buffalo, New York, United States, 14263

    RECRUITING

    United States, New York

    New York-Presbyterian/Columbia University Irving Medical Center - Herbert Irving Comprehensive Cancer Center (HICCC)

    New York, New York, United States, 10032

    RECRUITING

    United States, New York

    Memorial Sloan-Kettering Cancer Center

    New York, New York, United States, 10065

    RECRUITING

    United States, North Carolina

    Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, United States, 28204

    RECRUITING

    United States, Ohio

    Cleveland Clinic

    Cleveland, Ohio, United States, 44195

    RECRUITING

    United States, Oregon

    Oregon Health & Science University

    Portland, Oregon, United States, 97239

    RECRUITING

    United States, Texas

    UT Southwestern Medical Center

    dallas, Texas, United States, 75390

    RECRUITING

    United States, Texas

    MD Anderson

    Houston, Texas, United States, 77030