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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

Phase
Phase 1
Sponsor
Ono Pharmaceutical Co. Ltd
Enrollment
217
Timeline
Dec 2021 → Mar 2027
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

  • 1Patients aged ≥ 18 years at time of screening
  • 2Written informed consent by the patient or the patients' legally authorized representative prior to screening
  • 3Patients with histologically or cytologically confirmed diagnosis of one of the following subtypes of T-cell lymphoma:
  • 4Peripheral 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)
  • 5Cutaneous T-cell lymphoma (CTCL) (stages II-B, III, and IV): Mycosis fungoides (MF) and Sezary syndrome (SS)
  • 6Patients must have received at least 2 prior systemic therapies
  • 7Patients with PTCL must have at least 1 measurable lesion (Cheson BD, 2014)
  • 8Patients with CTCL must have assessable disease by response criteria for CTCL (Olsen EA, 2011)
  • 9Eastern Cooperative Oncology Group Performance Status (ECOG PS) = 0-2
  • 10Life expectancy of at least 3 months
  • 11Adequate bone marrow, renal and hepatic functions

Exclusion Criteria

  • 1Patients with central nervous system (CNS) involvement
  • 2Patients with Adult T-cell leukemia/lymphoma (ATLL)
  • 3Prior allogeneic stem cell transplant
  • 4Prior 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
  • 5Prior allogeneic and autologous chimeric antigen receptor (CAR) T-cell therapy
  • 6Patients 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
  • 7History of severe allergy or hypersensitivity to any monoclonal antibodies, other therapeutic proteins or corticosteroid (e.g., dexamethasone)
  • 8History of infection with Mycobacterium tuberculosis within 2 years prior to the first dose of study treatment
  • 9Patients with systemic and active infection including human immunodeficiency virus (HIV), hepatitis B or C virus infection
  • 10Patients not recovered to Grade 1 or stabilized from the adverse effects (excluding alopecia) of any prior therapy for their malignancies
  • 11Women who are pregnant or lactating

Locations

17 sites participating in this study

Winship Cancer Institute of Emory University

Atlanta, Georgia 30322

Recruiting

University of Alabama at Birmingham

Birmingham, Alabama 35294

Recruiting

City of Hope

Duarte, California 91010

Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →