Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorOno Pharmaceutical Co., Ltd.
About this trial
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
Qualifiers
Patients aged ≥ 18 years at time of screening
Written informed consent by the patient or the patients' legally authorized representative prior to screening
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)
Cutaneous T-cell lymphoma (CTCL) (stages II-B, III, and IV): Mycosis fungoides (MF) and Sezary syndrome (SS)
Disqualifiers
Patients with central nervous system (CNS) involvement
Patients with Adult T-cell leukemia/lymphoma (ATLL)
Prior allogeneic stem cell transplant
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
Trial design
Treatments tested in this trial
- ONO-4685
Treatment groups
217 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov