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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
ONO-4685
DrugONO-4685 is administered by IV infusion. The administration of ONO-4685 will be continued until disease progression or unacceptable toxicity is observed
Treatment groups
217 Participants
are divided into 1 treatment groupGroup A: ONO-4685 monotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence, nature, and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs).
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.
Time frame
Through study completion, an average of 1 year2
Estimate of Maximum Tolerate Dose (MTD)
MTD will be estimated based on Dose limiting toxicity (DLT) observed during the first 3 weeks of treatment
Time frame
Up to 3 weeksSecondary outcomes
1
Plasma Concentration of ONO-4685
Plasma concentration will be assessed to evaluate Pharmacokinetics
Time frame
Up to 48 weeks2
Plasma Concentration of Anti-Drug Antibody (ADA)
ADA to ONO-4685 will be assessed to evaluate potential immunogenicity.
Time frame
Up to 48 weeks3
Antitumor Activity of ONO-4685
Antitumor Activity of ONO-4685 will be assessed according to the response criteria for Lymphoma.
Time frame
Through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov