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

Ono Pharmaceutical Co. Ltd20 sites in 1 country217 target enrollmentDecember 10, 2021

ConditionsRelapsed or Refractory T Cell Lymphoma

InterventionsONO-4685

Overview

Phase: Phase 1
Intervention: ONO-4685
Conditions: Relapsed or Refractory T Cell Lymphoma
Sponsor: Ono Pharmaceutical Co. Ltd
Enrollment: 217
Locations: 20
Primary Endpoint: Estimate of Maximum Tolerate Dose (MTD)
Status: Recruiting
Last Updated: 2 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

December 10, 2021

End Date

August 31, 2028

Last Updated

2 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Ono Pharmaceutical Co. Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients aged ≥ 18 years at time of screening
•Written informed consent by the patient or the patients' legally authorized representative prior to screening
•Patients with histologically or cytologically confirmed diagnosis of one of the following subtypes of T-cell lymphoma:
•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)
•Patients must have received at least 2 prior systemic therapies
•Patients with PTCL must have at least 1 measurable lesion (Cheson BD, 2014)
•Patients with CTCL must have assessable disease by response criteria for CTCL (Olsen EA, 2011)
•Eastern Cooperative Oncology Group Performance Status (ECOG PS) = 0-2
•Life expectancy of at least 3 months

Exclusion Criteria

•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
•Prior allogeneic and autologous chimeric antigen receptor (CAR) T-cell therapy
•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
•History of severe allergy or hypersensitivity to any monoclonal antibodies, other therapeutic proteins or corticosteroid (e.g., dexamethasone)
•History of infection with Mycobacterium tuberculosis within 2 years prior to the first dose of study treatment
•Patients with systemic and active infection including human immunodeficiency virus (HIV), hepatitis B or C virus infection
•Patients not recovered to Grade 1 or stabilized from the adverse effects (excluding alopecia) of any prior therapy for their malignancies

Arms & Interventions

ONO-4685 monotherapy

Patients with relapsed or refractory T cell Lymphoma who meet eligibility criteria will be enrolled to receive ONO-4685 monotherapy

Intervention: ONO-4685

Outcomes

Primary Outcomes

Estimate of Maximum Tolerate Dose (MTD)

Time Frame: Up to 3 weeks

MTD will be estimated based on Dose limiting toxicity (DLT) observed during the first 3 weeks of treatment

Incidence, nature, and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs).

Time Frame: Through study completion, an average of 1 year

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.