RecruitingPhase 1

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

United States217 participantsStarted 2021-12-10

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

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

What they're measuring

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

Timeframe: Through study completion, an average of 1 year

Estimate of Maximum Tolerate Dose (MTD)

Timeframe: Up to 3 weeks

Trial details

NCT IDNCT05079282

SponsorOno Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-08-31

Contact for this trial

North America Clinical Trial Support Desk

+18665877745(Toll-Free) clinical_trial@ono-pharma.com

View on ClinicalTrials.gov More Relapsed or Refractory T Cell Lymphoma trials