NCT05079282 Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma
| NCT ID | NCT05079282 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Ono Pharmaceutical Co., Ltd. |
| Condition | Relapsed or Refractory T Cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 217 participants |
| Start Date | 2021-12-10 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 217 participants in total. It began in 2021-12-10 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
Inclusion Criteria 1. Patients aged ≥ 18 years at time of screening 2. Written informed consent by the patient or the patients' legally authorized representative prior to screening 3. Patients with histologically or cytologically confirmed diagnosis of one of the following subtypes of T-cell lymphoma: 1. 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) 2. Cutaneous T-cell lymphoma (CTCL) (stages II-B, III, and IV): Mycosis fungoides (MF) and Sezary syndrome (SS) 4. Patients must have received at least 2 prior systemic therapies 5. Patients with PTCL must have at least 1 measurable lesion (Cheson BD, 2014) 6. Patients with CTCL must have assessable disease by response criteria for CTCL (Olsen EA, 2011) 7. Eastern Cooperative Oncology Group Performance Status (ECOG PS) = 0-2 8. Life expectancy of at least 3 months 9. Adequate bone marrow, renal and hepatic functions Exclusion Criteria: 1. Patients with central nervous system (CNS) involvement 2. Patients with Adult T-cell leukemia/lymphoma (ATLL) 3. Prior allogeneic stem cell transplant 4. 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 5. Prior allogeneic and autologous chimeric antigen receptor (CAR) T-cell therapy 6. 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 7. History of severe allergy or hypersensitivity to any monoclonal antibodies, other therapeutic proteins or corticosteroid (e.g., dexamethasone) 8. History of infection with Mycobacterium tuberculosis within 2 years prior to the first dose of study treatment 9. Patients with systemic and active infection including human immunodeficiency virus (HIV), hepatitis B or C virus infection 10. Patients not recovered to Grade 1 or stabilized from the adverse effects (excluding alopecia) of any prior therapy for their malignancies 11. Women who are pregnant or lactating
Contact & Investigator
Project Leader
STUDY DIRECTOR
Ono Pharmaceutical Co., Ltd.
Frequently Asked Questions
Who can join the NCT05079282 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Relapsed or Refractory T Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05079282 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05079282 currently recruiting?
Yes, NCT05079282 is actively recruiting participants. Contact the research team at clinical_trial@ono-pharma.com for enrollment information.
Where is the NCT05079282 trial being conducted?
This trial is being conducted at Birmingham, United States, Duarte, United States, Orange, United States, Palo Alto, United States and 11 additional locations.
Who is sponsoring the NCT05079282 clinical trial?
NCT05079282 is sponsored by Ono Pharmaceutical Co., Ltd.. The principal investigator is Project Leader at Ono Pharmaceutical Co., Ltd.. The trial plans to enroll 217 participants.