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New treatment option for Relapsed or Refractory T Cell Lymphoma
Official title Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma
ClinicalTrials.gov ID: NCT05079282
What this study is testing
What is ONO-4685?
ONO-4685 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed or refractory t cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ONO-4685 in patients with relapsed or refractory T cell Lymphoma
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Cutaneous T-cell lymphoma (CTCL) (stages II-B, III, and IV): Mycosis fungoides (MF) and Sezary syndrome (SS)
You likely can't join if
- 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...
- 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...
See the full eligibility 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
- Adequate bone marrow, renal and hepatic functions
- 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...
- 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
- Women who are pregnant or lactating
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Duarte, California, United States
- Orange, California, United States
- Palo Alto, California, United States
- New Haven, Connecticut, United States
- Atlanta, Georgia, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- St Louis, Missouri, United States
- Hackensack, New Jersey, United States
- Buffalo, New York, United States
- New York, New York, United States
- Charlotte, North Carolina, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Duarte, California, United States; Orange, California, United States; Palo Alto, California, United States; New Haven, Connecticut, United States; Atlanta, Georgia, United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.