Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma
a study on Lymphoma T Cell Lymphoma
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at Orange, California and other locations
- Dates
- study startedcompletion around
Description
Summary
This study will investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ONO-4685 in patients with relapsed or refractory T cell Lymphoma
Official Title
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
Keywords
Relapsed or Refractory T Cell Lymphoma, ONO-4685, PD-1, CD3, Bispecific antibody, PTCL, AITL, PTCL-NOS, nodal PTCL with TFH, FTCL, CTCL, MF, SS, Lymphoma, T-Cell Lymphoma, Lymphoma, T-Cell, Peripheral, ONO-4685 monotherapy
Eligibility
You can join if…
Open to people ages 18 years and up
- 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
You 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 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
- Women who are pregnant or lactating
Locations
- University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center
accepting new patients
Orange California 92868 United States - City of Hope
accepting new patients
Duarte California 91010 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Ono Pharmaceutical Co. Ltd
- ID
- NCT05079282
- Phase
- Phase 1 research study
- Study Type
- Interventional
- Participants
- Expecting 217 study participants
- Last Updated
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