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Recruiting NCT05079282

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

Phase I Interventional Relapsed or Refractory T Cell Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ONO-4685.
Who it may be relevant to
Registry conditions: Relapsed or Refractory T Cell Lymphoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Interventions

  • Drug ONO-4685
    ONO-4685 is administered by IV infusion. The administration of ONO-4685 will be continued until disease progression or unacceptable toxicity is observed

Primary outcome measures

  • 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]
  • Estimate of Maximum Tolerate Dose (MTD) [Time frame: Up to 3 weeks]
Secondary outcome measures (3)
  • Plasma Concentration of ONO-4685 [Time frame: Up to 48 weeks]
  • Plasma Concentration of Anti-Drug Antibody (ADA) [Time frame: Up to 48 weeks]
  • Antitumor Activity of ONO-4685 [Time frame: Through study completion, an average of 1 year]

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
  • Adequate bone marrow, renal and hepatic functions

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
  • Women who are pregnant or lactating

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 20 centers
  • University of Alabama at Birmingham — Birmingham
  • City of Hope — Duarte
  • University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center — Orange
  • Stanford Cancer Institute — Palo Alto
  • Yale Cancer Center — New Haven
  • Winship Cancer Institute of Emory University — Atlanta
  • Dana Farber Cancer Institute — Boston
  • Karmanos Cancer Institute — Detroit
  • … and 12 more centers

Identifiers

NCT: NCT05079282 · ONO-4685-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗