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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Ono Pharmaceutical Co., Ltd.
Study ID
NCT05079282
Phase
PHASE1
Status
Recruiting

Conditions

  • Relapsed or Refractory T Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Dec 10, 2021
Status verified
Feb 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
217 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ONO-4685 monotherapy
    Patients with relapsed or refractory T cell Lymphoma who meet eligibility criteria will be enrolled to receive ONO-4685 monotherapy

Primary Outcome Measure

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 ]

Central Contacts

Locations (20)

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