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

Phase 1

Recruiting

• Conditions: Relapsed or Refractory T Cell Lymphoma
• Interventions: Drug: ONO-4685

• Registration Number: NCT05079282
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-30
• Study First Submitted QC: 2021-10-14
• Study First Posted: 2021-10-15
• Study Start: 2021-12-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-19
• Primary Completion: 2025-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 217

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ONO-4685 monotherapy	ONO-4685	Patients with relapsed or refractory T cell Lymphoma who meet eligibility criteria will be enrolled to receive ONO-4685 monotherapy

Primary Outcome Measures

Name	Time	Method
Estimate of Maximum Tolerate Dose (MTD)	Up to 3 weeks	MTD will be estimated based on Dose limiting toxicity (DLT) observed during the first 3 weeks of treatment
Incidence, nature, and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs).	Through study completion, an average of 1 year	Adverse events with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 used as a guide for the grading of severity.

Secondary Outcome Measures

Name	Time	Method
Plasma Concentration of ONO-4685	Up to 48 weeks	Plasma concentration will be assessed to evaluate Pharmacokinetics
Plasma Concentration of Anti-Drug Antibody (ADA)	Up to 48 weeks	ADA to ONO-4685 will be assessed to evaluate potential immunogenicity.
Antitumor Activity of ONO-4685	Through study completion, an average of 1 year	Antitumor Activity of ONO-4685 will be assessed according to the response criteria for Lymphoma.

Trial Locations

Locations (15)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

City of Hope; 🇺🇸 Duarte, California, United States

University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center; 🇺🇸 Orange, California, United States

Stanford Cancer Institute; 🇺🇸 Palo Alto, California, United States

Yale Cancer Center; 🇺🇸 New Haven, Connecticut, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States

New York-Presbyterian/Columbia University Irving Medical Center - Herbert Irving Comprehensive Cancer Center (HICCC); 🇺🇸 New York, New York, United States

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States

Novant Health Presbyterian Medical Center; 🇺🇸 Charlotte, North Carolina, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

MD Anderson; 🇺🇸 Houston, Texas, United States