RECRUITING

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

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Conditions

Relapsed or Refractory T Cell LymphomaONO-4685PD-1CD3Bispecific antibodyPTCLAITLPTCL-NOSnodal PTCL with TFHFTCLCTCLMFSS

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2021-12-10
Study Completion:2026-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05079282

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. Patients with central nervous system (CNS) involvement
  2. 2. Patients with Adult T-cell leukemia/lymphoma (ATLL)
  3. 3. Prior allogeneic stem cell transplant
  4. 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. 5. Prior allogeneic and autologous chimeric antigen receptor (CAR) T-cell therapy
  6. 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. 7. History of severe allergy or hypersensitivity to any monoclonal antibodies, other therapeutic proteins or corticosteroid (e.g., dexamethasone)
  8. 8. History of infection with Mycobacterium tuberculosis within 2 years prior to the first dose of study treatment
  9. 9. Patients with systemic and active infection including human immunodeficiency virus (HIV), hepatitis B or C virus infection
  10. 10. Patients not recovered to Grade 1 or stabilized from the adverse effects (excluding alopecia) of any prior therapy for their malignancies
  11. 11. Women who are pregnant or lactating

Contacts and Locations

Study Contact

Ono Pharma USA, Inc.
CONTACT
clinical_trial@ono-pharma.com

Principal Investigator

Project Leader
STUDY_DIRECTOR
Ono Pharma USA Inc

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
City of Hope
Duarte, California, 91010
United States
University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
New York-Presbyterian/Columbia University Irving Medical Center - Herbert Irving Comprehensive Cancer Center (HICCC)
New York, New York, 10032
United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States
UT Southwestern Medical Center
Dallas, Texas, 75390
United States
MD Anderson
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Ono Pharmaceutical Co. Ltd

  • Project Leader, STUDY_DIRECTOR, Ono Pharma USA Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-10
Study Completion Date2026-06-01

Study Record Updates

Study Start Date2021-12-10
Study Completion Date2026-06-01

Terms related to this study

Keywords Provided by Researchers

  • ONO-4685
  • PD-1
  • CD3
  • Bispecific antibody
  • PTCL
  • AITL
  • PTCL-NOS
  • nodal PTCL with TFH
  • FTCL
  • CTCL
  • MF
  • SS

Additional Relevant MeSH Terms

  • Relapsed or Refractory T Cell Lymphoma