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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05079282
Recruitment Status : Recruiting
First Posted : October 15, 2021
Last Update Posted : December 15, 2021
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Relapsed or Refractory T Cell Lymphoma Drug: ONO-4685 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 10, 2021
Estimated Primary Completion Date : June 1, 2025
Estimated Study Completion Date : June 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: ONO-4685 monotherapy
Patients with relapsed or refractory T cell Lymphoma who meet eligibility criteria will be enrolled to receive ONO-4685 monotherapy
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 :
  1. 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 ]
    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.

  2. Estimate of Maximum Tolerate Dose (MTD) [ Time Frame: Up to 3 weeks ]
    MTD will be estimated based on Dose limiting toxicity (DLT) observed during the first 3 weeks of treatment


Secondary Outcome Measures :
  1. Plasma Concentration of ONO-4685 [ Time Frame: Up to 48 weeks ]
    Plasma concentration will be assessed to evaluate Pharmacokinetics

  2. Plasma Concentration of Anti-Drug Antibody (ADA) [ Time Frame: Up to 48 weeks ]
    ADA to ONO-4685 will be assessed to evaluate potential immunogenicity.

  3. Antitumor Activity of ONO-4685 [ Time Frame: Through study completion, an average of 1 year ]
    Antitumor Activity of ONO-4685 will be assessed according to the response criteria for Lymphoma.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Patients aged ≥ 18 years at time of screening
  2. Written informed consent by the patient or the patients' legally authorized representative prior to screening
  3. Patients with histologically or cytologically confirmed diagnosis of one of the following subtypes of T-cell lymphoma:

    1. 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)
    2. Cutaneous T-cell lymphoma (CTCL) (stages II-B, III, and IV): Mycosis fungoides (MF) and Sezary syndrome (SS)
  4. Patients must have received at least 2 prior systemic therapies.
  5. Patients with PTCL must have at least 1 measurable lesion
  6. Patients with CTCL must have assessable disease by response criteria for CTCL (Olsen EA, 2011)
  7. Eastern Cooperative Oncology Group Performance Status (ECOG PS) = 0-2
  8. Life expectancy of at least 3 months
  9. Adequate bone marrow, renal and hepatic functions

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. 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
  6. History of severe allergy or hypersensitivity to any monoclonal antibodies, other therapeutic proteins or corticosteroid (e.g., dexamethasone)
  7. History of infection with Mycobacterium tuberculosis within 2 years prior to the first dose of study treatment
  8. Patients with systemic and active infection including human immunodeficiency virus (HIV), hepatitis B or C virus infection
  9. Patients not recovered to Grade 1 or stabilized from the adverse effects (excluding alopecia) of any prior therapy for their malignancies
  10. Women who are pregnant or lactating

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05079282


Contacts
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Contact: Ono Pharmaceutical Co. Ltd Medical Information Center clinical_trial@ono.co.jp

Locations
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United States, Alabama
University of Alabama at Birmingham Not yet recruiting
Birmingham, Alabama, United States, 35294
United States, California
University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center Not yet recruiting
Orange, California, United States, 92868
United States, Massachusetts
Dana Farber Cancer Institute Not yet recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos Cancer Institute Not yet recruiting
Detroit, Michigan, United States, 48201
United States, New York
Roswell Park Cancer Institute Not yet recruiting
Buffalo, New York, United States, 14263
Memorial Sloan-Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10065
United States, North Carolina
Novant Health Presbyterian Medical Center Recruiting
Charlotte, North Carolina, United States, 28204
United States, Oregon
Oregon Health & Science University Not yet recruiting
Portland, Oregon, United States, 97239
United States, Texas
MD Anderson Not yet recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Ryota Shiibashi Ono Pharma USA Inc
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Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT05079282    
Other Study ID Numbers: ONO-4685-03
First Posted: October 15, 2021    Key Record Dates
Last Update Posted: December 15, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
URL: https://www.ono.co.jp/eng/rd/policy.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ono Pharmaceutical Co. Ltd:
ONO-4685
PD-1
CD3
Bispecific antibody
PTCL
AITL
PTCL-NOS
nodal PTCL with TFH
FTCL
CTCL
MF
SS
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin