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

Primary Purpose

Relapsed or Refractory T Cell Lymphoma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ONO-4685
Sponsored by
Ono Pharmaceutical Co. Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed or Refractory T Cell Lymphoma focused on measuring ONO-4685, PD-1, CD3, Bispecific antibody, PTCL, AITL, PTCL-NOS, nodal PTCL with TFH, FTCL, CTCL, MF, SS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • University of California Irvine Medical Center - Chao Family Comprehensive Cancer CenterRecruiting
  • Dana Farber Cancer Institute
  • Karmanos Cancer InstituteRecruiting
  • Roswell Park Cancer Institute
  • New York-Presbyterian/Columbia University Irving Medical Center - Herbert Irving Comprehensive Cancer Center (HICCC)Recruiting
  • Memorial Sloan-Kettering Cancer CenterRecruiting
  • Novant Health Presbyterian Medical CenterRecruiting
  • Oregon Health & Science UniversityRecruiting
  • UT Southwestern Medical CenterRecruiting
  • MD AndersonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ONO-4685 monotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

Incidence, nature, and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs).
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.
Estimate of Maximum Tolerate Dose (MTD)
MTD will be estimated based on Dose limiting toxicity (DLT) observed during the first 3 weeks of treatment

Secondary Outcome Measures

Plasma Concentration of ONO-4685
Plasma concentration will be assessed to evaluate Pharmacokinetics
Plasma Concentration of Anti-Drug Antibody (ADA)
ADA to ONO-4685 will be assessed to evaluate potential immunogenicity.
Antitumor Activity of ONO-4685
Antitumor Activity of ONO-4685 will be assessed according to the response criteria for Lymphoma.

Full Information

First Posted
September 30, 2021
Last Updated
August 16, 2023
Sponsor
Ono Pharmaceutical Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05079282
Brief Title
Study 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 10, 2021 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharmaceutical Co. Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory T Cell Lymphoma
Keywords
ONO-4685, PD-1, CD3, Bispecific antibody, PTCL, AITL, PTCL-NOS, nodal PTCL with TFH, FTCL, CTCL, MF, SS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
217 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ONO-4685 monotherapy
Arm Type
Experimental
Arm Description
Patients with relapsed or refractory T cell Lymphoma who meet eligibility criteria will be enrolled to receive ONO-4685 monotherapy
Intervention Type
Drug
Intervention Name(s)
ONO-4685
Intervention Description
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 Measure Information:
Title
Incidence, nature, and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs).
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Estimate of Maximum Tolerate Dose (MTD)
Description
MTD will be estimated based on Dose limiting toxicity (DLT) observed during the first 3 weeks of treatment
Time Frame
Up to 3 weeks
Secondary Outcome Measure Information:
Title
Plasma Concentration of ONO-4685
Description
Plasma concentration will be assessed to evaluate Pharmacokinetics
Time Frame
Up to 48 weeks
Title
Plasma Concentration of Anti-Drug Antibody (ADA)
Description
ADA to ONO-4685 will be assessed to evaluate potential immunogenicity.
Time Frame
Up to 48 weeks
Title
Antitumor Activity of ONO-4685
Description
Antitumor Activity of ONO-4685 will be assessed according to the response criteria for Lymphoma.
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ono Pharma USA, Inc.
Email
clinical_trial@ono-pharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Project Leader
Organizational Affiliation
Ono Pharma USA Inc
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Withdrawn
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
New York-Presbyterian/Columbia University Irving Medical Center - Herbert Irving Comprehensive Cancer Center (HICCC)
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
Novant Health Presbyterian Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Name
MD Anderson
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing URL
https://www.ono.co.jp/eng/rd/policy.html

Learn more about this trial

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

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