Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma
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ClinicalTrials.gov Identifier: NCT05079282 |
Recruitment Status :
Recruiting
First Posted : October 15, 2021
Last Update Posted : May 3, 2024
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Condition or disease | Intervention/treatment | Phase |
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Relapsed or Refractory T Cell Lymphoma | Drug: ONO-4685 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 217 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 |
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
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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 |
- 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.
- 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
- Plasma Concentration of ONO-4685 [ Time Frame: Up to 48 weeks ]Plasma concentration will be assessed to evaluate Pharmacokinetics
- Plasma Concentration of Anti-Drug Antibody (ADA) [ Time Frame: Up to 48 weeks ]ADA to ONO-4685 will be assessed to evaluate potential immunogenicity.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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
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
Contact: Ono Pharma USA, Inc. | clinical_trial@ono-pharma.com |
United States, Alabama | |
University of Alabama at Birmingham | Recruiting |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center | Recruiting |
Orange, California, United States, 92868 | |
United States, Massachusetts | |
Dana Farber Cancer Institute | Withdrawn |
Boston, Massachusetts, United States, 02215 | |
United States, Michigan | |
Karmanos Cancer Institute | Recruiting |
Detroit, Michigan, United States, 48201 | |
United States, New York | |
Roswell Park Cancer Institute | Not yet recruiting |
Buffalo, New York, United States, 14263 | |
New York-Presbyterian/Columbia University Irving Medical Center - Herbert Irving Comprehensive Cancer Center (HICCC) | Recruiting |
New York, New York, United States, 10032 | |
Memorial Sloan-Kettering Cancer Center | 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 | Recruiting |
Portland, Oregon, United States, 97239 | |
United States, Texas | |
UT Southwestern Medical Center | Recruiting |
Dallas, Texas, United States, 75390 | |
MD Anderson | Recruiting |
Houston, Texas, United States, 77030 |
Study Director: | Project Leader | Ono Pharma USA Inc |
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: | May 3, 2024 |
Last Verified: | May 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
ONO-4685 PD-1 CD3 Bispecific antibody PTCL AITL |
PTCL-NOS nodal PTCL with TFH FTCL CTCL MF SS |
Lymphoma Lymphoma, T-Cell Lymphoma, T-Cell, Peripheral Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |