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

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Primary Objectives:

Dose escalation phase

To assess the safety and tolerability of ONO-4685 in patients with relapsed or refractory T-cell lymphoma

Expansion phase

To assess the safety of ONO-4685 in patients with relapsed or refractory T-cell lymphoma

Secondary Objectives:

Dose escalation phase and Expansion phase

To assess preliminary efficacy, PK, and immunogenicity of ONO-4685 in patients with relapsed or refractory T-cell lymphoma
To assess optimal dose of ONO-4685 for further clinical evaluations

Exploratory objectives:

Dose escalation phase and Expansion phase

To assess exploratory biomarkers in patients with relapsed or refractory T-cell lymphoma including:
- PD-1, CD3, and other protein expression on tumor cells
- Serum cytokines including IL-2, IL-6, IL-10, IFN-γ, and TNF-α
- Lymphocyte subset analysis
- TCR repertoire analysis

Eligibility

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

Locations

4100 John R
Detroit, MI 48201
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Phone: 800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices