Relapsed or Refractory T Cell Lymphoma
Conditions
Keywords
ONO-4685, PD-1, CD3, Bispecific antibody, PTCL, AITL, PTCL-NOS, nodal PTCL with TFH, FTCL, CTCL, MF, SS
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
Interventions
DRUGONO-4685
ONO-4685 is administered by IV infusion. The administration of ONO-4685 will be continued until disease progression or unacceptable toxicity is observed
Sponsors
Ono Pharmaceutical Co. Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 (Cheson BD, 2014) 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. Prior allogeneic and autologous chimeric antigen receptor (CAR) T-cell therapy 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. History of severe allergy or hypersensitivity to any monoclonal antibodies, other therapeutic proteins or corticosteroid (e.g., dexamethasone) 8. History of infection with Mycobacterium tuberculosis within 2 years prior to the first dose of study treatment 9. Patients with systemic and active infection including human immunodeficiency virus (HIV), hepatitis B or C virus infection 10. Patients not recovered to Grade 1 or stabilized from the adverse effects (excluding alopecia) of any prior therapy for their malignancies 11. Women who are pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence, nature, and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs). | 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) | Up to 3 weeks | MTD will be estimated based on Dose limiting toxicity (DLT) observed during the first 3 weeks of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentration of ONO-4685 | Up to 48 weeks | Plasma concentration will be assessed to evaluate Pharmacokinetics |
| Plasma Concentration of Anti-Drug Antibody (ADA) | Up to 48 weeks | ADA to ONO-4685 will be assessed to evaluate potential immunogenicity. |
| Antitumor Activity of ONO-4685 | Through study completion, an average of 1 year | Antitumor Activity of ONO-4685 will be assessed according to the response criteria for Lymphoma. |
Countries
United States
Contacts
CONTACTNorth America Clinical Trial Support Desk
CONTACTInternational Clinical Trial Support Desk
STUDY_DIRECTORProject Leader
Ono Pharmaceutical Co. Ltd
Outcome results
None listed