Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
estimated completion

Description

Summary

This study will investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy 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

Keywords

Relapsed or Refractory T Cell Lymphoma ONO-4685 PD-1 CD3 Bispecific antibody PTCL AITL PTCL-NOS nodal PTCL with TFH FTCL CTCL MF SS Lymphoma Lymphoma, T-Cell ONO-4685 monotherapy

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

  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

Locations

  • University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center
    Orange California 92868 United States
  • MD Anderson
    Houston Texas 77030 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Ono Pharmaceutical Co. Ltd
ID
NCT05079282
Phase
Phase 1
Study Type
Interventional
Last Updated