Study Underway to Evaluate New PD-1/CD3 Antibody in T-cell Lymphoma


A trial is currently recruiting across the US to investigate the safety of a new anti-PD-1/CD3 antibody for the treatment of relapsed or refractory T-cell lymphoma. It aims to enroll 86 patients.

A trial to investigation a new anti-PD-1/CD3 bispecific antibody, ONO-4685, for the treatment of relapsed or refractory T-cell lymphoma, is currently recruiting across the United States, according to a press release by ONO Pharma USA, Inc.

ONO-4695 binds to human PD-1 and CD3. It is being developed simultaneously as a treatment for autoimmune diseases and hematologic malignancies. PD-1 is expressed in activated T and B cells, along with malignant T-cells in some subtypes of T-cell lymphomas. CD3 is also a component protein of T-cell receptors. Non-clinical data suggests that ONO-4695 may be active against T-cell lymphomas.

In interventional, single-group assignment, open label study (NCT05079282) has an estimated enrollment of 86 participants and an estimated study completion date of July 2026. The primary end points of the study are the incidence, nature, and severity of treatment-emergent adverse events (AEs) and treatment-emergent serious AEs, along with estimated maximum tolerated dose. Secondary end points include plasma concentration of ONO-4685 up to 48 weeks, the plasma concentration of anti-drug antibodies up to 48 weeks, and the antitumor activity of ONO-4685 up to 1 year.

During the study, all patients will receive ONO-4685 monotherapy. Treatment will be administered by intravenous infusion and continued until disease progression or unacceptable toxicity.

In order to participate in the study, patients must be at least 18 years of age or older at the time of screening, have a confirmed diagnosis of one of the following:

  • Peripheral T-cell lymphoma (PCTL)
  • Angioimmunoblastic T-cell lymphoma
  • PTCL not otherwise specified
  • Nodal PTCL with T-follicular helper
  • Follicular T-cell lymphoma
  • Cutaneous T-cell lymphoma (CTCL)
  • Mycosis fungoides
  • Sezary syndrome

Additionally, the patient must have received at least 2 prior systemic therapies, at least 1 measurable lesion if the patient has PTCL, patients with CTCL must have assessable disease, an ECOG performance status of 0-2, a life expectancy of at least 3 months, and adequate bone marrow, renal, and hepatic functions.

Patients with central nervous system involvement, adult T-cell leukemia/lymphoma, prior allogeneic stem cell transplant, prior treatment with an anti-PD-1/anti-PD-L1, a history Mycobacterium tuberculosis infection within 2 years of the first study dose, systemic active infection including HIV, and those who are pregnant or lactating are not eligible to participate.

"We are excited to initiate the phase 1 study of ONO-4685, an anti-PD-1/CD3 bispecific antibody with a novel mechanism of action, and hope that ONO-4685 will provide benefit to the patients with relapsed or refractory T-cell lymphoma in the US one day," said Masahiro Katayama, executive vice president, US/EU and head of clinical development, ONO Pharma USA, Inc in a press release.

The study is currently recruiting in Alabama, California, Massachusetts, New York, North Carolina, and Texas.

1.ONO PHARMA USA announces initiation of phase 1 study of ONO-4685, an anti-PD-1/CD3 bispecific antibody, in patients with relapsed or refractory T-cell lymphoma in the U.S. News release. ONO PHARMA USA. October 19, 2021. Accessed October 20,2021.
2.Study of ONO-4685 in patients with relapsed or refractory T Cell lymphoma. Accessed October 20, 2021.
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