A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL

Ono Pharmaceuticals

Status and phase: Enrolling; Phase 1

Conditions: Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Treatments: Drug: ONO-4685

Study type: Interventional

Funder types: Industry

Identifiers

NCT06547528

ONO-4685-05

Details and patient eligibility

About

A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL

Enrollment: 108 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with histopathologically confirmed diagnosis of one of the following subtypes as defined by the 2017 revision of the WHO classification of lymphoid malignancies:

   Peripheral T-cell lymphoma(PTCL)

   • Angioimmunoblastic T-cell lymphoma(AITL)
   • Peripheral T-cell lymphoma, NOS(PTCL-NOS)
   • Nodal peripheral T-cell lymphoma with TFH phenotype(nodal PTCL with TFH)
   • Follicular T-cell lymphoma(FTCL) Cutaneous T-cell lymphoma(CTCL)
   • Mycosis fungoides(MF)
   • Sezary syndrome Chronic lymphocytic leukemia/small lymphocytic lymphoma(CLL/SLL)

2. Relapsed or refractory patients with tumors for which no established standard therapy is available, or refractory or intolerant to existing standard therapy judged by principal investigator or subinvestigator

3. ECOG PS 0~2

4. Life expectancy of at least 3 months

Exclusion criteria

1. Patients with severe complications.
2. Patients with multiple cancers.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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108 participants in 1 patient group

ONO-4685

Experimental group

Treatment:

Drug: ONO-4685