Back to Results


Title M23-362, A Phase 2, Open-Label Trial to Evaluate Safety of Epcoritamab Monotherapy in Subjects with Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma Grade 1-3a when Administered in the Outpatient Setting
Therapeutic Area Lymphomas (adult)
Principal Investigator Yun Cho, MD
Min Age 18 Years
Gender Any
Contact Abha Kulkarni
More Information


The purpose of this study is to assess the safety of epcoritamab in adult participants in relapsed or refractory (R/R) diffuse large b-cell lymphoma (DLBCL) or R/R follicular lymphoma (FL). Epcoritamab is an investigational drug being developed for the treatment of R/R DLBCL and R/R FL. Study doctors will assess participants in a monotherapy treatment arm of epcoritamab.

Study Details

Inclusion Criteria

1. Diagnosis of Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) or R/R Follicular Lymphoma (FL) grade 1, 2, or 3a, with documented CD20+ mature B-cell neoplasm

2. Must have 1 or more measurable disease sites: Fluorodeoxyglucose (FDG)-avid lymphomas or FDG-nonavid lymphomas.

3. Must have Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.

Exclusion Criteria

1. Central nervous system (CNS) involvement.

Study Requirements

Participants will receive escalating doses of epcoritamab, until full dose is achieved. Approximately 80 adult participants with R/R DLBCL and R/R FL will be enrolled in the study in approximately 40 in the United States of America. Participants will receive escalating doses of subcutaneous epcoritamab, until full dose is achieved, in 28-day cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.