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Protocol Summary


Protocol No.
PSCI-22-042
Prinicipal Investigator
Naik, Seema
Phase
Phase II
Age Group
Adult
Scope
National
Secondary Protocol No.
M23-362
Title
A Phase 2, Open-Label Trial to Evaluate Safety of Epcoritamab Monotherapy in Subjects with Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma (Previously Grade 1-3a) when Administered in the Outpatient Setting
Objective
Primary Objective: The primary objective of this Phase 2 study is to evaluate the safety of epcoritamab monotherapy without mandatory hospitalization for the first full dose of epcoritamab in subjects with R/R DLBCL or R/R FL Grade 1-3a who have received at least 2 prior lines of systemic anti-lymphoma therapies including at least 1 anti-CD20 monoclonal
antibody-containing therapy.

Secondary Objective: The secondary objective of this Phase 2 study is preliminary assessment for overall safety and efficacy of monotherapy of epcoritamab in outpatient setting.
Applicable Disease Sites
Non-Hodgkin's Lymphoma
Status
Open
Participating Institutions
Hershey Medical Center