NCT06811272

Outpatient Epcoritamab as 2L in NTE R/R DLBCL

A Phase 2 Study of Outpatient Epcoritamab as Second Line Therapy in Non-Transplant Eligible Relapsed/Refractory Large B-cell Lymphoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to measure the efficacy of the study drug, epcoritamab, in participants with relapsed/refractory large B-cell lymphoma.

Detailed description

This is a phase 2 study of outpatient administration of epcoritamab in non-transplant eligible large B-cell lymphoma that has relapsed after, or is refractory to, 1 prior line of therapy. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The U.S. Food and Drug Administration (FDA) has approved epcoritamab as a treatment option for your disease after at least two prior treatments. The study treatment may continue for up to 24 cycles or until disease progression, unacceptable toxicity, or withdrawal. Participants will be followed for up to 24 months after last dosage of epcoritamab, or until disease progression or withdrawal, whichever occurs first. After 24 months or at time of progression, participants may be followed annually for survival status. It is expected that about 30 people will take part in this research study.

Conditions

• Relapsed Large B-cell Lymphoma
• Refractory Large B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Epcoritamab	Bispecific IgG1 antibody

Timeline

• Start date: 2025-06-05
• Primary completion: 2026-10-01
• Completion: 2028-10-01
• First posted: 2025-02-06
• Last updated: 2026-02-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study