NCT07197307

Combining Loncastuximab Tesirine and Epcoritamab in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Universität Münster · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II study designed to evaluate the toxicity and efficacy of the combination of loncastuximab tesirine and epcoritamab in patients with relapsed/refractory aggressive B-cell lymphoma. Chimeric antigen receptor (CAR)-T cell naive patients who have failed first-line therapy and patients who have received CAR-T cells as second-line therapy and experienced CAR-T failure will be eligible for inclusion.

Detailed description

A total of 120 patients will be included. 60 days after 20 patients have started the therapy, a safety analysis will be performed to identify early and unexpected side effects of the combination therapy. An interim analysis will be conducted 6 months after recruitment of the 50th patient to check the effectiveness of the therapy.

Conditions

• Aggressive Diffuse Large B-cell Lymphoma
• High-grade B-cell Lymphoma (HGBL)
• Follicular Lymphoma (FL) Grade 3B

Interventions

Type	Name	Description
DRUG	Loncastuximab Tesirine and Epcoritamab	Combination therapy of loncastuximab tesirine and epcoritamab

Timeline

• Start date: 2025-10-15
• Primary completion: 2030-01-15
• Completion: 2030-01-15
• First posted: 2025-09-29
• Last updated: 2025-09-29

Locations

1 site across 1 country: Germany