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

NCT07197307 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-07-30

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Loncastuximab Tesirine and Epcoritamab

Loncastuximab tesirine: Loncastuximab tesirine 150 µg/kg iv for 2 cycles followed by 75 µg/kg iv on day 1 of each 21-day cycle in responding patients for 4 cycles subsequently (max. 6 cycles). Epcoritamab: Step-up dosing for epcoritamab sc will be performed, consisting of a 0.16 mg sc priming dose on day 1 of cycle 1 (day 8 of cycle 1 for loncastuximab tesirine), followed by a 0.8 mg sc dose on day 8, and full dosing with 48 mg sc on day 15. Starting from day 15, epcoritamab will be administered weekly during cycle 2-3, then once every 2 weeks during cycle 4-9, and once every 4 weeks from cycle 10 until cycle 13 (max. 13 cycles).

Sponsors & Collaborators

  • AbbVie

    collaborator INDUSTRY

  • Sobi, Inc.

    collaborator INDUSTRY

  • Universität Münster

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2030-04-30
Completion
2030-04-30

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07197307 on ClinicalTrials.gov