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

Sponsor
Universität Münster
Study ID
NCT07197307
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Loncastuximab Tesirine and Epcoritamab — DRUG
    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).

Study Details

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.

Key Dates

First listed
Sep 29, 2025
Start date
Oct 31, 2025
Status verified
Jul 2026
Primary completion
Apr 30, 2030
Completion
Apr 30, 2030

Study Design

Enrollment
120 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Loncastuximab Tesirine and Epcoritamab
    Combination of loncastuximab tesirine and epcoritamab in patients with relapsed/refractory aggressive B-cell lymphoma (DLBCL, HGBL or FL grade 3B)

Primary Outcome Measure

Best overall response rate (BORR) [ Time Frame: 12 months after the start of study therapy ]

Central Contacts