Epcoritamab for the Treatment of Relapsed or Refractory Post Transplant Lymphoproliferative Disorders

Conditions

• Diffuse Large B-Cell Lymphoma Post-Transplant Lymphoproliferative Disorder
• EBV-Related Post-Transplant Lymphoproliferative Disorder
• Recurrent Monomorphic Post-Transplant Lymphoproliferative Disorder
• Recurrent Polymorphic Post-Transplant Lymphoproliferative Disorder
• Refractory Monomorphic Post-Transplant Lymphoproliferative Disorder
• Refractory Polymorphic Post-Transplant Lymphoproliferative Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biopsy — PROCEDURE
  Undergo biopsy
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Computed Tomography — PROCEDURE
  Undergo PET/CT
• Epcoritamab — BIOLOGICAL
  Given SC
• Positron Emission Tomography — PROCEDURE
  Undergo PET/CT

Study Details

This phase Ib trial tests the safety and effectiveness of epcoritamab in treating patients with post-transplant lymphoproliferative disorder (PTLD) that has come back after a period of improvement (relapsed) or has not responded to previous treatment (refractory). Epcoritamab, a bispecific antibody, binds to a protein called CD3, which is found on T cells (a type of white blood cell). It also binds to a protein called CD20, which is found on B cells (another type of white blood cell) and some lymphoma cells. This may help the immune system kill cancer cells. Giving epcoritamab may be safe and effective in treating patients with relapsed or refractory B-cell PTLD.

Key Dates

Start date

Jun 16, 2025

Status verified

Aug 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

26 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (epcoritamab)
  Patients receive epcoritamab SC on days 1, 8, 15, and 22 of cycles 1 and 2, days 1 and 15 of cycles 4-9, and day 1 of each subsequent cycle. Cycles repeat every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients with CR may continue to receive epcoritamab if disease progression occurs within 6 months. Patients with PR or SD continue to receive epcoritamab in the absence of disease progression or unacceptable toxicity. Patients also undergo PET/CT and blood sample collection throughout the study and may undergo biopsy during screening.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 30 days after the last dose of the study drug ]

Central Contacts

• The Ohio State University Comprehensive Cancer Center
  800-293-5066
  [email protected]

Locations (2)

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