Health Trials

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

ConditionsDiffuse Large B-Cell Lymphoma Post-Transplant Lymphoproliferative DisorderEBV-Related Post-Transplant Lymphoproliferative DisorderRecurrent Monomorphic Post-Transplant Lymphoproliferative DisorderRecurrent Polymorphic Post-Transplant Lymphoproliferative DisorderRefractory Monomorphic Post-Transplant Lymphoproliferative DisorderRefractory Polymorphic Post-Transplant Lymphoproliferative Disorder
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTimothy Voorhees

About this trial

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.

Eligibility criteria

Qualifiers

Written informed consent obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information to the sponsor, sites, and relevant study organizations.

Age ≥ 18 years at the time of consent.

Karnofsky scale ≥ 50% or Eastern Cooperative Oncology Group (ECOG) ≤ 2.

Histological evidence of B-cell PTLD (any histologic subtype) following solid organ transplantation; expresses CD20; with or without EBV association.

Disqualifiers

Uncontrolled active (symptomatic) infection. Patients requiring systemic therapy are eligible if the infection is deemed controlled by the investigator.

Post-transplant lymphoproliferative disorder following stem cell transplantation for hematologic malignancies or nonmalignant conditions.

Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study and lactating females must agree to not breastfeed while taking study drug).

Subjects with central nervous system (CNS) involvement by PTLD.

Trial design

Treatments tested in this trial

  • Biopsy
  • Biospecimen Collection
  • Computed Tomography
  • Epcoritamab
  • Positron Emission Tomography

Treatment groups

26 Participants
are divided into 1 treatment group

Sponsors and collaborators

Timothy Voorhees

Lead sponsor

Ohio State University Comprehensive Cancer Center

Sponsor institution

AbbVie

Collaborator

Genmab

Collaborator

Source ClinicalTrials.gov