Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Biopsy

    Procedure/Surgery

    Undergo biopsy

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Computed Tomography

    Procedure/Surgery

    Undergo PET/CT

  • Epcoritamab

    Biological/Vaccine

    Given SC

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/CT

Treatment groups

26 Participants
are divided into 1 treatment group
Group A: Treatment (epcoritamab)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Incidence of adverse events

Will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) grading for cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). The dose limiting toxicity period will be the first 28 days after the first dose of epcoritamab.

Time frame
Up to 30 days after the last dose of the study drug

Secondary outcomes

1

Objective response rate (ORR)

Will be defined as the number of patients who achieve complete response (CR) + partial response (PR) divided by the number of evaluable patients, and presented with the 95% binomial confidence interval. Will be assessed using Lugano (with LYRIC modification) response criteria.

Time frame
Up to completion of cycle 3 (1 cycle = 28 days)
2

Clinical benefit rate (CBR)

Will be defined as clinical response (CR + PR + stable disease) after 6 cycles of epcoritamab using Lugano (with LYRIC modification) response criteria. CBR rate will be estimated and 95% confidence interval computed.

Time frame
Up to 6 cycles (1 cycle = 28 days)
3

Best Overall Response Rate (ORR)

Will be defined as the number of patients who achieve best ORR (CR + PR) at any time after treatment with epcoritamab. Will be estimated with the 95% binomial confidence interval. Will be assessed using Lugano (with LYRIC modification) response criteria.

Time frame
Up to 3 years
4

Progression free survival

Will be estimated using the Kaplan-Meier method. Will be assessed using the LYRIC response criteria.

Time frame
From the date of treatment initiation to date of progression or death, whichever occurs first, assessed up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Timothy Voorhees

Lead sponsor

Ohio State University Comprehensive Cancer Center

Sponsor institution

AbbVie

Collaborator

Genmab

Collaborator

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
Apply now