Epcoritamab for the Treatment of Relapsed or Refractory Post Transplant Lymphoproliferative Disor… (NCT06672705) | Clinical Trial Compass
RecruitingPhase 1
Epcoritamab for the Treatment of Relapsed or Refractory Post Transplant Lymphoproliferative Disorders
United States26 participantsStarted 2025-06-16
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* Treatment failure of immunosuppression reduction (ISR). NOTE: if ISR was deemed not feasible by treating physician, ISR treatment failure may be waived.
* Treatment failure of rituximab or rituximab plus any concurrent or sequentially administered chemotherapy regimen.
* Measurable disease of \> 1.5 cm in diameter and/or bone marrow involvement.
* Subjects having undergone heart, lung, liver, kidney, pancreas, small intestine transplantation or a combination of the organ transplantations mentioned.
* HIV infection is allowed if viral load is undetectable at time of enrollment, CD4+ count \> 200 cells/uL, and subject remains on anti-viral therapy.
* Resolution of toxicities from prior therapy to a grade that does not contraindicate trial participation in the opinion of the investigator.
* Expected survival greater than 60 days.
* Absolute neutrophil count 1.0 ≥ x 10\^9/L.
* Platelets 50 ≥ x 10\^9/L.
* Creatinine clearance (mL/min) ≥ 30 mL/min - Cockcroft-…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of adverse events
Timeframe: Up to 30 days after the last dose of the study drug
Trial details
NCT IDNCT06672705
SponsorTimothy Voorhees
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2026-12-31
Contact for this trial
The Ohio State University Comprehensive Cancer Center