Epcoritamab for Relapsed or Refractory Post-Transplant Lymphoproliferative Disorders
This study is testing a drug called epcoritamab for people with post-transplant lymphoproliferative disorder (PTLD) that has come back (relapsed) or hasn't responded to other treatments (refractory). Epcoritamab is a special type of antibody that helps your immune system find and fight cancer cells. It works by targeting two proteins: CD3 on your immune cells and CD20 on some lymphoma cells. The main goal is to see how safe epcoritamab is. Researchers will also look at how well it shrinks tumors and how long people live without their disease getting worse. You may be able to join if you are 18 or older and meet certain health criteria. The study plans to enroll 26 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 26 participants, but the phase is not specified.
- What's involved
- You would undergo procedures like biopsies, blood sample collection, and PET/CT scans. You would also receive epcoritamab given as an injection under the skin.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for up to 30 days after your last dose of epcoritamab.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06672705
Epcoritamab for the Treatment of Relapsed or Refractory Post Transplant Lymphoproliferative Disorders
Recruiting
PHASE1Ages 18+InterventionalTreatmentTimothy VoorheesInvestigator-initiated
~26 participants
Updated 2025-08-19 on ClinicalTrials.gov
What's tested:BiopsyBiospecimen CollectionComputed TomographyEpcoritamabPositron Emission Tomography
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over Up to 30 days after the last dose of the study drug
Conditions
NCT06672705
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Ohio State University Comprehensive Cancer Center
Columbus, Ohiostudy coordinator listed
Recruiting
Washington University
St Louis, Missouristudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Timothy J Voorhees, MD · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Want this trial checked against your situation?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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-Gault Equation.
Note: Hematology and other lab parameters that are ≤ grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy.
Bilirubin ≤ 3.0 x upper limit of normal (ULN). Subjects with Gilbert's syndrome may be enrolled despite a total bilirubin level \> 3.0 mg/dL if their conjugated bilirubin is ≤ 3.0 × ULN).
Note: Hematology and other lab parameters that are ≤ grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy.
Aspartate aminotransferase (AST) ≤ 3.0 x ULN.
Note: Hematology and other lab parameters that are ≤ grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy.
Alanine aminotransferase (ALT) ≤ 3.0 x ULN.
Note: Hematology and other lab parameters that are ≤ grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy.
Females of childbearing potential must have a negative serum pregnancy test within 3 days prior to registration. NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months. Documentation of postmenopausal status must be provided.
Females of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 12 months after treatment the last dose of epcoritamab. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device.
Male subjects with female partners must have had a prior vasectomy or agree to use an adequate method of contraception (i.e., double barrier method: condom plus spermicidal agent) starting with the first dose of study therapy through 12 months after the last dose of epcoritamab.
Subjects with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the experimental regimen are eligible for the trial.
Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
Exclusion
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.
Seizure disorder requiring therapy (such as steroids or anti-epileptics).
Uncontrolled concomitant illness including, but not limited to, symptomatic congestive heart failure (New York Heart Association (NYHA) Class III or IV), unstable angina pectoris, myocardial infarction within 1 month prior to enrollment, uncontrolled cardiac arrhythmias, uncontrolled seizures, or severe non-compensated hypertension (systolic blood pressure \> 180mmHg or diastolic blood pressure \> 120mmHg).
History of progressive multifocal leukoencephalopathy.
Active Hepatitis B infection or Hepatitis C infection with positive viral polymerase chain reaction (PCR) from the blood. Subjects with active Hepatitis B infection and undetectable viral PCR from the blood will be allowed with concurrent use of entecavir suppression. Subjects with history of Hepatitis C infection (undetectable viral PCR) are allowed.
Electrocardiogram (ECG) abnormality at screening has to be documented by the investigator as not medically relevant.
Any condition, including the presence of laboratory values which is deemed by the clinician to place the subject at an unacceptable risk or confounds the ability to interpret the data from this study.
Live virus vaccines must not be administered within 28 days of the start of study treatment.
Any investigational treatments must have been completed at least 4 weeks or 5 half-lives, whichever is shorter, prior to the start of study treatment. Investigational antibody therapies are not included in this requirement.
What this trial measures
- Incidence of adverse eventsUp to 30 days after the last dose of the study drug
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.