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

NCT06672705 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: OSU-23408NCI-2024-08887
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

Brief 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.

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

Outcome Measures

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.

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

Secondary Outcomes (6)

• Objective response rate (ORR)

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

• Clinical benefit rate (CBR)

  Up to 6 cycles (1 cycle = 28 days)

• Best Overall Response Rate (ORR)

  Up to 3 years

• Progression free survival

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

• Duration of complete response

  From treatment response to date of progression or death, whichever occurs first, assessed up to 3 years

Study Arms (1)

Treatment (epcoritamab)

EXPERIMENTAL

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.

Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Biological: Epcoritamab; Procedure: Positron Emission Tomography

Interventions

Biopsy PROCEDURE

Undergo biopsy

Also known as: BIOPSY_TYPE, Bx

Treatment (epcoritamab)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (epcoritamab)

Computed Tomography PROCEDURE

Undergo PET/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Treatment (epcoritamab)

Epcoritamab BIOLOGICAL

Given SC

Also known as: Anti-CD20/CD3 Bispecific Antibody GEN3013, DuoBody-CD3xCD20, Epcoritamab-bysp, Epkinly, GEN 3013, GEN-3013, GEN3013, Tepkinly

Treatment (epcoritamab)

Positron Emission Tomography PROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT

Treatment (epcoritamab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Timothy Voorhees: lead
• AbbVie: collaborator
• Genmab: collaborator

Study Sites (2)

Washington University

St Louis, Missouri, 63110, United States

RECRUITING

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

• The Jamesline

MeSH Terms

Interventions

Biopsy; Specimen Handling; Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Timothy J Voorhees, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 4, 2024
• Study Start: June 16, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

US (2)