Actively Recruiting
Epcoritamab for the Treatment of Relapsed or Refractory Post Transplant Lymphoproliferative Disorders
Led by Timothy Voorhees · Updated on 2025-08-19
26
Participants Needed
2
Research Sites
80 weeks
Total Duration
On this page
Sponsors
T
Timothy Voorhees
Lead Sponsor
A
AbbVie
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Epcoritamab for the Treatment of Relapsed or Refractory Post Transplant Lymphoproliferative Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent and HIPAA authorization
- Age 18 years or older at consent
- Karnofsky performance status 50% or greater or ECOG score 0 to 2
- Histological confirmation of B-cell PTLD with CD20 expression after solid organ transplant
- Failure of immunosuppression reduction treatment or waiver if not feasible
- Failure of rituximab or rituximab plus chemotherapy treatment
- Measurable disease larger than 1.5 cm or bone marrow involvement
- Received heart, lung, liver, kidney, pancreas, small intestine, or combined organ transplantation
- HIV infection allowed if viral load undetectable, CD4+ count above 200 cells/uL, and on antiviral therapy
- Resolved prior treatment toxicities to a safe level
- Expected survival longer than 60 days
- Absolute neutrophil count at least 1.0 x 10^9/L
- Platelet count at least 50 x 10^9/L
- Creatinine clearance at least 30 mL/min by Cockcroft-Gault equation
- Bilirubin less than or equal to 3 times upper limit of normal (ULN), exceptions for Gilbert's syndrome
- AST and ALT less than or equal to 3 times ULN
- Females of childbearing potential with negative pregnancy test within 3 days before enrollment
- Females of childbearing potential willing to use two forms of contraception or abstain from heterosexual activity from consent through 12 months after last dose
- Male subjects with female partners must have prior vasectomy or use double barrier contraception from first dose through 12 months after last dose
- Prior or concurrent malignancy allowed if it does not interfere with study assessment
- Willing and able to comply with study procedures as judged by investigator
You will not qualify if you...
- Uncontrolled active symptomatic infection
- PTLD following stem cell transplant for blood cancers or nonmalignant conditions
- Pregnant or breastfeeding women
- PTLD involving the central nervous system
- Seizure disorder requiring treatment
- Uncontrolled serious illnesses such as severe heart failure, unstable angina, recent heart attack, uncontrolled arrhythmias, uncontrolled seizures, or severe high blood pressure
- History of progressive multifocal leukoencephalopathy
- Active Hepatitis B or Hepatitis C infection with positive viral PCR, except controlled Hepatitis B with entecavir
- ECG abnormalities deemed medically relevant by investigator
- Any condition or lab value placing subject at unacceptable risk or confounding data interpretation
- Live virus vaccines within 28 days before study treatment
- Investigational treatments completed less than 4 weeks or 5 half-lives before study treatment, except investigational antibody therapies
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
2
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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