About this trial
The purpose of phase I of this clinical trial is to learn the recommended dose of the drugs loncastuximab tesirine and rituximab in participants with post-transplant lymphoproliferative disorders (PTLD).
The purpose of phase II of this clinical trial is to learn if the drugs loncastuximab tesirine and rituximab are effective in participants with post-transplant lymphoproliferative disorders (PTLD).
Eligibility criteria
Qualifiers
Subject aged ≥ 18 years.
Histologically confirmed B-cell PTLD (monomorphic and polymorphic) following solid organ transplantation; with or without EBV association.
Measurable disease as defined by the 2014 Lugano Classification as assessed by positron-emission tomography (PET)- computed tomography (CT) or by CT or magnetic resonance imaging (MRI) if the tumor is not fluorodeoxyglucose (FDG)-avid on screening
ECOG Performance Status ≤ 2.
Disqualifiers
PTLD following liquid transplantation
CNS involvement
Prior treatment for PTLD with the exception of radiation, antivirals, steroids and reduced immunosuppression
Human immunodeficiency virus (HIV) infection
Trial design
Treatments tested in this trial
- Loncastuximab tesirine
- Rituximab or rituximab biosimilar
Treatment groups
6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
University of Utah
Lead sponsor
ADC Therapeutics S.A.
Collaborator