A Phase I/II Multicentric Study to Determine the Safety and Efficacy of a Combination of Anti-CD3 & Anti-CD7 Ricin A Immunotoxins for the Treatment of Steroid-Resistant Acute Graft-Versus-Host Disease
"The experimental design is a non-controlled multicentric fixed-dose Phase I/II study. A
total of 12 evaluable patients will be enrolled in 4 transplant centers throughout the
Netherlands, in a 9 to 12 months period. The treatment consists of a standard dose of 4
infusions IT-combination (4 mg/m2), given 48-hours apart over a 4-hour period.
The intended follow-up period is 12 months. The patient will also be asked to participate
in additional research aiming at determining the presence and evolution of biomarkers
suggestive for the extent to which the IT-combination 'resets the T-cell compartment,
induces clinical tolerance, and/or enhances the risk of over-immunosuppression."
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The acute GVHD response rate on study Day 29
Anton V Schattenberg,, MD, PhD,
Department of Hematology Radboud University Nijmegen (RUN) Medical Centre
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)