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Christoph Groth, University Hospital of Muenster, Muenster, Germany, and colleagues conducted a phase I/II trial to evaluate the safety and efficacy of an immunotoxin-combination, a mixture of anti-CD3 and anti-CD7 antibodies separately conjugated to recombinant ricin A (CD3/CD7-IT) for the treatment of patients with steroid-refractory acute graft-versus-host disease (SR-aGvHD). This immunotoxin-combination causes in-vivo depletion of T- and NK-cells and regulates T-cell receptor activation. The findings of this study were published ahead of print in the Biology of Blood and Marrow Transplantation.
Patients received 4 mg/m2 CD3/CD7-IT in four 4-hour intravenous infusions administered at 48-hour intermissions. GvHD prophylaxis included cyclosporine-A alone or in combination with mycophenolate mofetil. Prophylaxis was continuously administered during treatment with CD3/CD7-IT.
This study indicates that CD3/CD7-IT is safe with “relatively low prevalence of manageable and reversible adverse events, primarily worsening of hypoalbuminemia, microangiopathy, and thrombocytopenia” for SR-aGvHD patients. Furthermore, this data suggests that CD3/CD7-IT is a promising treatment option for patients with SR-aGvHD.
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