An Open-label, Multi-center Phase I Study to Investigate the Tolerability and Safety of a Continuous Infusion of the Bispecific T-cell Engager MT103 in Patients With Relapsed Non-Hodgkin's Lymphoma (NHL)
Non-Hodgkin's Lymphoma (NHL) represents the 6th most common cancer. Globally, around 165.000
new cases are diagnosed each year, with approx. 90.000 deaths per year. The vast majority of
NHLs are B-cell derived (90%) and express common B-cell antigens such as CD19, CD20 and
CD22. NHL can be divided into indolent (low-grade) and aggressive (high-grade) lymphomas.
Still almost all patients with advanced stage indolent disease will die from their disease.
Therefore, a high medical need exists to develop novel agents that further improve the
survival of NHL patients.
Blinatumomab (MT103) is a bispecific antibody derivative, anti-CD19 x anti-CD3, designed to
link B-cells and T-cells resulting in T-cell activation and a cytotoxic T-cell response
against CD19+ cells. Data of prior phase I studies show evidence of biological activity in
humans. In vitro and ex-vivo data suggest that a longterm presence of the drug in target
tissues may provide antitumour activity.
The study investigates the safety and tolerability of different doses of Blinatumomab
administration in a continuous infusion regimen. MTD will be defined in a classical 3+3 dose
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall frequency of AEs
Ralf Bargou, MD, PhD
Medizinische Poliklinik der Julius-Maximilians-Universität Würzburg, Zentrum für Innere Medizin, Oberdürrbacherstr. 6 D-97080 Würzburg