Safety Study of the Bispecific T-cell Engager Blinatumomab (MT103) in Patients With Relapsed NHL
The purpose of this study is to determine whether a continuous infusion of Blinatumomab (MT103) is safe in the treatment of relapsed Non-Hodgkin's Lymphoma.
Furthermore, the study is intended to provide pharmacokinetic and pharmacodynamic data of Blinatumomab as well as to get first indication of tumour activity.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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)|
- Overall frequency of AEs [ Time Frame: until EoS ] [ Designated as safety issue: Yes ]
- PK and PD measurement [ Time Frame: until EoS ] [ Designated as safety issue: No ]
- Tumour response [ Time Frame: until EoS ] [ Designated as safety issue: No ]
|Study Start Date:||June 2004|
|Study Completion Date:||April 2012|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Patients receive Blinatumomab as continuous intravenous infusion over 4-8 weeks
Drug: Blinatumomab (MT103)
doses from 0.5 to 120µg/m2/24h, continuous intravenous (CIV), over 4-8 weeks
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 escalation regimen.
|Medizinische Klinik 5, Hämatologie & Internistische Onkologie, Universitätsklinikum Erlangen|
|Erlangen, Germany, 91054|
|Universitätsklinikum Essen, Klinik für Hämatologie, Medizinische Klinik und Poliklinik|
|Essen, Germany, 45147|
|Tübingen, Germany, 72076|
|Universitätsklinikum Ulm, Abteilung Innere Medizin III|
|Ulm, Germany, 89081|
|Medizinische Poliklinik der Julius-Maximilians-Universität Würzburg|
|Würzburg, Germany, 97080|
|Principal Investigator:||Ralf Bargou, MD, PhD||Medizinische Poliklinik der Julius-Maximilians-Universität Würzburg, Zentrum für Innere Medizin, Oberdürrbacherstr. 6 D-97080 Würzburg|