Non-Hodgkin's Lymphoma, Relapsed Clinical Trial
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)
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.
Non-Hodgkin's Lymphoma (NHL) represents the 6th most common cancer. Globally, around 165,000
new cases are diagnosed each year, with approximately 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. Maximum tolerated dose (MTD) will be
defined in a classical 3+3 dose escalation regimen.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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