Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00274742
Study type Interventional
Source Amgen Research (Munich) GmbH
Contact
Status Completed
Phase Phase 1
Start date June 2004
Completion date April 2012

See also
  Status Clinical Trial Phase
Recruiting NCT05574114 - A Study of Radiation Therapy Before CAR T Cell Therapy for People With B Cell Lymphoma Phase 1
Recruiting NCT04603872 - CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Hematological Malignancies Early Phase 1
Completed NCT04030195 - Dose-escalation Study of Safety of PBCAR20A in Subjects With r/r NHL or r/r CLL/SLL Phase 1/Phase 2
Terminated NCT04844086 - RPM CD19-mbIL15-CAR-T Cells in Patient With Advanced Lymphoid Malignancies Phase 1
Recruiting NCT05054257 - CART19 Cells Effects in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma Phase 1
Recruiting NCT03623087 - SIMPLE Chemotherapy for NK Lymphoma/Leukaemia Phase 3
Recruiting NCT05650580 - TR115 in Patients With Relapsed / Refractory Non-Hodgkin's Lymphoma or Advanced Solid Tumors Phase 1
Not yet recruiting NCT05779930 - Safety and Feasibility of CD19 CAR T Cells Using CliniMACS Prodigy for Relapsed/Refractory CD19 Positive ALL and NHL Early Phase 1