Projectpartners

Dr. Georg Rauser
Senior Project Manager Cell and Gene Therapy,
Miltenyi Biotec GmbH (Coordinator)

Miltenyi Biotec GmbH, located in Bergisch Gladbach with its subsidiaries and affiliated companies, is a global biotech company with more than 2000 employees in 25 countries. Since its foundation in 1989, the company has pioneered biomedical research and cellular therapy. With its products and services, Miltenyi Biotec supports scientists worldwide in basic, translational and clinical research. The integrated product portfolio includes instruments and reagents for sample preparation, cell separation, flow cytometry, cell culture, molecular analysis and pre-clinical imaging. In the medium term, the company's aim is to establish innovative cellular therapies as the standard for the treatment of hitherto incurable cancers.

Miltenyi is coordinator of CD20 CAR-TIME and sponsor of the clinical trial. Additionally, Miltenyi is responsible for performance of the pre-clinical studies, automated CAR-T cell-production-process-development, GMP-vector production and patient sample monitoring as well as co-development of quality control procedures.

Prof. Dr. Ulrike Köhl
Director Institute of Cellular Therapeutics,
Hannover Medical School

The Institute of Cellular Therapeutics of the Hannover Medical School under the direction of Prof. Dr. Ulrike Köhl is co-responsible for the manufacturing and QC of the test drug.

The GMP Development Unit (Good Manufacturing Practice, GMPDU) is as core facility of MHH substantially involved during the development phase and in the continuation of the project.

The Cellular Therapy Centre (CTC) is responsible for the production of the investigational drug within the project in compliance with the German Medicines Act. It is responsible for the extension of the existing official manufacturing permit in accordance with §13 AMG (German Medicines Act) to include the intended investigational drug.

Prof. Dr. Hinrich Abken
Chair Genetic Immunotherapy
RCI Regensburg Center for Interventional Immunology
University Regensburg

Genetic Immunotherapy is a research laboratory of molecular tumor immunology with a special focus on the development of immunotherapeutic strategies for the treatment of tumors and the translation of this strategy into clinical trials.

The aim of our work is to increase the efficiency, tolerability and sustainability of the adoptive immune therapy of tumors.

Within CD20 CAR-TIME the University Regensburg is performing analyses to examine the behavior of modified immune cells in mouse models and in patients to understand and improve the therapeutic effects and to develop new applications.

Workpackage leaders

WP1 Preclinical research

Dr. Andrew Kaiser
Miltenyi Biotec GmbH

WP2 Cell manufacturing & quality control

Dr. med. Lubomir Arseniev
Head of Cellular Therapy Centre,
Hannover Medical School

Dr. Iris Bürger
Miltenyi Biotec GmbH

Dr. Ruth Esser
Head of ATMP research and development
Hannover Medical School

WP3 Clinical trial

Christine Schubert
Miltenyi Biotec GmbH

WP4 Concomitant research & Monitoring

Prof. Dr. Hinrich Abken
Chair Genetic Immunotherapy
RCI Regensburg Center for Interventional Immunology
University Regensburg

Dr. Anne Richter
Miltenyi Biotec GmbH

Dr. Christiane Siewert,
Miltenyi Biotec GmbH

WP5 Project management

Patricia Marschall
Miltenyi Biotec GmbH

Investigators

Prof. Dr. Peter Borchmann
Head of Lymphoma Program
Co-Chairman GHSG
University Hospital Cologne

PD Dr. Dr. med. Udo Holtick
Head BMT outpatient clinic and apheresis unit, Stem Cell Transplantation Program
Dept. I of Internal Medicine
University Hospital Cologne

Prof. Dr. med. Dr. rer. nat.
Michael von Bergwelt

Director Department of Medicine III
Hospital of the Ludwig-Maximilians-University, Munich

Prof. Dr. med. Sebastian Theurich
Department of Medicine III
Hospital of the Ludwig-Maximilians-University, Munich

PD Dr. Max Schlaak
Department of Dermatology and Allergy
Hospital of the Ludwig-Maximilians-University, Munich

Scientific advisory board

Carl H. June, MD,
Professor in Immunotherapy

Perelman School of Medicine

Prof. Dr. Ulrich Kalinke
Hannover Medical School

Dr. Waseem Qasim
Professor of Cell & Gene Therapy

Great Ormond Street Hospital for Children