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29.01.2018 | Review

Clinical translation and regulatory aspects of CAR/TCR-based adoptive cell therapies—the German Cancer Consortium approach

verfasst von: Angela M. Krackhardt, Brigitte Anliker, Martin Hildebrandt, Michael Bachmann, Stefan B. Eichmüller, Dirk M. Nettelbeck, Matthias Renner, Lutz Uharek, Gerald Willimsky, Michael Schmitt, Winfried S. Wels, Martina Schüssler-Lenz

Erschienen in: Cancer Immunology, Immunotherapy | Ausgabe 4/2018

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Abstract

Adoptive transfer of T cells genetically modified by TCRs or CARs represents a highly attractive novel therapeutic strategy to treat malignant diseases. Various approaches for the development of such gene therapy medicinal products (GTMPs) have been initiated by scientists in recent years. To date, however, the number of clinical trials commenced in Germany and Europe is still low. Several hurdles may contribute to the delay in clinical translation of these therapeutic innovations including the significant complexity of manufacture and non-clinical testing of these novel medicinal products, the limited knowledge about the intricate regulatory requirements of the academic developers as well as limitations of funds for clinical testing. A suitable good manufacturing practice (GMP) environment is a key prerequisite and platform for the development, validation, and manufacture of such cell-based therapies, but may also represent a bottleneck for clinical translation. The German Cancer Consortium (DKTK) and the Paul-Ehrlich-Institut (PEI) have initiated joint efforts of researchers and regulators to facilitate and advance early phase, academia-driven clinical trials. Starting with a workshop held in 2016, stakeholders from academia and regulatory authorities in Germany have entered into continuing discussions on a diversity of scientific, manufacturing, and regulatory aspects, as well as the benefits and risks of clinical application of CAR/TCR-based cell therapies. This review summarizes the current state of discussions of this cooperative approach providing a basis for further policy-making and suitable modification of processes.

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Titel: Clinical translation and regulatory aspects of CAR/TCR-based adoptive cell therapies—the German Cancer Consortium approach
verfasst von: Angela M. Krackhardt
Brigitte Anliker
Martin Hildebrandt
Michael Bachmann
Stefan B. Eichmüller
Dirk M. Nettelbeck
Matthias Renner
Lutz Uharek
Gerald Willimsky
Michael Schmitt
Winfried S. Wels
Martina Schüssler-Lenz
Publikationsdatum: 29.01.2018
Verlag: Springer Berlin Heidelberg
Erschienen in: Cancer Immunology, Immunotherapy / Ausgabe 4/2018
Print ISSN: 0340-7004
Elektronische ISSN: 1432-0851
DOI: https://doi.org/10.1007/s00262-018-2119-y

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Clinical translation and regulatory aspects of CAR/TCR-based adoptive cell therapies—the German Cancer Consortium approach

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