Empfehlung für Leukozytapheresen zur CAR-T-Zell-Herstellung

Zusammenfassung

Autologe chimäre Antigenrezeptor-modifizierte (CAR-) T-Zellen bieten erhebliche Vorteile für Patienten mit ansonsten refraktären malignen Erkrankungen. Die derzeit zugelassenen CAR-T-Zell-Produkte werden zur Behandlung von malignen B-Zell-Erkrankungen wie akuter B-zelliger lymphatischer Leukämie (B-ALL), B-Zell-Non-Hodgkin-Lymphom und Multiplem Myelom eingesetzt. Da sich die klinischen Anwendungsmöglichkeiten für CAR-T-Zellen kontinuierlich ausweiten, müssen Behandlungszentren, die sich noch nicht mit dem therapeutischen Einsatz von Immuneffektorzellen befasst haben, die erforderlichen Kapazitäten und Fachkenntnisse aufbauen.

Die Apherese ist ein extrakorporales Verfahren, mit dem das Ausgangsmaterial für die Herstellung von CAR-T-Zellen gewonnen wird. Dieser Leitfaden enthält Überlegungen zur Feststellung der Aphereseeignung des Patienten und gibt hilfreiche Hinweise zur Durchführung des Aphereseverfahrens, um die Gewinnung der Leukozyten zur weiteren Herstellung von CAR-T-Zellen zu optimieren. Er ist jedoch kein Ersatz für die umfassende Ausbildung, die erforderlich ist, um qualitativ hochwertige Apheresen in Übereinstimmung mit nationalen und internationalen Vorschriften durchzuführen, und er ersetzt auch nicht die Notwendigkeit, die zelluläre Zusammensetzung und die biologische Sicherheit zu bewerten.

Abstract

Autologous chimeric antigen receptor-modified (CAR-) T-cells offer significant benefits for patients with otherwise refractory malignancies. The currently approved CAR-T cell products are used for the treatment of B-cell malignancies as acute B-cell lymphoblastic leukemia (B-ALL), B-cell non-Hodgkin’s lymphoma and multiple myeloma. As the clinical applications for CAR-T cells expand, hospitals that have not yet engaged in immune effector cell therapy will need to develop the necessary capacity and expertise.

Apheresis is the process that generates the starting material for CAR-T cell manufacturing. This guide provides considerations for determining the patients readiness for apheresis gives helpful hints on performing the apheresis procedure to optimize the collection of starting materials for futher processing. However, it is not a substitute for the comprehensive training required to perform high-quality apheresis collections in compliance with national and international regulations, nor does it replace the need to assess cellular composition and biological safety.

Schlüsselwörter

Chimäre Antigenrezeptor T-Zellen - unstimulierte Leukapherese - Auswaschzeiten von Medikamenten

Keywords

chimeric antigen receptor T-cells - unstimulated leukapheresis - Washout-phases of drugs

Publication History

Article published online:
21 August 2024

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