Successful generation of fully human, second generation, anti-CD19 CAR T cells for clinical use in patients with diverse autoimmune disorders
KYV-101 manufacturing yielded a CAR T-cell product with high viability and consistent composition and functionality, regardless of disease indication, pre-treatment, and heterogeneity of the incoming material. Cryopreservation of the apheresis and final drug product enabled widespread distribution. These results support the robustness of the manufacturing process for the fully human KYV-101 anti-CD19 CAR T-cell therapy drug product for patients across diverse autoimmune disease types.
Authors
- Aiden Haghikia (ORCID: https://orcid.org/0000-0001-9629-3298)
- Jörg H. W. Distler (ORCID: https://orcid.org/0000-0001-7408-9333)
- Roland Schroers (ORCID: https://orcid.org/0000-0003-2744-5491)
- Lars Bullinger (ORCID: https://orcid.org/0000-0002-5890-5510)
- Karen Walker
- Jonathan A. Gutman (ORCID: https://orcid.org/0000-0002-1470-0716)
- Christoph Heesen (ORCID: https://orcid.org/0000-0001-8131-9467)
- Ames C. Register
- Gerhard Krönke (ORCID: https://orcid.org/0000-0002-7566-4325)
- Ranjita Sengupta
- Dimitrios Mougiakakos (ORCID: https://orcid.org/0000-0002-2817-6660)
- Sascha Dietrich
- Georg Andreas Schett (ORCID: https://orcid.org/0000-0001-8740-9615)
- Richard Alan Furie (ORCID: https://orcid.org/0000-0001-6712-1585)
- Andréas Mackensen (ORCID: https://orcid.org/0000-0002-0685-4483)
- Ralf Gold
- Michael Pendleton
- Mario Lorente
- Amber S. Podoll
- Nicolaus Kröger
- Ruthee Bayer
Institutions
- Northwell Health (US)
- Universität Hamburg (DE)
- Friedrich-Alexander-Universität Erlangen-Nürnberg (DE)
- University Hospitals of the Ruhr-University of Bochum (DE)
- Kyocera (United States) (US)
- Düsseldorf University Hospital (DE)
- Donald & Barbara Zucker School of Medicine at Hofstra/Northwell (US)
- University Medical Center Hamburg-Eppendorf (DE)
- United Therapeutics (United States) (US)
- Heinrich Heine University Düsseldorf (DE)
- University of Colorado Anschutz Medical Campus (US)
- Charité - Universitätsmedizin Berlin (DE)
- Ruhr University Bochum (DE)
- Otto-von-Guericke-Universität Magdeburg (DE)
Publication Details
- Journal
- Cytotherapy
- Published
- 2024-10-05
- DOI
- https://doi.org/10.1016/j.jcyt.2024.09.008
- Citations
- 12
- Primary Topic
- CAR-T cell therapy research
- Type
- article
- Field-Weighted Citation Impact
- 3.39