Flagship projects
European consortia
The Chair for Cellular Immunotherapy is part of these European consortia funded by the EU.
EU Project imSAVAR
Nonclinical mimicking of the immune system effects of immunomodulatory therapies. The imSAVAR project aims to deliver a range of tools that will enhance our ability to assess the efficacy and safety of immunomodulatory therapies.
We also plan to develop new biological markers for diagnosing and predicting immune-mediated safety issues, and explore ways of mitigating them. Please find out more about the initial challenge, our approach, and objectives, as well as the intended impact below.
Further information about the project
Funding
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 853988. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA and JDRF INTERNATIONAL.
More information about the EU Project imSAVAR.
EU Project T2EVOLVE
The key objective of T2EVOLVE is to accelerate development and increase awareness and access of cancer patients to immunotherapy with immune cells that harbor a genetically engineered T-cell receptor (TCR) or synthetic chimeric antigen receptor (CAR).
Simultaneously, T2EVOLVE aims to provide guidance on sustainable integration of these treatment into the EU healthcare system.
Further information about the project
Funding
This project receives funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 945393. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation program and EFPIA.
Related publication
Katrin Mestermann , Marie Eichler, Markus Machwirth, Kati Kebbel, Ulrike Köhl, Hermann Einsele, Claudia Müller, Jörg Lehmann, Tamás Raskó, Felix Lundberg, Zsuzsanna Izsvák, Gerno Schmiedeknecht, Michael Hudecek (2020)
P108 Clinical-grade Manufacturing of ROR1 CAR T-cells using a Novel virus-free Protocol. In: The 46th Annual Meeting of the European Society for Blood and Marrow Transplantation: Physicians Poster Session (P001-P706). Bone Marrow Transplantation volume 55, pages181–714(2020).
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More information about the EU Project T2EVOLVE.
EU Project AIDPATH
AIDPATH aims to facilitate patients access to CAR T cell therapy by creating a fully automated CAR T cell manufacturing pipeline that can be placed in the hospital itself.
Further information about the project
Funding
AIDPATH grant (Horizon 2020)
Related publication
Fraunhofer-Institut für Produktionstechnologie IPT (2021)
Pressemitteilung. Individualisierte Krebstherapie dank künstlicher Intelligenz bald schneller und effektiver.
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SmartCAR-T
SLAMF7-CAR T cells prepared by Sleeping Beauty gene-transfer for immunotherapy of multiple myeloma – a rare hematologic disease. Eleven partners in six European countries have closely collaborated to transfer the CAR-T “Breakthrough Therapy” from bench to bedside.
We anticipate that SmartCAR-T cells will confer more potent and durable antitumor reactivity. We will deliver a platform that can be rapidly adjusted to other tumor types. The TME-response functions are integrated into SmartCAR-T cells as a ‘stand alone, single shot treatment’ without the need for expensive combination therapy. This allows scalable economic production and broad patient access in a sustainable way for health care systems.
Further information about the project
Funding
Co-funded by Horizon 2020
Related publication
Prommersberger S, Reiser M, Beckmann J, Danhof S, Amberger M, Quade-Lyssy P, Einsele H, Hudecek M, Bonig H, Ivics Z. CARAMBA: a first-in-human clinical trial with SLAMF7 CAR-T cells prepared by virus-free Sleeping Beauty gene transfer to treat multiple myeloma.Gene Ther. 2021 Sep;28(9):560-571. doi: 10.1038/s41434-021-00254-w. Epub 2021 Apr 13. PMID: 33846552; PMCID: PMC8455317.
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EU Project CARAMBA
SLAMF7-CAR T cells prepared by Sleeping Beauty gene-transfer for immunotherapy of multiple myeloma – a rare hematologic disease. Eleven partners in six European countries have closely collaborated to transfer the CAR-T “Breakthrough Therapy” from bench to bedside.
Further information about the project
Website
EU Project CARAMBA
Video: CARAMBA EU project: SLAMF7 CAR-T treatment of multiple myeloma (Link to YouTube)
Funding
CARAMBA grant (Horizon 2020)
Related publication
Prommersberger S, Reiser M, Beckmann J, Danhof S, Amberger M, Quade-Lyssy P, Einsele H, Hudecek M, Bonig H, Ivics Z. CARAMBA: a first-in-human clinical trial with SLAMF7 CAR-T cells prepared by virus-free Sleeping Beauty gene transfer to treat multiple myeloma.
Gene Ther. 2021 Sep;28(9):560-571. doi: 10.1038/s41434-021-00254-w. Epub 2021 Apr 13. PMID: 33846552; PMCID: PMC8455317.
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CERTAINTY
CERTAINTY develops virtual twins to support CAR T cell therapy in cancer treatment. Virtual twins are data-driven digital models representing a patient’s health or disease state, designed to simulate and predict individual responses to therapy. The approach aims to provide clinicians with actionable insights to inform treatment decisions and improve personalized cancer care.
Further information about the project
Website
https://www.certainty-virtualtwin.eu/
Funding
EU Grant No. 101136379
Related publication
Weirauch U, Kreuz M, Birkenbihl C, Alb M, Quaranta M, Calzone L, Orozco-Ruiz S, Binder S, Fischer L, Clavreul S, Maguri M, Ferle M, Rade M, Azarias G, Hydren JR, Jamarik J, Schwarz D, Sebestyen Z, Kuball J, Popp G, Antoine C, Knockaert M, Schoeder CT, Fandrei D, Sanges C, Radvilas V, Gagelmann N, Rückert M, Penack O, Fricke S, Schmidt A, Ward C, Steinbeisser C, Van Gyseghem JM, Niarakis A, Garderet L, Hudecek M, Neumuth T, Platzbecker U, Köhl U, Demlova R, Kremer A, Franke S, Fröhlich H, Merz M, Reiche K; CERTAINTY Consortium. Design specifications for biomedical virtual twins in engineered adoptive cellular immunotherapies. NPJ Digit Med. 2025 Aug 1;8(1):493. doi: 10.1038/s41746-025-01809-6. PMID: 40750653; PMCID: PMC12316993.
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All publications
https://www.certainty-virtualtwin.eu/publications
JOIN4ATMP
The JOIN4ATMP project aims to accelerate and de-risk European ATMP development and ensure wide-spread access of ATMPs, through the mapping of obstacles to such development, the audit of real-world-based solutions and the definition of new paths forward.
Further information about the project
Website
https://join4atmp.eu/
Funding
EU funded
Related publication
https://join4atmp.eu/insights/publications
EASYGEN
EASYGEN is a collaborative EU project aiming to optimize hospital workflows of CAR-T cell therapy for a sustainable healthcare workforce. It brings together 18 international partners from academia and industry, and is led by Fresenius SE & Co.KGaA and Fraunhofer IZI as academic co-lead.
Further information about the project
Website
https://www.easygen-consortium.eu/
Funding
Innovative Health Initiative funded
Clinical trials
LION-1 Study
Principal investigator of the LION-1 trial is Prof. Hermann Einsele, Director of the Department of Medicine II at University Hospital Würzburg. Prof. Michael Hudecek is the sponsor representative of the study, Prof. Sophia Danhof leads the clinical treatment. The study is being conducted at the newly established Clinical Trial Center of the NCT WERA.
Further information about the project
Press releases
Fraunhofer-Gesellschaft
Advances in Cancer Treatment: CAR T Cells Fight Solid Tumors (2025)
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University Hospital Würzburg
First Patient in the LION-1 Trial Receives ROR1-Targeted CAR-T Cell Therapy
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Related publications
Miskey C, Friedel S, Mestermann K, & Hudecek M, Ivics Z. (2023). HTLV-1 Splice Sites in Prevalent Gene Vectors Cause Splicing Perturbations in Transgenic Human Cells. 10.1101/2023.01.28.526022.
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Prommersberger S, Monjezi R, Botezatu L, Miskey C, Amberger M, Mestermann K, Hudecek M, Ivics Z. Generation of CAR-T Cells with Sleeping Beauty Transposon Gene Transfer. Methods Mol Biol. 2022;2521:41-66. doi: 10.1007/978-1-0716-2441-8_3.
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Peng H, Nerreter T, Mestermann K, Wachter J, Chang J, Hudecek M, Rader C. ROR1-targeting switchable CAR-T cells for cancer therapy. Oncogene. 2022;41(34):4104-4114.
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Mestermann K, Giavridis T, Weber J, Rydzek J, Frenz S, Nerreter T, Mades A, Sadelain M, Einsele H, Hudecek M. The tyrosine kinase inhibitor dasatinib acts as a pharmacologic on/off switch for CAR T cells. Sci Transl Med. 2019;11:eaau5907.
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CARAMBA Study
The clinical trial within CARAMBA is designed as a Phase I/II trial. Phase I is a dose escalation study and will explore the effective dose of the CAR-T cell product. For the Phase II part of the trial, 25 patients will be treated with the maximum tolerated dose of SLAMF7 CAR-T.
Further information about the project
Website
https://www.caramba-cart.eu/patients/
Also see the EU project CARAMBA above