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ReSHAPE HOME

The ReSHAPE project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement n. 825392

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ReSHAPE aims at transforming the treatment of patients suffering from undesired Immunity/Inflammation (Allotransplantation, Autoimmunity, Hyperinflammation, and Regenerative Medicine, including Gene Therapy) who presently have limited curative treatment options by applying next-generation Treg approaches that overcome the limitations of 1st generation Treg product developments.

ReSHAPE will use Treg therapy as a very promising new tool for reshaping undesired inflammation/immunity applicable in many disease situations with high unmet medical need which can be used as role model for any approach of next-generation ATMP (Advanced Therapy Medicinal Product).

ReSHAPE will create different platforms, such as a knowledge platform based on previous work of the consortium but also on applying new technology and medical approaches for improved Treg therapies, including next-generation Treg product platform, novel preclinical testing platform, clinical development and clinical trial platform, including accompanying biomarker studies, as well as a HTA/exploitation platform. The platforms comprise the components and expertise necessary to create a solid foundation on which to build new therapeutic Treg approaches and cell products beyond Treg and aim at overcoming particular development bottlenecks.

The ReSHAPE consortium will develop next-generation Treg products and will prove next-generation approaches in clinical trials.

ReSHAPE´s next-generation Treg therapy approaches are applicable for organ and hematopoetic stem cell transplantation and beyond in many medical indication fields, such as Autoimmunity, Hyperinflammation, and Regenerative Therapies, including Gene Therapies.

ReSHAPE´s next-generation Treg approaches will translate a significant technology progress in the advanced therapy field from early development to First-In-Human (FIH) clinical trials with a concept for moving forward further in the added value chain of ATMP implementation.

ReSHAPE NEWS

 

2024
05-06December

Final meeting in Berlin on 05-06 December 2024 - SAVE THE DATE!

04August

04 August 2024 - ProTreg study First patient in

We are excited to announce the enrollment of our first patient in the ProTreg study, marking a significant milestone in our journey to advance healthcare.


The “ProTreg Trial” will assess therapeutic feasibility, safety, tolerability and data suggestive of preliminary efficacy of Treg therapy with our polyclonally expanded Treg product as adjunct immunosuppressive treatment in deceased donor kidney transplants. The study aims to determine if administering deceased donor kidney transplants recipients with polyclonal ex-vivo expanded autologous Treg is safe. Moreover, we want to investigate if adoptive Treg therapy modulates the immunological response such that the kidney transplant is accepted and facilitates the immunosuppression maintenance therapy tapering or obviate it, thereby improving recipients’ long-term clinical outlook.

08February

TregTacRes has been selected by EMA as part of the Pilot for academic and non-profit developers of advanced therapy medicines.

It's a great success for us that we now benefit directly from the expertise of the EMA and thus have an (even) greater chance of turning our project into reality! The aim of the pilot is to guide non-commercial developers of promising ATMPs addressing unmet medical needs through the regulatory and scientific requirements in the European Union (EU) and better understand their needs to enable them to advance the development of their medicines and eventually reach the marketing authorisation application stage.


READ THE FULL ARTICLE
2023
18-19September

ReSHAPE Fourth Annual Meeting, 18-19 September 2023 in Berlin.

2022
26-27April

ReSHAPE Third Annual Meeting, 26-27 April 2022 (online event hosted by Innovation Acta)

2021
10-11March

ReSHAPE Second Annual Meeting, 10-11 March 2021 (online event hosted by Innovation Acta)

2020
23-24January

ReSHAPE First Annual Meeting, 23-24 January 2020 Berlin, Germany

2019
25-26November

ReSHAPE participates to RESTORE 1ATSM in Berlin

Prof. Petra Reinke project Coordinator will give the talk “Reshape immune balance by next-generation regulatory T cells”

In the programme talks of Hans Dieter Volk (Charité), Julia Polansky-Biskup (Charité), Leila Amini (Charité), Joanna Hester (UOXF)

07February

ReSHAPE Kick Off Meeting, 07-08 February in Berlin (Germany)

30January

ReSHAPE website online

ReSHAPE PROJECT

PROJECT | OBJECTIVES | WORK ORGANIZATION | GLOSSARY

Members of the consortium are pioneers in the development of Treg therapy from basic science to very recent encouraging First-In-Human (FIH) clinical trials of 1st generation Treg products. They have a longtrack record of collaboration, including EC-funded projects (e.g. IOT, RISET, One Study, BIO-DrIM). The first clinical trials were performed to combat organ transplant rejection and Graft-versus-Host Disease (GvHD) post allo-HSC transplantation. However, promising preclinical studies offer a broad application field of Treg therapy beyond allotransplantation.

project

Based on our extensive preclinical and first clinical data, we identified several opportunities for improving Treg therapy which will be addressed by ReSHAPE:

  • Redirecting antigen specificity by CAR/TCR-Treg
  • Enhanced functional stability of Treg under in vivo challenges by innovative genetic and epigenetic modifications of Treg
  • Support of Treg engraftment in vivo by particular conditioning of the recipients and/or enabling Treg to secrete their own growth factors
  • New in vitro & in vivo tools for in-depth characterisation of Treg product candidates for better standardisation of the manufacturing process and preclinical PoC studies with enhanced predictive value for derisking clinical development
  • Clinical trials accompanied by a broad portfolio of highly standardised biomarkers to better understand the complex “living” medicinal products regarding their therapy response, such as PK/PD, safety, mode-of-action, putative surrogate markers of efficacy.
  • Research to generate innovative clinical development roadmaps and early health economic assessment to support the development of business models for next level of clinical development and commercial exploration of innovations

 


TREG CELLS

State of Art

Dynamic tissue homeostasis is based on the crosstalk of intratissue parenchymal, stromal, and immune cells that is guided by the extracellular matrix “code” and regulated in a bi(multi)-directional way. Acute and chronic events such as trauma, ischemia/reperfusion injury, (auto/allo)-immune attack, challenge the homeostasis and result in adaptive processes, including further cellular recruitment. The fate of the tissue response is not only influenced by the strength and duration of the challenges but also by disease modifiers, such as age, malformation, metabolic disbalance.

It is becoming more and more clear that the intratissue balance of inflammation/immunity has a major impact on maintenance/restoration of tissue homeostasis by controlling the state and fate of progenitor/stem/ stromal cells and extracellular matrix dynamics.

Thymically derived FOXP3+ regulatory T cells (tTreg) constitute a unique T cell lineage that is essential for maintaining immune tolerance to self as well as innocuous environmental antigens and intratissue immune homeostasis. However, FOXP3 can also be turned on in conventional T cells with effector functions (Teff) as consequence of antigen exposure in the periphery, under both non-inflammatory and inflammatory conditions. These so-called peripheral Treg (pTreg) that involve both CD4+ and CD8+ pTreg cells, participate in the control of immunity at sites of inflammation. Both tTreg and pTreg can control inflammation/immunity by multiple mechanisms, such as i) competition with Teff for IL-2, ii) through cAMP-mediated immunosuppression, iii) adenosine production via the ectoenzymes, CD39 and CD79, iv) secretion of inhibitory cytokines (e.g. IL-10, TGF-ß, IL-33, IL-34), and v) cytolysis of Teff via granzyme/perforin-dependent mechanisms.

Diminished number and/or function of Treg, e.g. by malformation (e.g. IPEX syndrome), and disbalanced Teff/Treg ratio at the site of inflammation result in unwanted inflammation/immunity associated with autoimmunity, autoinflammation, and disturbed regeneration from trauma and ischemia/reperfusion. Consequently, agonistic targeting of Treg is a promising therapeutic option to combat undesired inflammation/immunity in a broad range of medical indications. Although in vivo Treg induction/expansion approaches, such as blocking co-stimulatory signals during antigen exposure, tolerogenic dendritic cells, tolerogenic peptide vaccination, and low-dose IL-2 show some efficacy in preclinical models and First-In-Human trials, their efficacy is limited and some adverse effects can be observed. In many preclinical models, the adoptive transfer of Treg is more effective. The recent (bio) technological advances to isolate and expand human Treg under GMP compliant conditions, now allow adoptive Treg therapy to be introduced to the clinic, opening up new opportunities.

Treg products (with or without genetic manipulation) for the adoptive transfer are regulatory categorized as Advanced Therapy Medicinal Product (ATMP). ATMP therapies are based on gene, cell or tissue-engineered products which are defined according to the terms of Regulation 1394/2007. So far, only a small number of these products have been placed on the market, not a single Treg product so far.

The ReSHAPE consortium will develop next-generation Treg products and will prove next-generation approaches in clinical trials.

objectives

ReSHAPE PARTNERSHIP

CONSORTIUM | PARTNERS | CONTACTS | RESERVED AREA

The ReSHAPE consortium is coordinated by the Charité – Universitätsmedizin Berlin. The project coordinator is MD Petra Reinke, Professor of Nephrology and Transplantation within the following scientific topics: transplantation medicine, development of new diagnostic and therapeutic approaches in transplantation (non-invasive immune Biomarkers, detection and targeting of memory T cells and adoptive Teff/Treg T cell therapy) and founding director of the Berlin Center for Advanced Therapies (BeCAT) that 2017 received in a highly competitive procedure a 30 Mio € funding by the German Council of Science and Humanities.




ReSHAPE EVENTS

ReSHAPE Third Annual Meeting, 26-27 April 2022
pin Online event hosted by Innovation Acta




ReSHAPE Second Annual Meeting, 10-11 March 2021
pin Online event hosted by Innovation Acta




ReSHAPE First Annual Meeting, 23-24 January 2020
pin Berlin (Germany)




ReSHAPE Kick Off Meeting, 07-08 February 2019
pin Berlin (Germany)


MEETING DOCUMENTS

pdf   List of Participants

ReSHAPE DISSEMINATION

PUBLICATIONS | CONFERENCES | PRESS RELEASES

  1. Léa Flippe, Séverine Bézie, Ignacio Anegon,vCarole Guillonneau.
    Future prospects for CD8+ regulatory T cells in immune tolerance.
    Immunological reviews, 2019, 292, 1-16, DOI: 10.1111/imr.12812.
    → open it on the web
  2. Séverine Ménoret, Laure-Hélène Ouisse, Laurent Tesson, Séverine Remy, Claire Usal, Aude Guiffes, Vanessa Chenouard, Pierre-Joseph Royer, Gwenaelle Evanno, Bernard Vanhove, Eliane Piaggio, and Ignacio Anegon.
    In vivo analysis of human immune responses in immunodeficient rats.
    Transplantation, 2020, 104/4, 715-723, DOI: 10.1097/tp.0000000000003047.
    → open it on the web
  3. George Adigbli, Séverine Ménoret, Amy R Cross, Joanna Hester, Fadi Issa, Ignacio Anegon.
    Humanization of immunodeficient animals for the modelling of transplantation, graft-versus host disease and regenerative medicine.
    Transplantation, ahead of print , DOI: 10.1097/tp.0000000000003177.
    → open it on the web
  4. Enrico Fritsche, Hans-Dieter, Volk Petra Reinke, Mohamed Abou-El-Enein.
    Toward an optimized process for clinical manufacturing of chimeric antigen receptor regulatory T-cell therapy (CAR-Treg) Trends in Biotechnology.
    Trends in Biotechnology, 2020, 1-13 , DOI: 10.1016/j.tibtech.2019.12.009.
    → open it on the web
  5. Enrico Fritsche, Magdi Elsallab, Michaela Schaden,Spencer Phillips Hey, Mohamed Abou-El-Enein.
    Post-marketing safety and efficacy surveillance of cell and gene therapies in the EU: A critical review.
    Cell & Gene Therapy Insights, 2019; 5(11), 1505–1521, DOI: 10.18609/cgti.2019.156.
    → open it on the web
  6. Matthew Brook, Joanna Hester, Fadi Issa.
    New frontiers: cellular immunotherapy beyond cancer.
    Cell and Gene Therapy Insights, 2019, 1229-1236, DOI: 10.18609/cgti.2019.163.
    → open it on the web
  7. Leila Amini, Jenny Greig, Michael Schmueck-Henneresse, Hans-Dieter Volk, Séverine Bézie, Petra Reinke, Carole Guillonneau, Dimitrios L Wagner, Ignacio Anegon.
    Super-Treg: Toward a New Era of Adoptive Treg Therapy Enabled by Genetic Modifications.
    Frontiers in Immunology, 2021, 611638, DOI: 10.3389/fimmu.2020.611638. Open Access.
    → open it on the web
  8. Maja Pizevska, Jaspal Kaeda, Enrico Fritsche, Hisham Elazaly, Petra Reinke, Leila Amini.
    Advanced Therapy Medicinal Products' Translation in Europe: A Developers' Perspective.
    Frontiers in Medicine, 2022, 757647, DOI:10.3389/fmed.2022.757647. Open Access.
    → open it on the web
  9. Nadège Vimond, Juliette Lasselin, Ignacio Anegon, Carole Guillonneau, Séverine Bézie.
    Genetic engineering of human and mouse CD4+ and CD8+ Tregs using lentiviral vectors encoding chimeric antigen receptors.
    Molecular Therapy - Methods & Clinical Development, 2021, 69-85, DOI: 10.1016/j.omtm.2020.11.008. Open Access.
    → open it on the web
  10. Laura Elisa Buitrago-Molina, Julia Pietrek, Fatih Noyan, Jerome Schlue, Michael P. Manns, Heiner Wedemeyer, Matthias Hardtke-Wolenski, Elmar Jaeckel.
    Treg-specific IL-2 therapy can reestablish intrahepatic immune regulation in autoimmune hepatitis.
    Journal of Autoimmunity, 2021, 102591, DOI: 10.1016/j.jaut.2020.102591.
    → open it on the web
  11. Daniel Kaiser, Natalie Maureen Otto, Oliver McCallion, Henrike Hoffmann, Ghazaleh Zarrinrad, Maik Stein, Carola Beier, Isabell Matz, Marleen Herschel, Joanna Hester, Guido Moll, Fadi Issa, Petra Reinke, Andy Roemhild.
    Freezing Medium Containing 5% DMSO Enhances the Cell Viability and Recovery Rate After Cryopreservation of Regulatory T Cell Products ex vivo and in vivo.
    Frontiers in Cell and Developmental Biology, 2021, 750286, DOI: 10.3389/fcell.2021.750286.
    → open it on the web
  12. Kristy Ou, Dania Hamo, Anne Schulze, Andy Roemhild, Daniel Kaiser, Gilles Gasparoni, Abdulrahman Salhab, Ghazaleh Zarrinrad, Leila Amini, Stephan Schlickeiser, Mathias Streitz, Jörn Walter, Hans-Dieter Volk, Michael Schmueck-Henneresse, Petra Reinke, Julia K Polansky.
    Strong Expansion of Human Regulatory T Cells for Adoptive Cell Therapy Results in Epigenetic Changes Which May Impact Their Survival and Function.
    Frontiers in Cell and Developmental Biology, 2021, 751590, DOI: 10.3389/fcell.2021.751590. Open Access.
    → open it on the web
  13. Sybille Landwehr-Kenzel, Anne Zobel, Isabela Schmitt-Knosalla, Anne Forke, Henrike Hoffmann, Michael Schmueck-Henneresse, Robert Klopfleisch, Hans-Dieter Volk, Petra Reinke.
    Cyclosporine A but Not Corticosteroids Support Efficacy of Ex Vivo Expanded, Adoptively Transferred Human Tregs in GvHD.
    Frontiers in Immunology, 2021, 716629, DOI: 10.3389/fimmu.2021.716629. Open Access.
    → open it on the web
  14. Dimitrios Laurin Wagner, Lena Peter, Michael Schmueck-Henneresse.
    Cas9-directed immune tolerance in humans-a model to evaluate regulatory T cells in gene therapy?
    Gene Therapy, 2021, 549-559, DOI: 10.1038/s41434-021-00232-2. Open Access.
    → open it on the web
  15. Jonas Kath, Weijie Du, Bernice Thommandru, Rolf Turk, Leila Amini, Maik Stein, Tatiana Zittel, Stefania Martini, Lennard Ostendorf, Andreas Wilhelm, Levent Akyüz, Armin Rehm, Uta E. Höpken, Axel Pruß, Annette Künkele, Ashley M. Jacobi, Hans-Dieter Volk, Michael SchmueckHenneresse, Petra Reinke, Dimitrios L. Wagner.
    Fast, efficient and virus-free generation of TRAC-replaced CAR T cells.
    BioRxiv, 2021, DOI: 10.1101/2021.02.14.431017. Open Access.
    → open it on the web
  16. Andy Roemhild, Natalie Maureen Otto, Guido Moll, Mohamed Abou-El-Enein, Daniel Kaiser, Gantuja Bold, Thomas Schachtner, Mira Choi, Robert Oellinger, Sybille Landwehr-Kenzel, Karsten Juerchott, Birgit Sawitzki, Cordula Giesler, Anett Sefrin, Carola Beier, Dimitrios Laurin Wagner, Stephan Schlickeiser, Mathias Streitz, Michael Schmueck-Henneresse, Leila Amini, Ulrik Stervbo, Nina Babel, Hans-Dieter Volk, Petra Reinke.
    Regulatory T cells for minimising immune suppression in kidney transplantation: phase I/IIa clinical trial.
    British Medical Journal, 2020, DOI: 10.1136/bmj.m3734. Open Access.
    → open it on the web
  17. Christopher Kressler, Gilles Gasparoni, Karl Nordström, Dania Hamo, Abdulrahman Salhab, Christoforos Dimitropoulos, Sascha Tierling, Petra Reinke, Hans-Dieter Volk, Jörn Walter, Alf Hamann and Julia K. Polansky.
    Targeted De-Methylation of the FOXP3-TSDR Is Sufficient to Induce Physiological FOXP3 Expression but Not a Functional Treg Phenotype.
    Frontiers in Immunology, 2021, 609891, DOI: 10.3389/fimmu.2020.609891. Open Access.
    → open it on the web
  18. Christina Iwert, Julia Stein, Christine Appelt, Katrin Vogt, Roman Josef Rainer, Katja Tummler, Kerstin Mühle, Katarina Stanko, Julia Schumann, Doreen Uebe, Karsten Jürchott, Jan Lisec, Katharina Janek, Christoph Gille, Kathrin Textoris-Taube, Somesh Sai, Ansgar Petersen, Anja A. Kühl, Edda Klipp, Christian Meisel, Birgit Sawitzki.
    TCAIM controls effector T cell generation by preventing Mitochondria-Endoplasmic Reticulum Contact Site-initiated Cholesterol Biosynthesis.
    BioRxiv, 2021, DOI: 10.1101/2021.04.20.440500. Open Access.
    → open it on the web
  19. Helen L. Stark, Hayson C. Wang, Jasmina Kuburic, Alaa Alzhrani, Joanna Hester and Fadi Issa.
    Immune Monitoring for Advanced Cell Therapy Trials in Transplantation: Which Assays and When?
    DOI https://doi.org/10.3389/fimmu.2021.664244.
    → open it on the web
  20. Conor Hennessy, Guido Lewik, Amy Cross, Joanna Hester, Fadi Issa.
    Recent advances in our understanding of the allograft response.
    Faculty Reviews 2021, 10:21 DOI: https://doi.org/10.12703/r/10-21.
    → open it on the web
  21. Sabrina Wright, Conor Hennessy,Joanna Hester, Fadi Issa.
    Chimeric Antigen Receptors and Regulatory T Cells: The Potential for HLA-Specific Immunosuppression in Transplantation.
    Engineering 2021 DOI https://doi.org/10.1016/j.eng.2021.10.018.
    → open it on the web
  22. Alaa Alzhrani , Matthew Bottomley, Kathryn Wood, Joanna Hester, Fadi Issa.
    Identification, selection, and expansion of non-gene modified alloantigen-reactive Tregs for clinical therapeutic use. Cellular Immunology 2020, 357, 104214. DOI https://doi.org/10.1016/j.cellimm.2020.104214.
    → open it on the web
  23. Author perspective for publication on BMJ Opinion
    → open it on the web
  24. Amini L, Wagner DL, Rössler U, Zarrinrad G, Wagner LF, Vollmer T, Wendering DJ, Kornak U, Volk HD, Reinke P and Schmueck-Henneresse M.
    CRISPR-Cas9-Edited Tacrolimus-Resistant Antiviral T Cells for Advanced Adoptive Immunotherapy in Transplant Recipients. Molecular Therapy (Cell Press) 2020 DOI https://doi.org/10.1016/j.ymthe.2020.09.011.
    → open it on the web
  25. Constantin J Thieme , Mohamed Abou-El-Enein, Enrico Fritsche, Moritz Anft, Krystallenia Paniskaki, Sarah Skrzypczyk, Adrian Doevelaar, Magdi Elsallab, Nicola Brindle, Arturo Blazquez-Navarro, Felix S Seibert, Toni L Meister, Stephanie Pfaender, Eike Steinmann, Oliver Witzke, Timm H Westhoff, Ulrik Stervbo, Guido Heine, Toralf Roch, Nina Babel.
    Detection of SARS-CoV-2-specific memory B cells to delineate long-term COVID-19 immunity. Allergy 2021 Aug;76(8):2595-2599 DOI https://doi.org/10.1111/all.14827.
    → open it on the web
  26. Matthew J.Bottomley, Matthew O.Brook,Sushma Shankar, Joanna Hester, Fadi Issa.
    Towards regulatory cellular therapies in solid organ transplantation.
    DOI https://doi.org/10.1016/j.it.2021.11.001. NO Open Access.
    → open it on the web
  27. Richard Taubert, Bastian Engel, Jana Diestelhorst, Katharina L. Hupa-Breier, Patrick Behrendt, Niklas T. Baerlecken, Kurt-Wolfram Sühs, Maciej K. Janik, Kalliopi Zachou, Marcial Sebode, Christoph Schramm, María-Carlota Londoño, Sarah Habes, the UK-AIH Consortium, Ye H. Oo, Claudine Lalanne, Simon Pape, Maren Schubert, Michael Hust, Stefan Dübel, Mario Thevis, Danny Jonigk, Julia Beimdiek, Falk F. R. Buettner, Joost P. H. Drenth, Luigi Muratori, David H. Adams, Jessica K. Dyson, Amédée Renand, Isabel Graupera, Ansgar W. Lohse, George N. Dalekos, Piotr Milkiewicz, Martin Stangel, Benjamin Maasoumy, Torsten Witte, Heiner Wedemeyer, Michael P. Manns, Elmar Jaeckel.
    Quantification of polyreactive immunoglobulin G facilitates the diagnosis of autoimmune hepatitis. Hepatology 2021 DOI https://doi.org/10.1002/hep.32134.
    → open it on the web
  28. Janine Dywicki, Laura Elisa Buitrago-Molina, Fatih Noyan, Jerome Schlue, Konstantinos Iordanidis, Michael P. Manns, Heiner Wedemeyer, Elmar Jaeckel, Matthias Hardtke-Wolenski.
    Splenectomy induces biochemical remission and regeneration in experimental murine autoimmune hepatitis. European Journal of Medical Research 2022 DOI https://doi.org/10.1186/s40001-022-00933-3.
    → open it on the web
  29. Jakob Kremer, Pierre Henschel, Daniel Simon, Tobias Riet, Christine Falk, Matthias Hardtke-Wolenski, Heiner Wedemeyer, Fatih Noyan, Elmar Jaeckel.
    Membrane-bound IL-2 improves the expansion, survival, and phenotype of CAR Tregs and confers resistance to calcineurin inhibitors. Front Immunol 2022 DOI https://doi.org/10.3389/fimmu.2022.1005582.
    → open it on the web
  30. Nail Benallegue , Bryan Nicol , Juliette Lasselin , Severine Bézie , Lea Flippe , Hadrien Regue , Nadege Vimond , Severine Remy , Alexandra Garcia , Fabienne Le Frère , Ignacio Anegon , David Laplaud , Carole Guillonneau.
    Severe Multiple Sclerosis patients exhibit functionally altered CD8+ regulatory T cells. Neurol Neuroimmunol Neuroinflamm 2022 DOI https://doi.org/10.1212/NXI.0000000000200016.
    → open it on the web
  31. Dimitrios L Wagner, Ulrike Koehl, Markus Chmielewski, Christoph Scheid, Renata Stripecke.
    Review: Sustainable Clinical Development of CAR-T Cells - Switching From Viral Transduction Towards CRISPR-Cas Gene Editing. Front Immunol 2022 Jun 17;13:865424. DOI https://doi.org/10.3389/fimmu.2022.865424.
    → open it on the web
  32. Jonas Kath, Weijie Du, Alina Pruene, Tobias Braun, Bernice Thommandru, Rolf Turk, Morgan L Sturgeon, Gavin L Kurgan, Leila Amini, Maik Stein, Tatiana Zittel, Stefania Martini, Lennard Ostendorf, Andreas Wilhelm, Levent Akyüz, Armin Rehm, Uta E Höpken, Axel Pruß, Annette Künkele, Ashley M Jacobi, Hans-Dieter Volk, Michael Schmueck-Henneresse, Renata Stripecke, Petra Reinke, Dimitrios L Wagner.
    Pharmacological interventions enhance virus-free generation of TRAC-replaced CAR T cells. Mol Ther Methods Clin Dev 2022 DOI https://doi.org/10.1016/j.omtm.2022.03.018.
    → open it on the web
  33. Maja Pizevska, Jaspal Kaeda, Enrico Fritsche, Hisham Elazaly, Petra Reinke, Leila Amini.
    Advanced Therapy Medicinal Products' Translation in Europe: A Developers' Perspective. Front Med (Lausanne) 2022 DOI https://doi.org/10.3389/fmed.2022.757647.
    → open it on the web
  34. Sybille Landwehr-Kenzel, Leonie Müller-Jensen, Joern-Sven Kuehl, Mohamed Abou-el-Enein, Henrike Hoffmann, Sandra Muench, Daniel Kaiser, Andy Roemhild, Horst von Bernuth, Mirjam Voeller, Michael Schmueck-Henneresse, Bernd Gruhn, Ulrik Stervbo, Nina Babel, Hans-Dieter Volk, and Petra Reinke.
    Adoptive transfer of ex vivo expanded regulatory T cells improves immune cell engraftment and therapy-refractory chronic GvHD. Mol Ther 2022 DOI https://doi.org/10.1016/j.ekir.2022.03.030.
    → open it on the web
  35. Amini L, Kaeda J, Fritsche E, Roemhild A, Kaiser D, Reinke P.
    Clinical adoptive regulatory T Cell therapy: State of the art, challenges, and prospective. Front Cell Dev Biol 2023 DOI https://doi.org/10.3389/fcell.2022.1081644.
    → open it on the web
  36. Tom Pieper, Kristian Daniel Ralph Roth, Viktor Glaser, Tobias Riet, Laura Elisa Buitrago-Molina, Maike Hagedorn, Maren Lieber, Michael Hust, Fatih Noyan, Elmar Jaeckel, Matthias Hardtke-Wolenski.
    Generation of Chimeric Antigen Receptors against Tetraspanin 7. Cells 2023 DOI https://doi.org/10.3390/cells12111453.
    → open it on the web
  37. Pierre Henschel, Sybille Landwehr-Kenzel , Niklas Engels, Andrea Schienke , Jakob Kremer, Tobias Riet , Nella Redel, Konstantinos Iordanidis , Valerie Saetzler , Katharina John, Miriam Heider, Matthias Hardtke-Wolenski , Heiner Wedemeyer, Elmar Jaeckel, Fatih Noyan.
    Supraphysiological FOXP3 expression in human CAR-Tregs results in improved stability, efficacy, and safety of CAR-Treg products for clinical application. J Autoimmun 2023 DOI https://doi.org/10.1016/j.jaut.2023.103057.
    → open it on the web
  38. Glaser V, Flugel C, Kath J, Du W, Drosdek V, Franke C, Stein M, Pruß A, Schmueck‐Henneresse M, Volk HD, Reinke P and Wagner DL.
    Combining different CRISPR nucleases for simultaneous knock-in and base editing prevents translocations in multiplex-edited CAR T cell. Genome Biology 2023 DOI https://doi.org/10.1186/s13059-023-02928-7.
    → open it on the web