Accelerating Development and Improving Access to CAR and TCR-engineered T cell therapy

Deliverables

A report for a series of campaigns including objectives, stakeholders, key messages, that details dissemination channels and metrics.

Regulatory advice

A report on the answers to the questions and advice from the regulator agencies for use in identifying unmet needs and determining how best to optimize models.

Publication Policy

A policy that defines a publication policy and process based upon the concept of a priori registration of planned publications including author determination.

Roadmap for addressing unmet needs and gaps in preclinical efficacy tools and models

A roadmap for model, and biomarker development for preclinical efficacy assessment of engineered T-cell therapies.

Working group for patients and Caregivers

A working group that will consist of 5 patients, 5 informal caregivers, and 5 patient organisation stakeholders.

Systematic review and manuscript on landscape of preclinical efficacy testing

A manuscript that summarizes the systematic review of the preclinical efficacy testing landscape

Project standardization process manuscript Committee of European National

A manuscript that describes the process of achieving standardization across the Committee of European National

RRI Charter

A 2-3 page charter based on the 6 RRI principles: 1) public engagement; 2) gender equality; 3) science education; 4) open access; 5) ethics; 6) governance.

Optimized preclinical efficacy models and tools

≥ 8 models that have been developed/optimized for preclinical efficacy assessment.

List of proposed standards to be developed, manuscript

A list of standards including a rationale for its choice based on the 4 criteria in task 5.3 and a plan for optimization and analytical validation.

Project Charter

A document that will explain the policies and procedures within the project as well as communication channels and expectations.

Roadmap for addressing unmet needs and gaps

A roadmap for model, and biomarker development for preclinical safety assessment of engineered T-cell therapies.

Manuscript on T-cell subpopulations and lymphodepletion regimens

Manuscript on T-cell subpopulation characterization and lymphodepletion regimens

Systematic review and manuscript on the landscape of preclinical safety testing

Systematic landscape review manuscript.

Standards technical committee

A standards technical committee that inlcudes experts in model and biomarker development as well as clinical experts.

Data management plan

A Data Management plan that includes details about the types of data in use, quality control, the data model, measures to protect privacy and security as well as data governance.

Regulatory advice on model development

A report on answers to the questions and advice from the regulatory agencies for use in identifying unmet needs and determining how best to optimize models.

Results dissemination campaign

A report including dissemination channels and metrics of the results dissemination campaign.

Manuscript on metanalysis of the effectiveness of T cell therapy after different lymphodepleting/conditioning regimens

Manuscript reporting the results of the metanalysis on the effectiveness of T-cell therapy after lymphodepletion.

Landscape of HCP information available

A report on the landscape of materials and information available to healthcare providers that will be used to update the EHA portal and inform the tools that will be developed.

E-learning platform for patients and caregivers

A co-created online modular hub (from basic information to more in-depth and disease/engineered T cell-specific information), that links to existing tools (MOOCs, animations, patient videos, doctor videos, fact sheets, infographics, knowledge base, treatment resources) that have been reviewed and curated. Information provision via various modalities (i.e. text or audio-visual) will allow for information giving tailored to patient characteristics such as specific information needs, education level, age (materials suitable for children) and cultural background. This e-learning hub will be hosted on the ECPC website.

Publications

Bendamustine is safe and effective for lymphodepletion before tisagenlecleucel in patients with refractory or relapsed large B-cell lymphomas

Author(s): Ghilardi G, Chong EA, Svoboda J, Wohlfarth P, Nasta SD, Williamson S, Landsburg JD, Gerson JN, Barta SK, Pajarillo R, Myers J, Chen AI, Schachter L, Yelton R, Ballard HJ, Hodges Dwinal A, Gier S, Victoriano D, Weber E, Napier E, Garfall A, Porter DL, Jäger U, Maziarz RT, Ruella M, Schuster SJ.
Published in: Ann Oncol, 2022, ISSN 2375-7965
Publisher: Austin Publishing Group
DOI: 10.1016/j.annonc.2022.05.521

Learning from the microbes: exploiting the microbiome to enforce T cell immunotherapy

Author(s): Sarah Staudt, Kai Ziegler-Martin, Alexander Visekruna, John Slingerland, Roni Shouval, Michael Hudecek, Marcel van den Brink, Maik Luu
Published in: Frontiers in Immunology, 2023, ISSN 1664-3224
Publisher: Frontiers
DOI: 10.3389/fimmu.2023.1269015

CAR Density Influences Antitumoral Efficacy of BCMA CAR T cells and Correlates with Clinical Outcome

Author(s): Rodriguez-Marquez P, Calleja-Cervantes ME, Serrano G, Oliver-Caldes A, Palacios-Berraquero ML, Martin-Mallo A, Calviño C, Español-Rego M, Ceballos C, Lozano T, San Martin-Uriz P, Vilas-Zornoza A, Rodriguez-Diaz S, Martinez-Turrillas R, Jauregui P, Alignani D, Viguria MC, Redondo M, Pascal M, Martin-Antonio B, Juan M, Urbano-Ispizua A, Rodriguez-Otero P, Alfonso-Pierola A, Paiva B, Lasarte JJ, In
Published in: Science Advances, 2022, ISSN 2375-2548
Publisher: American Association for the Advancement of Science
DOI: 10.1126/sciadv.abo0514

Targeting metabolic rewiring might decrease spread of tumor cells: Mitochondrial tRNA modifications promote cancer metastasis

Author(s): Maik Luu, Alexander Visekruna
Published in: Signal Transduction and Targeted Therapy, Issue Signal Transduction and Targeted Therapy (2022) 7:360, 2022, ISSN 2059-3635
Publisher: Nature
DOI: 10.1038/s41392-022-01205-6

CAR affinity modulates the sensitivity of CAR-T cells to PD-1/PD-L1-mediated inhibition

Author(s): Irene Andreu-Saumell, Alba Rodriguez-Garcia, Vanessa Mühlgrabner, Marta Gimenez-Alejandre, Berta Marzal, Joan Castellsagué, Fara Brasó-Maristany, Hugo Calderon, Laura Angelats, Salut Colell, Mara Nuding, Marta Soria-Castellano, Paula Barbao, Aleix Prat, Alvaro Urbano-Ispizua, Johannes B. Huppa, Sonia Guedan
Published in: Nature Communications, Issue 15, 2024, ISSN 2041-1723
Publisher: Nature Publishing Group
DOI: 10.1038/s41467-024-47799-z

Targeting the extra domain A of fibronectin for cancer therapy with CAR-T cells

Author(s): Celia Martín-Otal , Aritz Lasarte-Cia , Diego Serrano , Noelia Casares , Enrique Conde, Flor Navarro , Inés Sánchez-Moreno , Marta Gorraiz , Patricia Sarrión , Alfonso Calvo , Carlos E De Andrea, José Echeveste , Amaia Vilas , Juan Roberto Rodriguez-Madoz , Jesús San Miguel , Felipe Prosper , Sandra Hervas-Stubbs, Juan Jose Lasarte, Teresa Lozano
Published in: Journal for Immunotherapy of Cancer, 2023, ISSN 2051-1426
Publisher: BioMed Central, 2013
DOI: 10.1136/jitc-2021-004479

Chimeric antigen receptor T-cells targeting IL-1RAP: a promising new cellular immunotherapy to treat acute myeloid leukemia

Author(s): Trad R, Warda W, Alcazer V, Neto da Rocha M, Berceanu A, Nicod C, Haderbache R, Roussel X, Desbrosses Y, Daguindau E, Renosi F, Roumier C, Bouquet L, Biichle S, Guiot M, Seffar E, Caillot D, Depil S, Robinet E, Salma Y, Deconinck E, Deschamps M, Ferrand C.
Published in: Journal for Immunotherapy of Cancer, 2022, ISSN 2051-1426
Publisher: BMJ Journals
DOI: 10.1136/jitc-2021-004222

CD4 CAR-T cells targeting CD19 play a key role in exacerbating cytokine release syndrome, while maintaining long-term responses

Author(s): Camilla Bove 1, Silvia Arcangeli 1, Laura Falcone 1, Barbara Camisa 1 2, Rita El Khoury 1, Beatrice Greco 1, Anna De Lucia 1, Alice Bergamini 3, Attilio Bondanza 1, Fabio Ciceri 4 5, Chiara Bonini 2 5, Monica Casucci 6
Published in: Journal for Immunotherapy of Cancer, 2023, ISSN 2051-1426
Publisher: BioMed Central, 2013
DOI: 10.1136/jitc-2022-005878

Preclinical models for prediction of immunotherapy outcomes and immune evasion mechanisms in genetically heterogeneous multiple myeloma

Author(s): Marta Larrayoz, Maria J. Garcia-Barchino, Jon Celay, Amaia Etxebeste, Maddalen Jimenez, Cristina Perez, Raquel Ordoñez, Cesar Cobaleda, Cirino Botta, Vicente Fresquet, Sergio Roa, Ibai Goicoechea, Catarina Maia, Miren Lasaga, Marta Chesi, P. Leif Bergsagel, Maria J. Larrayoz, Maria J. Calasanz, Elena Campos-Sanchez, Jorge Martinez-Cano, Carlos Panizo, Paula Rodriguez-Otero, Silvestre Vicent, Giov
Published in: Nature Medicine, 2023, ISSN 0967-0912
Publisher: Institute of Materials
DOI: 10.1038/s41591-022-02178-3

mRNAs encoding IL-12 and a decoy-resistant variant of IL-18 synergize to engineer T cells for efficacious intratumoral adoptive immunotherapy

Author(s): Irene Olivera 1 , Elixabet Bolaños 1 , Jose Gonzalez-Gomariz 1 , Sandra Hervas-Stubbs 1 , Karina V Mariño 2 , Carlos Luri-Rey 1 , Iñaki Etxeberria 1 , Assunta Cirella 1 , Josune Egea 1 , Javier Glez-Vaz 1 , Saray Garasa 3 , Maite Alvarez 3 , Iñaki Eguren-Santamaria 1 , Sonia Guedan 4 , Miguel F Sanmamed 3 , Pedro Berraondo 3 , Gabriel A Rabinovich 5 , Alvaro Teijeira 1 , Igna
Published in: Cell Reports Medicine, 2023, ISSN 2666-3791
Publisher: ELSEVIER
DOI: 10.1016/j.xcrm.2023.100978

Lymphodepletion -An essential but undervalued part of the chimeric antigen receptor T-cell therapy cycle

Author(s): Benno Lickefett, Lulu Chu, Valentín Ortiz-Maldonado, Linda Warmuth, Pere Barba, Matteo Doglio, David Henderson, Michael Hudecek, Andreas Kremer, Janet Markman, Magdalena Nauerth, Helene Negre, Carmen Sanges, Philipp Staber, Rebecca Tanzi, Dirk Busch, Julio Delago, Jurgen Kuball, Maik Luu, Ulrich Jaeger
Published in: Frontiers in Immunology, 2023, ISSN 1664-3224
Publisher: Frontiers in Immunology
DOI: 10.3389/fimmu.2023.1303935

Safety and efficacy of tisagenlecleucel plus pembrolizumab in patients with r/r DLBCL: results from the phase Ib PORTIA study

Author(s): Ulrich Jaeger,1 Nina Worel,2 Joseph P. McGuirk,3 Peter A. Riedell,4 Isabelle Fleury,5 Yan, Du,6 Xia Han,7 David Pearson,8 Santiago Redondo,9 Edmund K. Waller10
Published in: Blood Advances, 2022, ISSN 2473-9537
Publisher: Elsevier Inc.
DOI: 10.1182/bloodadvances.2022007779

CAR Gene Delivery by T‐cell Targeted Lentiviral Vectors is Enhanced by Rapamycin Induced Reduction of Antiviral Mechanisms

Author(s): Filippos T Charitidis, Elham Adabi, Naphang Ho, Angela H Braun, Ciara Tierney, Lisa Strasser, Frederic B Thalheimer, Liam Childs, Jonathan Bones, Colin Clarke, Christian J Buchholz
Published in: Advanced Science, Issue 10, 2024, ISSN 2198-3844
Publisher: Advanced science
DOI: 10.1002/advs.202302992

CAR T cell manufacturing from naive/stem memory T lymphocytes enhances antitumor responses while curtailing cytokine release syndrome

Author(s): Silvia Arcangeli 1, Camilla Bove 1, Claudia Mezzanotte 1, Barbara Camisa 1 2, Laura Falcone 1, Francesco Manfredi 2, Eugenia Bezzecchi 3, Rita El Khoury 1, Rossana Norata 4, Francesca Sanvito 5, Maurilio Ponzoni 3 6, Beatrice Greco 1, Marta Angiola Moresco 1, Matteo G Carrabba 7, Fabio Ciceri 6 7, Chiara Bonini 2 6, Attilio Bondanza 1, Monica Casucci 1
Published in: Journal of Clinical Investigation, 2022, ISSN 0021-9738
Publisher: American Society for Clinical Investigation
DOI: 10.1172/jci150807

Accelerating development of engineered T cell therapies in the EU: current regulatory framework for studying multiple product versions and T2EVOLVE recommendations

Author(s): Delphine Ammar, Inga Schapitz, Maik Luu, Michael Hudecek, Miriam Meyer, Timmothy Taps, Bernd Schröder, Zoltán Ivics, Carmen Sanges, Paul Franz, Ulrike Koehl, Helene Negre, Inez Johanna, Jacquelyn Awigena-Cook
Published in: Frontiers in Immunology, 2023, ISSN 1664-3224
Publisher: Frontiers in Immunology
DOI: 10.3389/fimmu.2023.1280826

Upscaled CART-cells targeting IL-1RAP produced in a closed semi-automatic system, in GMP-like conditions, are ready for a first in man phase 1 clinical trial

Author(s): Clémentine Nicod and Mathieu Neto da Rocha Walid Warda,, Xavier Roussel,3, Rafik Haderbache, Evan Seffar, Rim Trad, Lucie Bouquet, Léa Bosdure, Marie-Charlotte Laude, Mélanie Guiot, Christophe Ferrand, and Marina Deschamps,
Published in: Current Research In translation medicine, 2022, ISSN 2452-3186
Publisher: Elsevier
DOI: 10.1016/j.retram.2023.103385

Time 2EVOLVE: predicting efficacy of engineered T-cells – how far is the bench from the bedside?

Author(s): Sonia Guedan, Maik Luu, Delphine Ammar, Paula Barbao, Chiara Bonini, Philippe Bousso, Christian J Buchholz, Monica Casucci, Biagio De Angelis, Emmanuel Donnadieu, David Espie, Beatrice Greco, Richard Groen, Johannes B Huppa, Chahrazade Kantari-Mimoun, Bruno Laugel, Mary Mantock, Janet L Markman, Emma Morris, Concetta Quintarelli, Michael Rade, Kristin Reiche, Alba Rodriguez-Garcia, Juan Roberto Ro
Published in: Journal for Immunotherapy of Cancer, Issue """J Immunother Cancer . 2022 May;10(5):e003487""", 2022, ISSN 2051-1426
Publisher: BMJ Journals
DOI: 10.1136/jitc-2021-003487

Overcoming T cell dysfunction in acidic pH to enhance adoptive T cell transfer immunotherapy

Author(s): Flor Navarro a, Noelia Casares a, Celia Martín-Otal a, Aritz Lasarte-Cía a, Marta Gorraiza, Patricia Sarrión a, Diana Llopiza, David Reparaz a, Nerea Varo b, Juan Roberto Rodriguez-Madoz c, Felipe Prosper c,d, Sandra Hervás-Stubbs a, Teresa Lozano a*, and Juan José Lasarte a*
Published in: ONCOIMMUNOLOGY, 2022, ISSN 2162-4011
Publisher: Landes Bioscience
DOI: 10.1080/2162402x.2022.2070337

Time to evolve: predicting engineered T cell-associated toxicity with next-generation models

Author(s): Emmanuel Donnadieu, Maik Luu, Miriam Alb, Brigitte Anliker, Silvia Arcangeli, Chiara Bonini, Biagio De Angelis, Rashmi Choudhary, David Espie, Anne Galy, Cam Holland Zoltán Ivics, Chahrazade Kantari-Mimoun, Marie Jose Kersten, Ulrike Köhl, Chantal Kuhn, Bruno Laugel, Franco Locatelli, Ibtissam Marchiq, Janet Markman, Marta Angiola Moresco, Emma Morris, Helene Negre, Concet
Published in: Journal for Immunotherapy of Cancer, Issue """J Immunother Cancer . 2022 May;10(5):e003486.""", 2022, ISSN 2051-1426
Publisher: BMJ Journals
DOI: 10.1136/jitc-2021-003486

Development of a Core Set of Patient- and Caregiver-Reported Signs and Symptoms to Facilitate Early Recognition of Acute Chimeric Antigen Receptor T-Cell Therapy Toxicities

Author(s): Anne M. Spanjaart*, Elise R.A. Pennings*, Milan Kos, Pim G.N.J. Mutsaers, Pieternella J. Lugtenburg, Tom van Meerten, Jaap A. van Doesum, Monique C. Minnema, Margot Jak, Suzanne van Dorp, Joost S.P. Vermaat, Marjolein W.M. van der Poel, Martijn G.H. van Oijen, Maria T. Kuipers, Inger S. Nijhof, Marie Jose Kersten
Published in: JCO Oncology Practice, 2023, ISSN 2688-1535
Publisher: American Society of Clinical Oncolog
DOI: 10.1200/op.22.00501

Droplet digital PCR allows vector copy number assessment and monitoring of experimental CAR T cells in murine xenograft models or approved CD19 CAR T cell-treated patients

Author(s): Haderbache R, Warda W, Hervouet E, da Rocha MN, Trad R, Allain V, Nicod C, Thieblemeont C, Boissel N, Varlet P, Agha IY, Bouquet L, Guiot M, Venet F, Sujobert P, Roussel X, Rouzaire PO, Caillot D, Casasnovas O, Bories JC, Bachy E, Caillat-Zucman S, Deschamps M, Ferrand C.
Published in: J Transl Med, 2021, ISSN 1479-5876
Publisher: BioMed Central
DOI: 10.1186/s12967-021-02925-z

Immunotherapy: ACCELERATING DEVELOPMENT AND IMPROVING ACCESS TO CAR- AND TCR-ENGINEERED T CELL THERAPY IN EUROPE

Author(s): Maik Luu, Carmen Sanges, Aleksandra Draper, Ninja Hoen, Sapna Sheth, Scott Wagers, Helene Negre, Michael Hudecek
Published in: Cythotherapy, Issue May 2022Cytotherapy 24(5):S130, 2022
Publisher: Elsevier
DOI: 10.1016/s1465-3249(22)00349-8

Development of optimal lymphodepletion/conditioning regimens – Work Package 6 of the T2EVOLVE Project

Author(s): Dirk Busch1, Janet Markman2, Andreas Kremer3, David Henderson4, Linda Warmuth1, Benno Lickefett5, Eleonora Friedberg5, Johannes Huppa5, Maik Luu6, Kristin Reiche7, Hélène Nègre8, Carmen Sanges6, Michael Hudecek6, Ulrich Jaeger5 for the members of WP6
Published in: 2023
Publisher: EBMT-EHA/CART2023

Deliverables

Publications

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