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3. Targeting TGFβ-activated kinase-1 activation in microglia reduces CAR T immune effector cell-associated neurotoxicity syndrome

Author

Vinnakota, Janaki Manoja, Biavasco, Francesca, Schwabenland, Marius, Chhatbar, Chintan, Adams, Rachael C., Erny, Daniel, Duquesne, Sandra, El Khawanky, Nadia, Schmidt, Dominik, Fetsch, Viktor, Zähringer, Alexander, Salié, Henrike, Athanassopoulos, Dimitrios, Braun, Lukas M., Javorniczky, Nora R., Ho, Jenny N. H. G., Kierdorf, Katrin, Marks, Reinhard, Wäsch, Ralph, Simonetta, Federico, Andrieux, Geoffroy, Pfeifer, Dietmar, Monaco, Gianni, Capitini, Christian, Fry, Terry J., Blank, Thomas, Blazar, Bruce R., Wagner, Eva, Theobald, Matthias, Sommer, Clemens, Stelljes, Matthias, Reicherts, Christian, Jeibmann, Astrid, Schittenhelm, Jens, Monoranu, Camelia-Maria, Rosenwald, Andreas, Kortüm, Martin, Rasche, Leo, Einsele, Hermann, Meyer, Philipp T., Brumberg, Joachim, Völkl, Simon, Mackensen, Andreas, Coras, Roland, von Bergwelt-Baildon, Michael, Albert, Nathalie L., Bartos, Laura M., Brendel, Matthias, Holzgreve, Adrien, Mack, Matthias, Boerries, Melanie, Mackall, Crystal L., Duyster, Justus, Henneke, Philipp, Priller, Josef, Köhler, Natalie, Strübing, Felix, Bengsch, Bertram, Ruella, Marco, Subklewe, Marion, von Baumgarten, Louisa, Gill, Saar, Prinz, Marco, and Zeiser, Robert

Published
2024
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5. A Web- and App-Based Connected Care Solution for COVID-19 In- and Outpatient Care: Qualitative Study and Application Development

Author

Schinköthe, Timo, Gabri, Mariano Rolando, Mitterer, Manfred, Gouveia, Pedro, Heinemann, Volker, Harbeck, Nadia, and Subklewe, Marion

Subjects
Public aspects of medicine, RA1-1270
Abstract

BackgroundFrom the perspective of health care professionals, coronavirus disease (COVID-19) brings many challenges as well as opportunities for digital health care. One challenge is that health care professionals are at high risk of infection themselves. Therefore, in-person visits need to be reduced to an absolute minimum. Connected care solutions, including telehealth, remote patient monitoring, and secure communications between clinicians and their patients, may rapidly become the first choice in such public health emergencies. ObjectiveThe aim of the COVID-19 Caregiver Cockpit (C19CC) was to implement a free-of-charge, web- and app-based tool for patient assessment to assist health care professionals working in the COVID-19 environment. MethodsPhysicians in Argentina, Germany, Iran, Italy, Portugal, Switzerland, and the United States explained their challenges with COVID-19 patient care through unstructured interviews. Based on the collected feedback, the first version of the C19CC was built. In the second round of interviews, the application was presented to physicians, and more feedback was obtained. ResultsPhysicians identified a number of different scenarios where telemedicine or connected care solutions could rapidly improve patient care. These scenarios included outpatient care, discharge management, remote tracking of patients with chronic diseases, as well as incorporating infected physicians under quarantine into telehealth services. ConclusionsThe C19CC is the result of an agile and iterative development process that complements the work of physicians. It aims to improve the care and safety of people who are infected by COVID-19.

Published
2020
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6. Characterization of cognitive symptoms in post COVID-19 patients

Author

Ruzicka, Michael, Sachenbacher, Simone, Heimkes, Fides, Uebleis, Aline Olivia, Karch, Susanne, Grosse-Wentrup, Fabienne, Ibarra Fonseca, Gerardo Jesus, Wunderlich, Nora, Bogner, Johannes, Mayerle, Julia, von Bergwelt-Baildon, Michael, Falkai, Peter, Subklewe, Marion, Ruzicka, Thomas, Benesch, Christopher, Valdinoci, Elisabeth, Pernpruner, Anna, Thomas, Anabel, Heindl, Bernhard, Stubbe, Hans Christian, and Adorjan, Kristina

Published
2024
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7. Multicenter development of a PET-based risk assessment tool for product-specific outcome prediction in large B-cell lymphoma patients undergoing CAR T-cell therapy

Author

Voltin, Conrad-Amadeus, Paccagnella, Andrea, Winkelmann, Michael, Heger, Jan-Michel, Casadei, Beatrice, Beckmann, Laura, Herrmann, Ken, Dekorsy, Franziska J., Kutsch, Nadine, Borchmann, Peter, Fanti, Stefano, Kunz, Wolfgang G., Subklewe, Marion, Kobe, Carsten, Zinzani, Pier Luigi, Stelljes, Matthias, Roth, Katrin S., Drzezga, Alexander, Noppeney, Richard, Rahbar, Kambiz, Reinhardt, H. Christian, von Tresckow, Bastian, Seifert, Robert, Albring, Jörn C., Blumenberg, Viktoria, Farolfi, Andrea, Flossdorf, Sarah, Gödel, Philipp, and Hanoun, Christine

Published
2024
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8. Impact of prior therapies and subsequent transplantation on outcomes in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia treated with brexucabtagene autoleucel in ZUMA-3.

Author

Shah, Bijal, Cassaday, Ryan, Park, Jae, Houot, Roch, Oluwole, Olalekan, Logan, Aaron, Boissel, Nicolas, Leguay, Thibaut, Bishop, Michael, Topp, Max, Mao, Daqin, Adhikary, Sabina, Zhou, Lang, Schuberth, Petra, Damico Khalid, Rita, Ghobadia, Armin, ODwyer, Kristen, Arellano, Martha, Lin, Yi, Baer, Maria, Subklewe, Marion, Abedi, Mehrdad, Minnema, Monique, Wierda, William, DeAngelo, Daniel, Stiff, Patrick, Schiller, Gary, Jeyakumar, Deepa, and Tzachanis, Dimitrios

Subjects
Cell Engineering, Cytotoxicity, Immunologic, Hematologic Neoplasms, Immunity, Cellular, Immunotherapy, Humans, Adult, Immunotherapy, Adoptive, Hematopoietic Stem Cell Transplantation, Adaptor Proteins, Signal Transducing, Antigens, CD19, Cytokine Release Syndrome, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Abstract

BACKGROUND: Brexucabtagene autoleucel (brexu-cel) is an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy approved in the USA for adults with relapsed or refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL) and in the European Union for patients ≥26 years with R/R B-ALL. After 2 years of follow-up in ZUMA-3, the overall complete remission (CR) rate (CR+CR with incomplete hematological recovery (CRi)) was 73%, and the median overall survival (OS) was 25.4 months in 78 Phase 1 and 2 patients with R/R B-ALL who received the pivotal dose of brexu-cel. Outcomes by prior therapies and subsequent allogeneic stem cell transplantation (alloSCT) are reported. METHODS: Eligible adults had R/R B-ALL and received one infusion of brexu-cel (1×10⁶ CAR T cells/kg) following conditioning chemotherapy. The primary endpoint was the CR/CRi rate per central review. Post hoc subgroup analyses were exploratory with descriptive statistics provided. RESULTS: Phase 1 and 2 patients (N=78) were included with median follow-up of 29.7 months (range, 20.7-58.3). High CR/CRi rates were observed across all prior therapy subgroups examined: 1 prior line of therapy (87%, n=15) and ≥2 prior lines (70%, n=63); prior blinatumomab (63%, n=38) and no prior blinatumomab (83%, n=40); prior inotuzumab (59%, n=17) and no prior inotuzumab (77%, n=61); and prior alloSCT (76%, n=29) and no prior alloSCT (71%, n=49). The frequency of Grade ≥3 cytokine release syndrome, neurological events, and treatment-related Grade 5 adverse events were largely similar among prior therapy subgroups.Median duration of remission (DOR) in responders with (n=14) and without (n=43) subsequent alloSCT was 44.2 (95% CI, 8.1 to not estimable (NE)) and 18.6 months (95% CI, 9.4 to NE); median OS was 47.0 months (95% CI, 10.2 to NE) and not reached (95% CI, 23.2 to NE), respectively. Median DOR and OS were not reached in responders without prior or subsequent alloSCT (n=22). CONCLUSIONS: In ZUMA-3, adults with R/R B-ALL benefited from brexu-cel, regardless of prior therapies and subsequent alloSCT status, though survival appeared better in patients without certain prior therapies and in earlier lines of therapy. Additional studies are needed to determine the impact prior therapies and subsequent alloSCT have on outcomes of patients who receive brexu-cel.

Published
2023

9. Novel prognostic scoring systems for severe CRS and ICANS after anti-CD19 CAR T cells in large B-cell lymphoma

Author

Sesques, Pierre, Kirkwood, Amy A., Kwon, Mi, Rejeski, Kai, Jain, Michael D., Di Blasi, Roberta, Brisou, Gabriel, Gros, François-Xavier, le Bras, Fabien, Bories, Pierre, Choquet, Sylvain, Rubio, Marie-Thérèse, Iacoboni, Gloria, O’Reilly, Maeve, Casasnovas, René-Olivier, Bay, Jacques-Olivier, Mohty, Mohamad, Joris, Magalie, Abraham, Julie, Castilla Llorente, Cristina, Loschi, Mickael, Carras, Sylvain, Chauchet, Adrien, La Rochelle, Laurianne Drieu, Hermine, Olivier, Guidez, Stéphanie, Cony-Makhoul, Pascale, Fogarty, Patrick, Le Gouill, Steven, Morschhauser, Franck, Gastinne, Thomas, Cartron, Guillaume, Subklewe, Marion, Locke, Frederick L., Sanderson, Robin, Barba, Pere, Houot, Roch, and Bachy, Emmanuel

Published
2024
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11. Combining venetoclax and azacytidine with T-cell bispecific antibodies for treatment of acute myeloid leukemia: a preclinical assessment

Author

Hänel, Gerulf, Schönle, Anne, Neumann, Anne-Sophie, Nixdorf, Daniel, Philipp, Nora, Sponheimer, Monika, Leutbecher, Alexandra, Emhardt, Alica-Joana, Magno, Giulia, Bücklein, Veit, Eckmann, Jan, Dunshee, Diana, Kramar, Vesna, Korfi, Koorosh, Colombetti, Sara, Umaña, Pablo, Klein, Christian, and Subklewe, Marion

Published
2024
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12. Sex-associated differences in frequencies and prognostic impact of recurrent genetic alterations in adult acute myeloid leukemia (Alliance, AMLCG)

Author

Ozga, Michael, Nicolet, Deedra, Mrózek, Krzysztof, Yilmaz, Ayse S., Kohlschmidt, Jessica, Larkin, Karilyn T., Blachly, James S., Oakes, Christopher C., Buss, Jill, Walker, Christopher J., Orwick, Shelley, Jurinovic, Vindi, Rothenberg-Thurley, Maja, Dufour, Annika, Schneider, Stephanie, Sauerland, Maria Cristina, Görlich, Dennis, Krug, Utz, Berdel, Wolfgang E., Woermann, Bernhard J., Hiddemann, Wolfgang, Braess, Jan, Subklewe, Marion, Spiekermann, Karsten, Carroll, Andrew J., Blum, William G., Powell, Bayard L., Kolitz, Jonathan E., Moore, Joseph O., Mayer, Robert J., Larson, Richard A., Uy, Geoffrey L., Stock, Wendy, Metzeler, Klaus H., Grimes, H. Leighton, Byrd, John C., Salomonis, Nathan, Herold, Tobias, Mims, Alice S., and Eisfeld, Ann-Kathrin

Published
2024
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15. Substantial differences in perception of disease severity between post COVID-19 patients, internists, and psychiatrists or psychologists: the Health Perception Gap and its clinical implications

Author

Ruzicka, Michael, Ibarra Fonseca, Gerardo Jesus, Sachenbacher, Simone, Heimkes, Fides, Grosse-Wentrup, Fabienne, Wunderlich, Nora, Benesch, Christopher, Pernpruner, Anna, Valdinoci, Elisabeth, Rueb, Mike, Uebleis, Aline Olivia, Karch, Susanne, Bogner, Johannes, Mayerle, Julia, von Bergwelt-Baildon, Michael, Subklewe, Marion, Heindl, Bernhard, Stubbe, Hans Christian, and Adorjan, Kristina

Published
2023
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16. Single-cell transcriptomic atlas-guided development of CAR-T cells for the treatment of acute myeloid leukemia

Author

Gottschlich, Adrian, Thomas, Moritz, Grünmeier, Ruth, Lesch, Stefanie, Rohrbacher, Lisa, Igl, Veronika, Briukhovetska, Daria, Benmebarek, Mohamed-Reda, Vick, Binje, Dede, Sertac, Müller, Katharina, Xu, Tao, Dhoqina, Dario, Märkl, Florian, Robinson, Sophie, Sendelhofert, Andrea, Schulz, Heiko, Umut, Öykü, Kavaka, Vladyslav, Tsiverioti, Christina Angeliki, Carlini, Emanuele, Nandi, Sayantan, Strzalkowski, Thaddäus, Lorenzini, Theo, Stock, Sophia, Müller, Philipp Jie, Dörr, Janina, Seifert, Matthias, Cadilha, Bruno L., Brabenec, Ruben, Röder, Natalie, Rataj, Felicitas, Nüesch, Manuel, Modemann, Franziska, Wellbrock, Jasmin, Fiedler, Walter, Kellner, Christian, Beltrán, Eduardo, Herold, Tobias, Paquet, Dominik, Jeremias, Irmela, von Baumgarten, Louisa, Endres, Stefan, Subklewe, Marion, Marr, Carsten, and Kobold, Sebastian

Published
2023
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18. CD33 BiTE® molecule-mediated immune synapse formation and subsequent T-cell activation is determined by the expression profile of activating and inhibitory checkpoint molecules on AML cells

Author

Marcinek, Anetta, Brauchle, Bettina, Rohrbacher, Lisa, Hänel, Gerulf, Philipp, Nora, Märkl, Florian, Strzalkowski, Thaddäus, Lacher, Sonja M., Udiljak, Dragica, Spiekermann, Karsten, Theurich, Sebastian, Kobold, Sebastian, Kischel, Roman, James, John R., Bücklein, Veit L., and Subklewe, Marion

Published
2023
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22. The CAR-HEMATOTOX score as a prognostic model of toxicity and response in patients receiving BCMA-directed CAR-T for relapsed/refractory multiple myeloma

Author

Rejeski, Kai, Hansen, Doris K., Bansal, Radhika, Sesques, Pierre, Ailawadhi, Sikander, Logue, Jennifer M., Bräunlein, Eva, Cordas dos Santos, David M., Freeman, Ciara L., Alsina, Melissa, Theurich, Sebastian, Wang, Yucai, Krackhardt, Angela M., Locke, Frederick L., Bachy, Emmanuel, Jain, Michael D., Lin, Yi, and Subklewe, Marion

Published
2023
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24. Two-year follow-up of KTE-X19 in patients with relapsed or refractory adult B-cell acute lymphoblastic leukemia in ZUMA-3 and its contextualization with SCHOLAR-3, an external historical control study

Author

Shah, Bijal D, Ghobadi, Armin, Oluwole, Olalekan O, Logan, Aaron C, Boissel, Nicolas, Cassaday, Ryan D, Leguay, Thibaut, Bishop, Michael R, Topp, Max S, Tzachanis, Dimitrios, O’Dwyer, Kristen M, Arellano, Martha L, Lin, Yi, Baer, Maria R, Schiller, Gary J, Park, Jae H, Subklewe, Marion, Abedi, Mehrdad, Minnema, Monique C, Wierda, William G, DeAngelo, Daniel J, Stiff, Patrick, Jeyakumar, Deepa, Dong, Jinghui, Adhikary, Sabina, Zhou, Lang, Schuberth, Petra C, Faghmous, Imi, Masouleh, Behzad Kharabi, and Houot, Roch

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Clinical Research, Rare Diseases, Pediatric Cancer, Stem Cell Research, Hematology, Pediatric Research Initiative, Clinical Trials and Supportive Activities, Childhood Leukemia, Cancer, Pediatric, Humans, Adult, Immunotherapy, Adoptive, Retrospective Studies, Historically Controlled Study, Recurrence, Receptors, Chimeric Antigen, Antigens, CD19, Precursor Cell Lymphoblastic Leukemia-Lymphoma, B-precursor acute lymphoblastic leukemia, Brexucabtagene autoleucel, CAR T-cell therapy, KTE-X19, SCHOLAR-3, ZUMA-3, Cardiorespiratory Medicine and Haematology, Cardiovascular medicine and haematology, Oncology and carcinogenesis
Abstract

BackgroundBrexucabtagene autoleucel (KTE-X19) is an autologous anti-CD19 CAR T-cell therapy approved in the USA to treat adult patients with relapsed or refractory B-precursor acute lymphoblastic leukemia (R/R B-ALL) based on ZUMA-3 study results. We report updated ZUMA-3 outcomes with longer follow-up and an extended data set along with contextualization of outcomes to historical standard of care.MethodsAdults with R/R B-ALL received a single infusion of KTE-X19 (1 × 106 CAR T cells/kg). Long-term post hoc subgroup assessments of ZUMA-3 were conducted. Outcomes from matched patients between historical clinical trials and ZUMA-3 patients were assessed in the retrospective historical control study SCHOLAR-3.ResultsAfter 26.8-months median follow-up, the overall complete remission (CR) rate (CR + CR with incomplete hematological recovery) among treated patients (N = 55) in phase 2 was 71% (56% CR rate); medians for duration of remission and overall survival (OS) were 14.6 and 25.4 months, respectively. Most patients responded to KTE-X19 regardless of age or baseline bone marrow blast percentage, but less so in patients with > 75% blasts. No new safety signals were observed. Similar outcomes were observed in a pooled analysis of phase 1 and 2 patients (N = 78). In SCHOLAR-3, the median OS for treated patients from ZUMA-3 (N = 49) and matched historical controls (N = 40) was 25.4 and 5.5 months, respectively.ConclusionsThese data, representing the longest follow-up of CAR T-cell therapy in a multicenter study of adult R/R B-ALL, suggest that KTE-X19 provides a clinically meaningful survival benefit with manageable toxicity in this population.Trial registrationNCT02614066.

Published
2022

25. A non-antibiotic-disrupted gut microbiome is associated with clinical responses to CD19-CAR-T cell cancer immunotherapy

Author

Stein-Thoeringer, Christoph K., Saini, Neeraj Y., Zamir, Eli, Blumenberg, Viktoria, Schubert, Maria-Luisa, Mor, Uria, Fante, Matthias A., Schmidt, Sabine, Hayase, Eiko, Hayase, Tomo, Rohrbach, Roman, Chang, Chia-Chi, McDaniel, Lauren, Flores, Ivonne, Gaiser, Rogier, Edinger, Matthias, Wolff, Daniel, Heidenreich, Martin, Strati, Paolo, Nair, Ranjit, Chihara, Dai, Fayad, Luis E., Ahmed, Sairah, Iyer, Swaminathan P., Steiner, Raphael E., Jain, Preetesh, Nastoupil, Loretta J., Westin, Jason, Arora, Reetakshi, Wang, Michael L., Turner, Joel, Menges, Meghan, Hidalgo-Vargas, Melanie, Reid, Kayla, Dreger, Peter, Schmitt, Anita, Müller-Tidow, Carsten, Locke, Frederick L., Davila, Marco L., Champlin, Richard E., Flowers, Christopher R., Shpall, Elizabeth J., Poeck, Hendrik, Neelapu, Sattva S., Schmitt, Michael, Subklewe, Marion, Jain, Michael D., Jenq, Robert R., and Elinav, Eran

Published
2023
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27. The side effect registry immuno-oncology (SERIO) – A tool for systematic analysis of immunotherapy-induced side effects

Author

Ertl, Carolin, Ruf, Theresa, Mentzer, Dirk, Kong, Mingzi, Kramer, Rafaela, Bergwelt-Baildon, Michael von, Subklewe, Marion, Tomsitz, Dirk, Ascierto, Paolo A., Dummer, Reinhard, Gogas, Helen, Lebbé, Celeste, Long, Georgina V., McArthur, Grant, Neilan, Tomas G., Ribas, Antoni, Robert, Caroline, Schadendorf, Dirk, Zimmer, Lisa, Eigentler, Thomas, Grabbe, Stephan, Forschner, Andrea, Kähler, Katharina C., Milani, Valeria, Pföhler, Claudia, Hassel, Jessica, Gutzmer, Ralf, Loquai, Carmen, Routy, Bertrand, Furness, Andrew J.S., Blank, Christian, Wolchok, Jedd D., French, Lars E., Hauschild, Axel, and Heinzerling, Lucie

Published
2024
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28. Impact of age on outcome of CAR-T cell therapies for large B-cell lymphoma: the GLA/DRST experience

Author

Dreger, Peter, Holtick, Udo, Subklewe, Marion, von Tresckow, Bastian, Ayuk, Francis, Wagner, Eva, Wulf, Gerald, Marks, Reinhardt, Penack, Olaf, Schnetzke, Ulf, Koenecke, Christian, von Bonin, Malte, Stelljes, Matthias, Glass, Bertram, Baldus, Claudia D., Vucinic, Vladan, Mougiakakos, Dimitrios, Topp, Max, Schroers, Roland, Wolff, Daniel, Thomas, Simone, Kröger, Nicolaus, and Bethge, Wolfgang A.

Published
2023
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32. Standardising acute myeloid leukaemia classification systems: a perspective from a panel of international experts

Author

Shallis, Rory M, Daver, Naval, Altman, Jessica K, Komrokji, Rami S, Pollyea, Daniel A, Badar, Talha, Bewersdorf, Jan P, Bhatt, Vijaya R, de Botton, Stéphane, de la Fuente Burguera, Adolfo, Carraway, Hetty E, Desai, Pinkal, Dillon, Richard, Duployez, Nicolas, El Chaer, Firas, Fathi, Amir T, Freeman, Sylvie D, Gojo, Ivana, Grunwald, Michael R, Jonas, Brian A, Konopleva, Marina, Lin, Tara L, Mannis, Gabriel N, Mascarenhas, John, Michaelis, Laura C, Mims, Alice S, Montesinos, Pau, Pozdnyakova, Olga, Pratz, Keith W, Schuh, Andre C, Sekeres, Mikkael A, Smith, Catherine C, Stahl, Maximilian, Subklewe, Marion, Uy, Geoffrey L, Voso, Maria Teresa, Walter, Roland B, Wang, Eunice S, Zeidner, Joshua F, Žučenka, Andrius, and Zeidan, Amer M

Published
2023
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33. Correction to: CD33 BiTE® molecule-mediated immune synapse formation and subsequent T-cell activation is determined by the expression profile of activating and inhibitory checkpoint molecules on AML cells

Author

Marcinek, Anetta, Brauchle, Bettina, Rohrbacher, Lisa, Hänel, Gerulf, Philipp, Nora, Märkl, Florian, Strzalkowski, Thaddäus, Lacher, Sonja M., Udiljak, Dragica, Spiekermann, Karsten, Theurich, Sebastian, Kobold, Sebastian, Kischel, Roman, James, John R., Bücklein, Veit L., and Subklewe, Marion

Published
2023
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35. Targeting FLT3 with a new-generation antibody-drug conjugate in combination with kinase inhibitors for treatment of AML

Author

Roas, Maike, Vick, Binje, Kasper, Marc-André, Able, Marina, Polzer, Harald, Gerlach, Marcus, Kremmer, Elisabeth, Hecker, Judith S., Schmitt, Saskia, Stengl, Andreas, Waller, Verena, Hohmann, Natascha, Festini, Moreno, Ludwig, Alexander, Rohrbacher, Lisa, Herold, Tobias, Subklewe, Marion, Götze, Katharina S., Hackenberger, Christian P. R., Schumacher, Dominik, Helma-Smets, Jonas, Jeremias, Irmela, Leonhardt, Heinrich, and Spiekermann, Karsten

Published
2023
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36. Potential synergy between radiotherapy and CAR T-cells - a multicentric analysis of the role of radiotherapy in the combination of CAR T cell therapy

Author

Fan, Jiaqi, Adams, Anne, Sieg, Noëlle, Heger, Jan-Michel, Gödel, Philipp, Kutsch, Nadine, Kaul, David, Teichert, Marcel, von Tresckow, Bastian, Bücklein, Veit, Goesmann, Gretha, Li, Minglun, Struve, Nathalie, Trommer, Maike, Linde, Philipp, Rosenbrock, Johannes, Celik, Eren, Penack, Olaf, Stuschke, Martin, Subklewe, Marion, Belka, Claus, von Bergwelt-Baildon, Michael, Borchmann, Peter, Marnitz, Simone, and Baues, Christian

Published
2023
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38. Liver-FDG-uptake and CAR T-cell kinetics augment early PET/CT prognostic value for CD19-targeted CAR T-cell therapy in diffuse large B cell lymphoma

Author

Beck, Michael, primary, Blumenberg, Viktoria, additional, Bücklein, Veit, additional, Bundschuh, Ralph, additional, Harrer, Dennis, additional, Hirschbühl, Klaus, additional, Jung, Johannes, additional, Kunz, Wolfgang, additional, Menhart, Karin, additional, Winkelmann, Michael, additional, Yakushev, Igor, additional, Illert, Anna Lena, additional, Eckstein, Markus, additional, Völkl, Simon, additional, Claus, Rainer, additional, Hansmann, Leo, additional, Hecker, Judith, additional, Kuwert, Torsten, additional, Mackensen, Andreas, additional, Subklewe, Marion, additional, Hellwig, Dirk, additional, and Müller, Fabian, additional

Published
2024
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39. Safety and tolerability of AMG 330 in adults with relapsed/refractory AML: a phase 1a dose-escalation study

Author

Ravandi, Farhad, primary, Subklewe, Marion, additional, Walter, Roland B., additional, Vachhani, Pankit, additional, Ossenkoppele, Gert, additional, Buecklein, Veit, additional, Döhner, Hartmut, additional, Jongen-Lavrencic, Mojca, additional, Baldus, Claudia D., additional, Fransecky, Lars, additional, Pardee, Timothy S., additional, Kantarjian, Hagop, additional, Yen, Priscilla K., additional, Mukundan, Lata, additional, Panwar, Bharat, additional, Yago, Marc R., additional, Agarwal, Suresh, additional, Khaldoyanidi, Sophia K., additional, and Stein, Anthony, additional

Published
2024
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42. A polyamine-centric, blood-based metabolite panel predictive of poor response to CAR-T cell therapy in large B cell lymphoma

Author

Fahrmann, Johannes F., Saini, Neeraj Y., Chia-Chi, Chang, Irajizad, Ehsan, Strati, Paolo, Nair, Ranjit, Fayad, Luis E., Ahmed, Sairah, Lee, Hun Ju, Iyer, Swaminathan, Steiner, Raphael, Vykoukal, Jody, Wu, Ranran, Dennison, Jennifer B., Nastoupil, Loretta, Jain, Preetesh, Wang, Michael, Green, Michael, Westin, Jason, Blumenberg, Viktoria, Davila, Marco, Champlin, Richard, Shpall, Elizabeth J., Kebriaei, Partow, Flowers, Christopher R., Jain, Michael, Jenq, Robert, Stein-Thoeringer, Christoph K., Subklewe, Marion, Neelapu, Sattva S., and Hanash, Sam

Published
2022
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43. T-cell exhaustion induced by continuous bispecific molecule exposure is ameliorated by treatment-free intervals

Author

Philipp, Nora, Kazerani, Maryam, Nicholls, Alyssa, Vick, Binje, Wulf, Jan, Straub, Tobias, Scheurer, Michaela, Muth, Amelie, Hänel, Gerulf, Nixdorf, Daniel, Sponheimer, Monika, Ohlmeyer, Malte, Lacher, Sonja M., Brauchle, Bettina, Marcinek, Anetta, Rohrbacher, Lisa, Leutbecher, Alexandra, Rejeski, Kai, Weigert, Oliver, von Bergwelt-Baildon, Michael, Theurich, Sebastian, Kischel, Roman, Jeremias, Irmela, Bücklein, Veit, and Subklewe, Marion

Published
2022
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44. GLA/DRST real-world outcome analysis of CAR T-cell therapies for large B-cell lymphoma in Germany

Author

Bethge, Wolfgang A., Martus, Peter, Schmitt, Michael, Holtick, Udo, Subklewe, Marion, von Tresckow, Bastian, Ayuk, Francis, Wagner-Drouet, Eva Marie, Wulf, Gerald G., Marks, Reinhard, Penack, Olaf, Schnetzke, Ulf, Koenecke, Christian, von Bonin, Malte, Stelljes, Matthias, Glass, Bertram, Baldus, Claudia D., Vucinic, Vladan, Mougiakakos, Dimitrios, Topp, Max, Fante, Matthias A., Schroers, Roland, Bayir, Lale, Borchmann, Peter, Buecklein, Veit, Hasenkamp, Justin, Hanoun, Christine, Thomas, Simone, Beelen, Dietrich W., Lengerke, Claudia, Kroeger, Nicolaus, and Dreger, Peter

Published
2022
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48. Accumulation of mutations in antibody and CD8 T cell epitopes in a B cell depleted lymphoma patient with chronic SARS-CoV-2 infection

Author

Khatamzas, Elham, Antwerpen, Markus H., Rehn, Alexandra, Graf, Alexander, Hellmuth, Johannes Christian, Hollaus, Alexandra, Mohr, Anne-Wiebe, Gaitzsch, Erik, Weiglein, Tobias, Georgi, Enrico, Scherer, Clemens, Stecher, Stephanie-Susanne, Gruetzner, Stefanie, Blum, Helmut, Krebs, Stefan, Reischer, Anna, Leutbecher, Alexandra, Subklewe, Marion, Dick, Andrea, Zange, Sabine, Girl, Philipp, Müller, Katharina, Weigert, Oliver, Hopfner, Karl-Peter, Stemmler, Hans-Joachim, von Bergwelt-Baildon, Michael, Keppler, Oliver T., Wölfel, Roman, Muenchhoff, Maximilian, and Moosmann, Andreas

Published
2022
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49. Recent Bendamustine Treatment Before Apheresis Has a Negative Impact on Outcomes in Patients With Large B-Cell Lymphoma Receiving Chimeric Antigen Receptor T-Cell Therapy

Author

Iacoboni, Gloria, Navarro, Víctor, Martín López, Ana África, Rejeski, Kai, Kwon, Mi, Jalowiec, Katarzyna Aleksandra, Amat, Paula, Reguera-Ortega, Juan Luis, Gallur, Laura, Blumenberg, Viktoria, Gutiérrez-Herrero, Sara, Roddie, Claire, Benzaquén, Ana, Delgado-Serrano, Javier, Sánchez-Salinas, Mario Andrés, Bailen, Rebeca, Carpio, Cecilia, López-Corral, L., Hernani, Rafael, Bastos-Oreiro, Mariana, O'Reilly, Maeve, Martín-Martín, Lourdes, Subklewe, Marion, Barba, Pere, Iacoboni, Gloria, Navarro, Víctor, Martín López, Ana África, Rejeski, Kai, Kwon, Mi, Jalowiec, Katarzyna Aleksandra, Amat, Paula, Reguera-Ortega, Juan Luis, Gallur, Laura, Blumenberg, Viktoria, Gutiérrez-Herrero, Sara, Roddie, Claire, Benzaquén, Ana, Delgado-Serrano, Javier, Sánchez-Salinas, Mario Andrés, Bailen, Rebeca, Carpio, Cecilia, López-Corral, L., Hernani, Rafael, Bastos-Oreiro, Mariana, O'Reilly, Maeve, Martín-Martín, Lourdes, Subklewe, Marion, and Barba, Pere

Abstract

[Purpose] Approximately 30%-40% of patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) infused with CD19-targeted chimeric antigen receptor (CAR) T cells achieve durable responses. Consensus guidelines suggest avoiding bendamustine before apheresis, but specific data in this setting are lacking. We report distinct outcomes after CAR T-cell therapy according to previous bendamustine exposure., [Methods] The study included CAR T-cell recipients from seven European sites. Safety, efficacy, and CAR T-cell expansion kinetics were analyzed according to preapheresis bendamustine exposure. Additional studies on the impact of the washout period and bendamustine dose were performed. Inverse probability treatment weighting (IPTW) and propensity score matching (PSM) analyses were carried out for all efficacy comparisons between bendamustine-exposed and bendamustine-naïve patients., [Results] The study included 439 patients with R/R LBCL infused with CD19-targeted commercial CAR T cells, of whom 80 had received bendamustine before apheresis. Exposed patients had significantly lower CD3+ cells and platelets at apheresis. These patients had a lower overall response rate (ORR, 53% v 72%; P < .01), a shorter progression-free survival (PFS, 3.1 v 6.2 months; P = .04), and overall survival (OS, 10.3 v 23.5 months; P = .01) in comparison with the bendamustine-naïve group. Following adjustment methods for baseline variables, these differences were mitigated. Focusing on the impact of bendamustine washout before apheresis, those with recent (<9 months) exposure (N = 42) displayed a lower ORR (40% v 72%; P < .01), shorter PFS (1.3 v 6.2 months; P < .01), and OS (4.6 v 23.5 months; P < .01) in comparison with bendamustine-naïve patients. These differences remained significant after IPTW and PSM analysis. Conversely, the cumulative dose of bendamustine before apheresis did not affect CAR-T efficacy outcomes., [Conclusion] Recent bendamustine exposure before apheresis was associated with negative treatment outcomes after CD19-targeted CAR T-cell therapy and should be therefore avoided in CAR T-cell candidates.

Published
2024

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