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1. Impact of SARS-CoV-2 vaccination and monoclonal antibodies on outcome post CD19-CAR-T: an EPICOVIDEHA survey

Author

Jaap A. van Doesum, Jon Salmanton-García, Francesco Marchesi, Roberta Di Blasi, Iker Falces-Romero, Alba Cabirta, francesca farina, caroline besson, Barbora Weinbergerová, Jens Van Praet, Martin Schönlein, Alberto Lopez-Garcia, Sylvain Lamure, Anna Guidetti, Cristina De Ramón-Sánchez, Josip Batinic, Eleni Gavriilaki, Athanasios Tragiannidis, Maria Chiara Tisi, Gaëtan Plantefeve, Verena Petzer, Irati Ormazabal-Velez, Joyce Marques de Almeida, Monia Marchetti, Johan A. Maertens, Marina Machado, Austin G Kulasekararaj, José Ángel Hernández-Rivas, Maria Gomes da Silva, Noemí Fernández, Ildefonso Espigado, Lubos Drgona, Giulia Dragonetti, Elisabetta Metafuni, Maria Calbacho, Ola Blennow, Dominik Wolf, Bjorn van Anrooij, Raquel Nunes Rodrigues, Anna Nordlander, Juan-Alberto MARTÍN-GONZÁLEZ, Raphaël Lievin, Moraima Jiménez, Stefanie K Grafe, Ramon Garcia-Sanz, Raúl Córdoba, Laman Rahimli, Tom van Meerten, Oliver A Cornely, and Livio Pagano

Subjects
Hematology
Abstract

Patients with previous CD19 directed chimeric antigen receptor T cell therapy (CAR T)-cell therapy have a prolonged vulnerability to viral infections. Coronavirus diseases 2019 (COVID-19) has a great impact and has previously been shown to cause high mortality in this population. Until now, real world data of the impact of vaccination and treatment on patients with COVID-19 after CD19 directed CAR T-cell therapy are lacking. Therefore, this multicenter retrospective study was conducted with data from the EPICOVIDEHA survey. Sixty-four patients were identified. The overall mortality caused by COVID-19 was 31%. Patients infected with the Omicron variant had a significantly lower risk of death due to COVID-19 compared to patients infected with previous variants (7% versus 58% (P=0.012)). Twenty-six patients were vaccinated at time of COVID-19 diagnosis. Two vaccinations showed marked but unsignificant reduction risk of COVID-19 caused mortality (33.3% versus 14.2% (P=0.379)).Also the course of disease appears milder with less frequent ICU admissions (39% versus 14% (P=0.054)) and shorter duration of hospitalization (7 versus 27.5 days (P=0.022)). Of the available treatment options, only monoclonal antibodies seemed to be effectively reducing mortality from 32% to zero (P=0.036). We conclude that survival rates of CAR T-cell recipients with COVID-19 improved over time and that the combination of prior vaccination and monoclonal antibody treatment significantly reduces their risk of death.

Published
2023
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2. COVID-19 and CAR T cells: a report on current challenges and future directions from the EPICOVIDEHA survey by EHA-IDWP

Author

Johan Maertens, Austin Kulesekararaj, Carolina Garcia-Vidal, Nina Khanna, Ildefonso Espigado, Alessandro Busca, Martin Hoenigl, Philipp Koehler, Anna Guidetti, Nikolai Klimko, Ramón García-Sanz, Josip Batinić, Alba Cabirta, Antonio Pagliuca, Rémy Duléry, Francesca Farina, Oliver A. Cornely, Jon Salmanton-García, Sylvain Lamure, Anna Nordlander, Francesco Passamonti, Lubos Drgona, Francesco Marchesi, Barbora Weinbergerova, Alberto Lopez-Garcia, Iker Falces-Romero, Livio Pagano, Paolo Corradini, Roberta Di Blasi, Institut Català de la Salut, [Busca A] Stem Cell Transplant Center, Azienda Ospedaliera Universitaria Città della Salute e della Scienza, Turin, Italy. [Salmanton-García J] Department I of Internal Medicine, Excellence Center for Medical Mycology (ECMM), Faculty of Medicine and University Hospital Cologne, Cologne, Germany. Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases, University Hospital Cologne, Cologne, Germany. [Corradini P] University of Milan and Fondazione IRCCS, Istituto Nazionale dei Tumori, Milan, Italy. [Marchesi F] Hematology and Stem Cell Transplant Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy. [Cabirta A] Servei d’Hematologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain. [Di Blasi R] Hôpital Saint Louis, Assistance Publique–Hopitaux de Paris (AP-HP), Paris, France, and Vall d'Hebron Barcelona Hospital Campus

Subjects
medicine.medical_specialty, CAR-T cells, Coronavirus disease 2019 (COVID-19), T-Lymphocytes, medicine.medical_treatment, Adoptive, Psychological intervention, MEDLINE, registry, Therapeutics::Biological Therapy::Immunomodulation::Immunotherapy::Immunization::Immunization, Passive::Adoptive Transfer::Immunotherapy, Adoptive [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], COVID-19 (Malaltia), Immunotherapy, Adoptive, terapéutica::terapia biológica::inmunomodulación::inmunoterapia::inmunización::inmunización pasiva::transferencia adoptiva::inmunoterapia adoptiva [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Receptors, Case fatality rate, virosis::infecciones por virus ARN::infecciones por Nidovirales::infecciones por Coronaviridae::infecciones por Coronavirus [ENFERMEDADES], Humans, Medicine, Cells::Blood Cells::Leukocytes::Leukocytes, Mononuclear::Lymphocytes::T-Lymphocytes [ANATOMY], 030304 developmental biology, 0303 health sciences, Receptors, Chimeric Antigen, Hematology, business.industry, Prevention, Teràpia cel·lular, Risk of infection, Chimeric Antigen, COVID-19, Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections [DISEASES], Immunosuppression, Stimulus Report, Chimeric antigen receptor, 3. Good health, Settore MED/15 - MALATTIE DEL SANGUE, Good Health and Well Being, Cèl·lules T, 030220 oncology & carcinogenesis, Immunotherapy, Infection, business, células::células sanguíneas::leucocitos::leucocitos mononucleares::linfocitos::linfocitos T [ANATOMÍA]
Abstract

Patients receiving chimeric antigen receptor T cells (CAR-T cells) therapy may be particularly susceptible to coronavirus disease 2019 (COVID-19) because of several factors including the immunosuppression associated to the underlying disease and delayed cytopenias. Regrettably, data on outcomes of CAR-T recipients with COVID-19 are extremely scarce. The aim of this study was to investigate the characteristics and outcomes of COVID-19 in patients treated with CAR-T therapy. The European Hematology Association - Scientific Working Group Infection in Hematology endorsed a survey to collect and analyze data from patients developing COVID-19 after CAR-T therapy. Overall, 459 patients treated with CAR-T cells were reported from 18 European centers. The prevalence of COVID-19 cases was 4.8%. Median time from CAR-T therapy and COVID-19 diagnosis was 169 days. Severe infection occurred in 66.7% of patients and 43.3% of the subjects required admission to ICU. The COVID-19 mortality was 33%. In multivariable analysis, the disease status at the time of COVID-19 trended marginally towards adverse outcome (P=0.075). In conclusion, we documented a high fatality rate for CAR-T patients with COVID-19, supporting the need to design successful interventions to mitigate the risk of infection in this vulnerable group of patients.

Published
2022
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3. Cellular and humoral immunogenicity of the mRNA-1273 SARS-CoV-2 vaccine in patients with hematologic malignancies

Author

Marta Crespo, Eva Catalá, Isabel Ruiz-Camps, Maria Laura Fox, Guillermo Villacampa, Mónica Martínez-Gallo, Gemma Pujadas, Pau Abrisqueta, Candela Fernández-Naval, Soraya Peralta-Garzón, David Valcárcel, Tomás Pumarola, Moraima Jiménez, Magda Campins, Daniel Medina-Gil, Pere Barba, Alba Cabirta, Cristina Hernández, M. Hernández, Alberto Orfao, Francesc Bosch, Ana Marín-Niebla, Guillermo Ortí, Mercedes Valentín, Marcos González, Juliana Esperalba, Elisa Roldán, Mercedes Gironella, Carlota Pagès Geli, Generalitat de Catalunya, Institut Català de la Salut, [Jiménez M, Roldán E, Gironella M, Fox L, Orti G, Barba P, Valcárcel D, Bosch F, Abrisqueta P] Servei d’Hematologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Experimental Hematology, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain. [Fernández-Naval C, Pumarola T, Esperalba J] Servei de Microbiologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. [Villacampa G] Oncology Data Science (ODysSey) Group, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Martinez-Gallo M, Hernández M] Servei d’Immunologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. Departament de Biologia Cel·lular, Fisiologia i Immunologia, Universitat Autònoma de Barcelona, Bellaterra, Spain. [Medina-Gil D, Peralta-Garzón S, Pujadas G, Hernández C, Pagès C, Crespo M] Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain. Experimental Hematology, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Cabirta A, Catalá E, Valentín M, Marín-Niebla A] Servei d’Hematologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Experimental Hematology, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Orfao A] Department of Medicine and Cytometry General ServiceNucleus, Cancer Research Centre (IBMCC/CSIC/USAL/IBSAL), Salamanca, Spain. [González M] Department of Hematology, University Hospital of Salamanca (HUS/IBSAL), CIBERONC–CB16/12/00233 and Center for Cancer Research–IBMCC (USAL-CSIC), Salamanca, Spain. [Campins M] Servei de Medicina Preventiva i Epidemiologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Ruiz-Camps I] Servei de Malalties Infeccioses, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus

Subjects
COVID-19 Vaccines, Immunobiology and Immunotherapy, Clinical Trials and Observations, T cell, Antibodies, Viral, Hypogammaglobulinemia, Immunogenicity, Vaccine, medicine, virosis::infecciones por virus ARN::infecciones por Nidovirales::infecciones por Coronaviridae::infecciones por Coronavirus [ENFERMEDADES], Humans, RNA, Messenger, Immune System Phenomena::Antibody Formation::Immunogenicity, Vaccine [PHENOMENA AND PROCESSES], neoplasias::neoplasias por localización::neoplasias hematológicas [ENFERMEDADES], BNT162 Vaccine, Aged, Response rate (survey), Messenger RNA, business.industry, SARS-CoV-2, Immunogenicity, Antibody titer, COVID-19, Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections [DISEASES], Regular Article, Hematology, Aplasia, Neoplasms::Neoplasms by Site::Hematologic Neoplasms [DISEASES], medicine.disease, Antibodies, Neutralizing, medicine.anatomical_structure, Hematologic Neoplasms, Immunology, Humoral immunity, Sang - Malalties, fenómenos del sistema inmunitario::formación de anticuerpos::inmunogenicidad vacunal [FENÓMENOS Y PROCESOS], business, Immunoglobulines, COVID-19 (Malaltia) - Vacunació, 2019-nCoV Vaccine mRNA-1273
Abstract

Recent studies have shown a suboptimal humoral response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) messenger RNA (mRNA) vaccines in patients diagnosed with hematologic malignancies; however, data about cellular immunogenicity are scarce. The aim of this study was to evaluate both the humoral and cellular immunogenicity 1 month after the second dose of the mRNA-1273 vaccine. Antibody titers were measured by using the Elecsys and LIAISON anti–SARS-CoV-2 S assays, and T-cell response was assessed by using interferon-γ release immunoassay technology. Overall, 76.3% (184 of 241) of patients developed humoral immunity, and the cellular response rate was 79% (184 of 233). Hypogammaglobulinemia, lymphopenia, active hematologic treatment, and anti-CD20 therapy during the previous 6 months were associated with an inferior humoral response. Conversely, age >65 years, active disease, lymphopenia, and immunosuppressive treatment of graft-versus-host disease (GVHD) were associated with an impaired cellular response. A significant dissociation between the humoral and cellular responses was observed in patients treated with anti-CD20 therapy (the humoral response was 17.5%, whereas the cellular response was 71.1%). In these patients, B-cell aplasia was confirmed while T-cell counts were preserved. In contrast, humoral response was observed in 77.3% of patients undergoing immunosuppressive treatment of GVHD, whereas only 52.4% had a cellular response. The cellular and humoral responses to the SARS-CoV-2 mRNA-1273 vaccine in patients with hematologic malignancies are highly influenced by the presence of treatments such as anti-CD20 therapy and immunosuppressive agents. This observation has implications for the further management of these patients., The authors also thank the Cellex Foundation for providing research facilities and equipment and the CERCA Programme/Generalitat de Catalunya for institutional support.

Published
2021

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