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Article ; Online: Mapping Systemic Inflammation and Antibody Responses in Multisystem Inflammatory Syndrome in Children (MIS-C).

Gruber, Conor N / Patel, Roosheel S / Trachtman, Rebecca / Lepow, Lauren / Amanat, Fatima / Krammer, Florian / Wilson, Karen M / Onel, Kenan / Geanon, Daniel / Tuballes, Kevin / Patel, Manishkumar / Mouskas, Konstantinos / O'Donnell, Timothy / Merritt, Elliot / Simons, Nicole W / Barcessat, Vanessa / Del Valle, Diane M / Udondem, Samantha / Kang, Gurpawan /

Agashe, Charuta / Karekar, Neha / Grabowska, Joanna / Nie, Kai / Le Berichel, Jessica / Xie, Hui / Beckmann, Noam / Gangadharan, Sandeep / Ofori-Amanfo, George / Laserson, Uri / Rahman, Adeeb / Kim-Schulze, Seunghee / Charney, Alexander W / Gnjatic, Sacha / Gelb, Bruce D / Merad, Miriam / Bogunovic, Dusan

Cell

2023 Volume 186, Issue 15, Page(s) 3325

Language	English
Publishing date	2023-07-19
Publishing country	United States
Document type	Published Erratum
ZDB-ID	187009-9
ISSN	1097-4172 ; 0092-8674
ISSN (online)	1097-4172
ISSN	0092-8674
DOI	10.1016/j.cell.2023.06.012
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Article ; Online: Author Correction: Gemcitabine and cisplatin plus nivolumab as organ-sparing treatment for muscle-invasive bladder cancer: a phase 2 trial.

Galsky, Matthew D / Daneshmand, Siamak / Izadmehr, Sudeh / Gonzalez-Kozlova, Edgar / Chan, Kevin G / Lewis, Sara / Achkar, Bassam El / Dorff, Tanya B / Cetnar, Jeremy Paul / Neil, Brock O / D'Souza, Anishka / Mamtani, Ronac / Kyriakopoulos, Christos / Jun, Tomi / Gogerly-Moragoda, Mahalya / Brody, Rachel / Xie, Hui / Nie, Kai / Kelly, Geoffrey /

Nature medicine

2024 Volume 30, Issue 4, Page(s) 1211

Language	English
Publishing date	2024-01-20
Publishing country	United States
Document type	Published Erratum
ZDB-ID	1220066-9
ISSN	1546-170X ; 1078-8956
ISSN (online)	1546-170X
ISSN	1078-8956
DOI	10.1038/s41591-024-02814-0
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Article ; Online: Gemcitabine and cisplatin plus nivolumab as organ-sparing treatment for muscle-invasive bladder cancer: a phase 2 trial.

Nature medicine

2023 Volume 29, Issue 11, Page(s) 2825–2834

Abstract: Cystectomy is a standard treatment for muscle-invasive bladder cancer (MIBC), but it is life-altering. We initiated a phase 2 study in which patients with MIBC received four cycles of gemcitabine, cisplatin, plus nivolumab followed by clinical restaging. ...

Abstract	Cystectomy is a standard treatment for muscle-invasive bladder cancer (MIBC), but it is life-altering. We initiated a phase 2 study in which patients with MIBC received four cycles of gemcitabine, cisplatin, plus nivolumab followed by clinical restaging. Patients achieving a clinical complete response (cCR) could proceed without cystectomy. The co-primary objectives were to assess the cCR rate and the positive predictive value of cCR for a composite outcome: 2-year metastasis-free survival in patients forgoing immediate cystectomy or <ypT1N0 in patients electing immediate cystectomy. Seventy-six patients were enrolled; of these, 33 achieved a cCR (43%, 95% confidence interval (CI): 32%, 55%), and 32 of 33 who achieved a cCR opted to forgo immediate cystectomy. The positive predictive value of cCR was 0.97 (95% CI: 0.91, 1), meeting the co-primary objective. The most common adverse events were fatigue, anemia, neutropenia and nausea. Somatic alterations in pre-specified genes (ATM, RB1, FANCC and ERCC2) or increased tumor mutational burden did not improve the positive predictive value of cCR. Exploratory analyses of peripheral blood mass cytometry and soluble protein analytes demonstrated an association between the baseline and on-treatment immune contexture with clinical outcomes. Stringently defined cCR after gemcitabine, cisplatin, plus nivolumab facilitated bladder sparing and warrants further study. ClinicalTrials.gov identifier: NCT03451331 .<br />
MeSH term(s)	Humans ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Cisplatin/therapeutic use ; Deoxycytidine/therapeutic use ; Disease-Free Survival ; Gemcitabine ; Muscles ; Neoadjuvant Therapy ; Neoplasm Invasiveness ; Nivolumab/therapeutic use ; Urinary Bladder Neoplasms/drug therapy ; Urinary Bladder Neoplasms/pathology ; Xeroderma Pigmentosum Group D Protein
Chemical Substances	Cisplatin (Q20Q21Q62J) ; Deoxycytidine (0W860991D6) ; ERCC2 protein, human (EC 5.99.-) ; Gemcitabine ; Nivolumab (31YO63LBSN) ; Xeroderma Pigmentosum Group D Protein (EC 3.6.4.12)
Language	English
Publishing date	2023-10-02
Publishing country	United States
Document type	Clinical Trial, Phase II ; Journal Article
ZDB-ID	1220066-9
ISSN	1546-170X ; 1078-8956
ISSN (online)	1546-170X
ISSN	1078-8956
DOI	10.1038/s41591-023-02568-1
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Article: Mapping Systemic Inflammation and Antibody Responses in Multisystem Inflammatory Syndrome in Children (MIS-C)

Gruber, Conor N / Patel, Roosheel S / Trachtman, Rebecca / Lepow, Lauren / Amanat, Fatima / Krammer, Florian / Wilson, Karen M / Onel, Kenan / Geanon, Daniel / Tuballes, Kevin / Patel, Manishkumar / Mouskas, Konstantinos / O’Donnell, Timothy / Merritt, Elliot / Simons, Nicole W / Barcessat, Vanessa / Del Valle, Diane M / Udondem, Samantha / Kang, Gurpawan /

Gangadharan, Sandeep / Ofori-Amanfo, George / Laserson, Uri / Rahman, Adeeb / Kim-Schulze, Seunghee / Charney, Alexander W / Gnjatic, Sacha / Gelb, Bruce D / Merad, Miriam / Bogunovic, Dusan

Cell. 2020 Nov. 12, v. 183, no. 4

2020

Abstract: Initially, children were thought to be spared from disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, a month into the epidemic, a novel multisystem inflammatory syndrome in children (MIS-C) emerged. Herein, we ... ...

Abstract	Initially, children were thought to be spared from disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, a month into the epidemic, a novel multisystem inflammatory syndrome in children (MIS-C) emerged. Herein, we report on the immune profiles of nine MIS-C cases. All MIS-C patients had evidence of prior SARS-CoV-2 exposure, mounting an antibody response with intact neutralization capability. Cytokine profiling identified elevated signatures of inflammation (IL-18 and IL-6), lymphocytic and myeloid chemotaxis and activation (CCL3, CCL4, and CDCP1), and mucosal immune dysregulation (IL-17A, CCL20, and CCL28). Immunophenotyping of peripheral blood revealed reductions of non-classical monocytes, and subsets of NK and T lymphocytes, suggesting extravasation to affected tissues. Finally, profiling the autoantigen reactivity of MIS-C plasma revealed both known disease-associated autoantibodies (anti-La) and novel candidates that recognize endothelial, gastrointestinal, and immune-cell antigens. All patients were treated with anti-IL-6R antibody and/or IVIG, which led to rapid disease resolution.
Keywords	Severe acute respiratory syndrome coronavirus 2 ; antibody formation ; autoantibodies ; chemotaxis ; gastrointestinal system ; immunophenotyping ; inflammation ; interleukin-17 ; interleukin-18 ; interleukin-6 ; monocytes ; mucosal immunity ; neutralization
Language	English
Dates of publication	2020-1112
Size	p. 982-995.e14.
Publishing place	Elsevier Inc.
Document type	Article
Note	NAL-AP-2-clean
ZDB-ID	187009-9
ISSN	1097-4172 ; 0092-8674
ISSN (online)	1097-4172
ISSN	0092-8674
DOI	10.1016/j.cell.2020.09.034
Database	NAL-Catalogue (AGRICOLA)

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Article ; Online: Immune Profiling Mass Cytometry Assay Harmonization: Multicenter Experience from CIMAC-CIDC.

Sahaf, Bita / Pichavant, Mina / Lee, Brian H / Duault, Caroline / Thrash, Emily M / Davila, Melanie / Fernandez, Nicolas / Millerchip, Karen / Bentebibel, Salah-Eddine / Haymaker, Cara / Sigal, Natalia / Del Valle, Diane M / Ranasinghe, Srinika / Fayle, Sarah / Sanchez-Espiridion, Beatriz / Zhang, Jiexin / Bernatchez, Chantale / Wu, Catherine J / Wistuba, Ignacio I /

Kim-Schulze, Seunghee / Gnjatic, Sacha / Bendall, Sean C / Song, Minkyung / Thurin, Magdalena / Lee, J Jack / Maecker, Holden T / Rahman, Adeeb

Clinical cancer research : an official journal of the American Association for Cancer Research

2021 Volume 27, Issue 18, Page(s) 5062–5071

Abstract: Purpose: The Cancer Immune Monitoring and Analysis Centers - Cancer Immunologic Data Commons (CIMAC-CIDC) Network is supported by the NCI to identify biomarkers of response to cancer immunotherapies across clinical trials using state-of-the-art assays. ... ...

Abstract	Purpose: The Cancer Immune Monitoring and Analysis Centers - Cancer Immunologic Data Commons (CIMAC-CIDC) Network is supported by the NCI to identify biomarkers of response to cancer immunotherapies across clinical trials using state-of-the-art assays. A primary platform for CIMAC-CIDC studies is cytometry by time of flight (CyTOF), performed at all CIMAC laboratories. To ensure the ability to generate comparable CyTOF data across labs, a multistep cross-site harmonization effort was undertaken. Experimental design: We first harmonized standard operating procedures (SOPs) across the CIMAC sites. Because of a new acquisition protocol comparing original narrow- or new wide-bore injector introduced by the vendor (Fluidigm), we also tested this protocol across sites before finalizing the harmonized SOP. We then performed cross-site assay harmonization experiments using five shared cryopreserved and one lyophilized internal control peripheral blood mononuclear cell (PBMC) with a shared lyophilized antibody cocktail consisting of 14 isotype-tagged antibodies previously validated, plus additional liquid antibodies. These reagents and samples were distributed to the CIMAC sites and the data were centrally analyzed by manual gating and automated methods (Astrolabe). Results: Average coefficients of variation (CV) across sites for each cell population were reported and compared with a previous multisite CyTOF study. We reached an intersite CV of under 20% for most cell subsets, very similar to a previously published study. Conclusions: These results establish the ability to reproduce CyTOF data across sites in multicenter clinical trials, and also highlight the importance of quality control procedures, such as the use of spike-in control samples, for tracking variability in this assay.
MeSH term(s)	Biomarkers, Tumor/analysis ; Flow Cytometry ; Humans ; Leukocytes, Mononuclear ; Monitoring, Immunologic ; Neoplasms/blood ; Neoplasms/immunology ; Neoplasms/pathology
Chemical Substances	Biomarkers, Tumor
Language	English
Publishing date	2021-07-15
Publishing country	United States
Document type	Journal Article ; Multicenter Study ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	1225457-5
ISSN	1557-3265 ; 1078-0432
ISSN (online)	1557-3265
ISSN	1078-0432
DOI	10.1158/1078-0432.CCR-21-2052
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Application of a 27-protein candidate cardiovascular surrogate endpoint to track risk ascendancy and resolution in COVID-19.

Paterson, Clare / Hagar, Yolanda / Hinterberg, Michael A / Charney, Alexander W / Del Valle, Diane M / Filbin, Michael R / Gnjatic, Sacha / Goldman, Jason D / Hacohen, Nir / Heath, James R / Hillenbrand, Rainer / Jennings, Lori L / Kim-Schulze, Seunghee / Magis, Andrew T / Merad, Miriam / Mouskas, Konstantinos / Simons, Nicole W / Williams, Stephen A

medRxiv

Abstract: Background: There is an urgent need for tools allowing the early prognosis and subsequent monitoring of individuals with heterogeneous COVID-19 disease trajectories. Pre-existing cardiovascular (CV) disease is a leading risk factor for COVID-19 ... ...

Abstract	Background: There is an urgent need for tools allowing the early prognosis and subsequent monitoring of individuals with heterogeneous COVID-19 disease trajectories. Pre-existing cardiovascular (CV) disease is a leading risk factor for COVID-19 susceptibility and poor outcomes, and cardiac involvement is prevalent in COVID-19 patients both during the acute phase as well as in convalescence. The utility of traditional CV risk biomarkers in mild COVID-19 disease or across disease course is poorly understood. We sought to determine if a previously validated 27-protein predictor of CV outcomes served a purpose in COVID-19. Methods: The 27-protein test of residual CV (RCV) risk was applied without modification to n=860 plasma samples from hospitalized and non-hospitalized SARS-CoV-2 infected individuals at disease presentation from three independent cohorts to predict COVID-19 severity and mortality. The same test was applied to an additional n=991 longitudinal samples to assess sensitivity to change in CV risk throughout the course of infection into convalescence. Results: In each independent cohort, RCV predictions were significantly related to maximal subsequent COVID-19 severity and to mortality. At the baseline blood draw, the mean protein-predicted likelihood of an event in subjects who died during the study period ranged from 88-99% while it ranged from 8-36% in subjects who were not admitted to hospital. Additionally, the test outperformed existing risk predictors based on commonly used laboratory chemistry values or presence of comorbidities. Application of the RCV test to sequential samples showed dramatic increases in risk during the first few days of infection followed by risk reduction in the survivors; a period of catastrophically high cardiovascular risk (above 50%) typically lasted 8-12 days and had not resolved to normal levels in most people within that timescale. Conclusions: The finding that a 27-protein candidate CV surrogate endpoint developed in multi-morbid patients prior to the pandemic is both prognostic and acutely sensitive to the adverse effects of COVID-19 suggests that this disease activates the same biologic risk-related mechanisms. The test may be useful for monitoring recovery and drug response.
Keywords	covid19
Language	English
Publishing date	2021-02-01
Publisher	Cold Spring Harbor Laboratory Press
Document type	Article ; Online
DOI	10.1101/2021.01.28.21250129
Database	COVID19

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Article ; Online: Mapping Systemic Inflammation and Antibody Responses in Multisystem Inflammatory Syndrome in Children (MIS-C).

Gangadharan, Sandeep / Ofori-Amanfo, George / Laserson, Uri / Rahman, Adeeb / Kim-Schulze, Seunghee / Charney, Alexander W / Gnjatic, Sacha / Gelb, Bruce D / Merad, Miriam / Bogunovic, Dusan

Cell

2020 Volume 183, Issue 4, Page(s) 982–995.e14

Abstract	Initially, children were thought to be spared from disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, a month into the epidemic, a novel multisystem inflammatory syndrome in children (MIS-C) emerged. Herein, we report on the immune profiles of nine MIS-C cases. All MIS-C patients had evidence of prior SARS-CoV-2 exposure, mounting an antibody response with intact neutralization capability. Cytokine profiling identified elevated signatures of inflammation (IL-18 and IL-6), lymphocytic and myeloid chemotaxis and activation (CCL3, CCL4, and CDCP1), and mucosal immune dysregulation (IL-17A, CCL20, and CCL28). Immunophenotyping of peripheral blood revealed reductions of non-classical monocytes, and subsets of NK and T lymphocytes, suggesting extravasation to affected tissues. Finally, profiling the autoantigen reactivity of MIS-C plasma revealed both known disease-associated autoantibodies (anti-La) and novel candidates that recognize endothelial, gastrointestinal, and immune-cell antigens. All patients were treated with anti-IL-6R antibody and/or IVIG, which led to rapid disease resolution.
MeSH term(s)	Adolescent ; Antibodies, Viral/blood ; Autoantibodies/blood ; Betacoronavirus/immunology ; Betacoronavirus/isolation & purification ; COVID-19 ; Chemokine CCL3/metabolism ; Child ; Child, Preschool ; Coronavirus Infections/complications ; Coronavirus Infections/pathology ; Coronavirus Infections/virology ; Female ; Humans ; Immunity, Humoral ; Infant ; Infant, Newborn ; Inflammation/metabolism ; Inflammation/pathology ; Interleukin-17/metabolism ; Interleukin-18/metabolism ; Killer Cells, Natural/cytology ; Killer Cells, Natural/metabolism ; Male ; Pandemics ; Pneumonia, Viral/complications ; Pneumonia, Viral/pathology ; Pneumonia, Viral/virology ; SARS-CoV-2 ; Systemic Inflammatory Response Syndrome/immunology ; Systemic Inflammatory Response Syndrome/metabolism ; Systemic Inflammatory Response Syndrome/pathology ; T-Lymphocytes/cytology ; T-Lymphocytes/metabolism ; Young Adult
Chemical Substances	Antibodies, Viral ; Autoantibodies ; Chemokine CCL3 ; Interleukin-17 ; Interleukin-18
Keywords	covid19
Language	English
Publishing date	2020-09-14
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	187009-9
ISSN	1097-4172 ; 0092-8674
ISSN (online)	1097-4172
ISSN	0092-8674
DOI	10.1016/j.cell.2020.09.034
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Article ; Online: Network for Biomarker Immunoprofiling for Cancer Immunotherapy: Cancer Immune Monitoring and Analysis Centers and Cancer Immunologic Data Commons (CIMAC-CIDC).

Chen, Helen X / Song, Minkyung / Maecker, Holden T / Gnjatic, Sacha / Patton, David / Lee, J Jack / Adam, Stacey J / Moravec, Radim / Liu, Xiaole Shirley / Cerami, Ethan / Lindsay, James / Tang, Ming / Hodi, F Stephen / Wu, Catherine J / Wistuba, Ignacio I / Al-Atrash, Gheath / Bernatchez, Chantale / Bendall, Sean C / Hewitt, Stephen M /

Clinical cancer research : an official journal of the American Association for Cancer Research

2021 Volume 27, Issue 18, Page(s) 5038–5048

Abstract: Purpose: Immunoprofiling to identify biomarkers and integration with clinical trial outcomes are critical to improving immunotherapy approaches for patients with cancer. However, the translational potential of individual studies is often limited by ... ...

Abstract	Purpose: Immunoprofiling to identify biomarkers and integration with clinical trial outcomes are critical to improving immunotherapy approaches for patients with cancer. However, the translational potential of individual studies is often limited by small sample size of trials and the complexity of immuno-oncology biomarkers. Variability in assay performance further limits comparison and interpretation of data across studies and laboratories. Experimental design: To enable a systematic approach to biomarker identification and correlation with clinical outcome across trials, the Cancer Immune Monitoring and Analysis Centers and Cancer Immunologic Data Commons (CIMAC-CIDC) Network was established through support of the Cancer Moonshot Results: The CIMAC-CIDC Network is composed of four academic centers with multidisciplinary expertise in cancer immunotherapy that perform validated and harmonized assays for immunoprofiling and conduct correlative analyses. A data coordinating center (CIDC) provides the computational expertise and informatics platforms for the storage, integration, and analysis of biomarker and clinical data. Conclusions: This overview highlights strategies for assay harmonization to enable cross-trial and cross-site data analysis and describes key elements for establishing a network to enhance immuno-oncology biomarker development. These include an operational infrastructure, validation and harmonization of core immunoprofiling assays, platforms for data ingestion and integration, and access to specimens from clinical trials. Published in the same volume are reports of harmonization for core analyses: whole-exome sequencing, RNA sequencing, cytometry by time of flight, and IHC/immunofluorescence.
MeSH term(s)	Biomarkers, Tumor/immunology ; Humans ; Immunotherapy ; Monitoring, Immunologic ; Neoplasms/immunology ; Neoplasms/therapy
Chemical Substances	Biomarkers, Tumor
Language	English
Publishing date	2021-01-08
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	1225457-5
ISSN	1557-3265 ; 1078-0432
ISSN (online)	1557-3265
ISSN	1078-0432
DOI	10.1158/1078-0432.CCR-20-3241
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: Mapping Systemic Inflammation and Antibody Responses in Multisystem Inflammatory Syndrome in Children (MIS-C)

Gruber, Conor N / Patel, Roosheel S / Trachtman, Rebecca / Lepow, Lauren / Amanat, Fatima / Krammer, Florian / Wilson, Karen M / Onel, Kenan / Geanon, Daniel / Tuballes, Kevin / Patel, Manishkumar / Mouskas, Konstantinos / O039, / Donnell, Timothy / Merritt, Elliot / Simons, Nicole W / Barcessat, Vanessa / Del Valle, Diane M / Udondem, Samantha /

Kang, Gurpawan / Gangadharan, Sandeep / Ofori-Amanfo, George / Laserson, Uri / Rahman, Adeeb / Kim-Schulze, Seunghee / Charney, Alexander W / Gnjatic, Sacha / Gelb, Bruce D / Merad, Miriam / Bogunovic, Dusan

Cell

Abstract	Initially, children were thought to be spared from disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, a month into the epidemic, a novel multisystem inflammatory syndrome in children (MIS-C) emerged. Herein, we report on the immune profiles of nine MIS-C cases. All MIS-C patients had evidence of prior SARS-CoV-2 exposure, mounting an antibody response with intact neutralization capability. Cytokine profiling identified elevated signatures of inflammation (IL-18 and IL-6), lymphocytic and myeloid chemotaxis and activation (CCL3, CCL4, and CDCP1), and mucosal immune dysregulation (IL-17A, CCL20, and CCL28). Immunophenotyping of peripheral blood revealed reductions of non-classical monocytes, and subsets of NK and T lymphocytes, suggesting extravasation to affected tissues. Finally, profiling the autoantigen reactivity of MIS-C plasma revealed both known disease-associated autoantibodies (anti-La) and novel candidates that recognize endothelial, gastrointestinal, and immune-cell antigens. All patients were treated with anti-IL-6R antibody and/or IVIG, which led to rapid disease resolution.
Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #756809
Database	COVID19

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