SANTA MONICA, Calif. & MENLO PARK, Calif.--(BUSINESS WIRE)-- Kite Pharma, a Gilead Company (Nasdaq: GILD) and Refuge Biotechnologies Inc., (Refuge), today announced that Kite has entered into an exclusive, worldwide license agreement with Refuge, a synthetic biology company for cancer immunotherapy, for exclusive rights to utilize Refuges proprietary The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. In this bidirectional relationship, colonization with various bacterial species is correlated with a reduced or elevated risk of certain cancers. Sadik served as Executive Director at Kite Pharma and led the development of manufacturing processes for autologous CAR-T and TCR-based cell therapies. [Mechanisms of resistance and escape to CAR-T cells]. Results have a great therapeutic implication to develop an efficient and universal blocker for SARS CoV-2. Dr. Marincola is currently Global Head of Research at Kite Pharma, Santa Monica, California. Search the world's information, including webpages, images, videos and more. Events Page. Notably, the gut microflora could potentially play a direct or indirect role in tumor initiation and progression by inducing chronic inflammation and producing toxins and metabolites. J Immunother Cancer. Please refer to the company's website or job descriptions to learn more about them. PFS was defined as the time from the brexucabtagene autoleucel infusion date to the date of PD or death from any cause. DOR: time from the first OR to PD/death. Search the world's information, including webpages, images, videos and more. J. Exp. Please note thatJournal of Translational Medicineis no longer considering submissions of study protocols. It is determined using KM estimates. -, Eshhar Z., Waks T., Gross G., Schindler D.G. Delgoffe GM, Xu C, Mackall CL, Green MR, Gottschalk S, Speiser DE, Zehn D, Beavis PA. Cancer Cell. The tumor-promoting role of tumor microenvironment (TME) in colorectal cancer has been widely investigated in cancer biology. Assist in implementing innovative legal products and procedures. If no prior splenomegaly, the increase must be 2 cm from baseline; new/recurrent splenomegaly; new or clear progression of pre-existing NMLs; new lesion; new/recurrent bone marrow involvement. Please refer to your web browser's help function for assistance on how to change your preferences. CR: disappearance of all detectable clinical evidence; PR: 50% decrease in the sum of the product of diameters (SPD) of up to 6 largest dominant nodal masses and >= 50% decrease in SPD of spleen/liver nodules; PD: appearance of any new lesions or >= 50% increase in SPD of more than one node or >= 50% increase in longest diameter of a previously identified node or >50% increase from nadir in the SPD of any previous lesions; SD: failure to attain CR/PR or PD. PR: 50% decrease in the SPD of up to 6 largest dominant nodal masses and 50% decrease in SPD of spleen/liver nodules; no increase in size of nodes, liver, or spleen and no new sites of disease; splenic and hepatic nodules must regress by 50% in the SPD; if participant has persistent bone marrow involvement and otherwise meets criteria for CR, will then be considered a PR; typically FDG-avid lymphoma (the post-treatment PET scan should be positive in at least 1 previously involved site. Epub 2021 Dec 15. hX[s6+x6t:JYmvgTG'GS[_@theS | L29=>[hNnJr4_ 1993;90:720724. Our aim is to improve transparency and reproducibility within translational medicine, which is why we consider research papers regardless of outcome or significance of findings, as well as protocols for future research. Dr. Marincola is currently Global Head of Research at Kite Pharma, Santa Monica, California. h W7;IiC?oo:9hAH91$Kgj[ Search Gilead Jobs. However, to fulfill FDA Postmarketing Requirement, Cohort 3 is added to the study. However, the clinical benefits are still limited, especially in solid tumors. Dr. Marincola is Global Head of Research at Kite Pharma, Santa Monica, California. PFS was determined using the KM estimates. The attorney performs duties consistent with legal and ethical requirements as well as Company values, standards, culture and business practices. CAR design and ex vivo manipulation, including culture conditions, may play a pivotal role. BOR consists of CR (CMR/CRR), PR (PMR/PRR), SD, PD and not done. Cancer-associated fibroblasts (CAFs), as the main stromal component in TME, play an important role in promoting tumor progression and metastasis. California Privacy Statement, PRR: 50% decrease in SPD of up to 6 target measurable nodes and extra-nodal sites;absent/normal, regressed, but no increase of NMLs; spleen regressed by > 50% in length beyond normal. official website and that any information you provide is encrypted doi: 10.1073/pnas.86.24.10024. Genetic and Rare Diseases Information Center. FOIA Familiarity with information technology and infrastructure is strongly preferred. Ability to counsel internal clients on the risks associated with various options and to present creative solutions to difficult problems to achieve the desired business outcome while appropriately managing risk. Would you like email updates of new search results? OR: complete metabolic response(CMR),complete radiological response(CRR),partial MR response(PMR),partial RR(PRR).CMR:score 1(no uptake above background)/2(uptake mediastinum)/3(uptake > mediastinum but liver)with/without a residual mass on positron emission tomography 5-point scale;no new lesions.CRR:target nodes/nodal masses regressed to 1.5 cm in longest transverse diameter of lesion(LDi);no extralymphatic sites of disease;absent non-measured lesion(NMLs);organ enlargement regress to normal;no new sites;bone marrow normal by morphology. CMR: score 1(no uptake above background) / 2(uptake mediastinum) / 3(uptake > mediastinum but liver) with/without a residual mass on positron emission tomography 5-point scale; no new lesions. Wang M, Jain P, Chi TL, Chen SE, Heimberger A, Weathers SP, Zheng L, Rao AV, Rossi JM. The .gov means its official. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. doi: 10.1016/j.bulcan.2021.09.002. Santa Monica Studio asks for fans to stop leaking God of War: Ragnarok. KTE-X19 CAR T-Cell Therapy in Relapsed or Refractory Mantle-Cell Lymphoma. eCollection 2021. Managing the real estate workflow, including drafting, analyzing and negotiating real estate contracts, advising on real estate matters and interfacing with the business team that manages the real estate portfolio. Proc. Kite Pharma Biotechnology Research Santa Monica, California 98,597 followers At Kite, a Gilead Company, our singular focus is cell therapy to treat and potentially cure cancer. Specific activation and targeting of cytotoxic lymphocytes through chimeric single chains consisting of antibody-binding domains and the gamma or zeta subunits of the immunoglobulin and T-cell receptors. Detail-oriented. This Friday, were taking a look at Microsoft and Sonys increasingly bitter feud over Call of Duty and whether U.K. regulators are leaning toward torpedoing the Activision Blizzard deal. 2018 Dec;29(11-12):739-756. doi: 10.1007/s00335-018-9756-5. Combination strategies to optimize the efficacy of chimeric antigen receptor T cell therapy in haematological malignancies. He previously was President and Chief Scientific Officer at Refuge Biotechnologies, Menlo Park, California, Distinguished Research Fellow at AbbVie Corporation in Redwood City, California, Chief Research Officer at Sidra Medical and Research Center in Doha Qatar and Tenured Investigator at the National Institutes of Health, Bethesda Maryland. Page 3 of 76 . For each dimension the participant is asked for a three-level assessment of their health on the current day: "no problems" (1), "some problems" (2), "extreme problems" (3). Translational Medicine Communications will also consider reviews, methodology articles, protocols and commentaries. Dr. Marincola is an award winning fiction writer author of The Wise Men of Pizzo and the Cat Behind the Window. Description. the companion journal to Journal of Translational Medicine,is an interdisciplinary forum for all scientifically valid research from across translational medicine. Adrian has 25 years of experience in biopharmaceutical industry, was formerly the first Chief Scientific Officer of Kite Pharma and more recently, Global Head and Vice President of Translational Medicine and Santa Monica Research Site Head at Kite, a Gilead Company. 2020 Apr 2;382(14):1331-1342. doi: 10.1056/NEJMoa1914347. EQ-5D is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. Prepares and delivers trainings and tool kits for the business and helps to develop contracting processes. A schematic of determinants affecting the efficacy of CAR T-cell therapy and possible. Front Immunol. Scheme of T-cell exhaustion and T-cell activation markers. See this image and copyright information in PMC. 2020 Oct;8(2). Bookshelf 11150 Santa Monica Boulevard, Suite 350 Los Angeles, CA 90025 323-549-5225. The developers are asking those who got their hands on God of War: Ragnarok earlier than expected to be considerate. PMR: score 4 (uptake moderately > liver) /5 (uptake markedly > liver, new lesions) with reduced uptake compared with baseline and residual mass; no new lesions; responding disease at interim/residual disease at EOT. The role of exhaustion in CAR T cell therapy. 2022 May 7;11(9):2629. doi: 10.3390/jcm11092629. J Clin Oncol 2018;36 (Suppl 15):TPS3102. She is a director-at-large for SITC and is an Associate Editor for the Journal of Translational Medicine. Drafting, analyzing and negotiating complex and routine commercial contracts, including non-disclosure agreements, master services agreements, SOWs, SaaS agreements, supply chain agreements, transportation agreements, licensing and other technology agreements. Dr. Marincola is editor of several biomedical books including the SITC-affiliated Cancer Immunotherapy Principles and Practice Textbook. 2022 BioMed Central Ltd unless otherwise stated. Wang, Michael; Lundry Locke, Frederick; Munoz, Javier; Goy, Andre; Eccleston Holmes, Houston; Siddiqi, Tanya; Flinn, Ian; McSweeney, Peter A; Michael Reagan, Patrick; Thomas Hill, Brian; Jacobson, Caron A.; Rizzieri, David A.; Heffner, Leonard T.; Mary Jaglowski, Samantha; Bernard Miklos, David; Shaughnessy, Paul; Unabia, Sherry; Rossi, John M.; Jiang, Yizhou; Jain, Rajul K. Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number): Why Should I Register and Submit Results? Accessibility (14)(15), Michael Wang,1 Javier Munoz,2 Andre Goy,3 Frederick L. Locke,4 Caron A. Jacobson,5 Brian T. Hill,6 John M. Timmerman,7 Houston Holmes,8 Samantha Jaglowski,9 Ian W. Flinn,10 Peter A. McSweeney,11 David B. Miklos,12 John M. Pagel,13 Marie Jos Kersten,14 Noel Milpied,15 Henry Fung,16 Max S. Topp,17 Roch Houot,18 Amer Beitinjaneh,19 Weimin Peng,20 Lianqing Zheng,20 John M. Rossi,20 Rajul K. Jain,20 Arati V. Rao,20 and Patrick M. Reagan21, Wang M, Munoz J, Goy A, Locke FL, Jacobson CA, Hill BT, Timmerman JM, Holmes H, Jaglowski S, Flinn IW, McSweeney PA,Miklos DB, Pagel JM, Kersten MJ, Peng W,Zheng L,Rossi JM, Jain RK, Rao AV, Reagan PM, Wang, Michael L., MD(1); Munoz, Javier, MD(2); Goy, Andre, MD(3); Locke, Frederick L., MD(4); Jacobson, Caron A., MD, MMSc(5); Hill, Brian T., MD(6); Timmerman, John M., MD(7); Holmes, Houston, MD(8); Jaglowski, Samantha, MD, MPH(9); Flinn, Ian W., MD, PhD(10); McSweeney, Peter A., MD(11); Miklos, David B., MD, PhD(12); Pagel, John M., MD, PhD, DSc(13); Jose Kersten, Marie, MD, PhD(14); Peng, Weimin, MS(15); Zheng, Lianqing, PhD(15); Rossi, John M., MS(15); Jain, Rajul K., MD(15); Rao, Arati V., MD(15); Reagan, Patrick M, MD(16). (6); Timmerman, J. 2022 Jun 23;23(13):6989. doi: 10.3390/ijms23136989. Ther. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Kite has locations around the globe, including our corporate headquarters in Santa Monica, California, our cell therapy manufacturing facilities in El Segundo, California and Frederick, Maryland, and our European cell therapy manufacturing facility in Amsterdam. PMC Talk with your doctor and family members or friends about deciding to join a study. Translational Medicine Communications. PD: score 4 (uptake moderately > liver)/ 5 (uptake markedly >liver and/or new lesions) with an increase in intensity of uptake from baseline; new fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma at interim/EOT assessment; new FDG-avid foci consistent with lymphoma rather than another etiology; new/recurrent FDG-avid foci in bone marrow; an individual node/lesion must be abnormal with: LDi > 1.5 cm, increase by 50% from cross-product of LDi and perpendicular diameter (PPD) nadir, increase in LDi or shortest axis perpendicular to the LDi from nadir, the splenic length must increase by > 50% of the extent of its prior increase beyond baseline. Over the last decade remarkable progress has been made in enhancing the efficacy of CAR T therapies. Some studies have identified different types of CAFs at the single-cell level according to unique gene signatures or functions. Senior Corporate Counsel - Contracts - Remote. Alyssa holds a BS in Biochemistry from the University of California, Santa Barbara, and a PhD in Biochemistry from MIT. According to the involvement of microbiota in modulating physiological processes, any alteration in its composition and diversity has been linked to a variety of pathologies, including cancer. Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Percentage of Participants With Objective Response (OR) Per the Lugano Classification According to Independent Radiology Review Committee (IRRC) in Cohort 1 [TimeFrame:Up to 2 years], Percentage of Participants With Objective Response (OR) Per the Lugano Classification According to Independent Radiology Review Committee (IRRC) in Cohort 2 [TimeFrame:Up to 2 years], Duration of Response (DOR) in Cohort 1 [TimeFrame:Up to 15 years], Duration of Response (DOR) in Cohort 2 [TimeFrame:Up to 15 years], Percentage of Participants With Best Objective Response (BOR) as Per Investigator Assessment Determined by International Working Group (IWG) 2007 Criteria in Cohort 1 [TimeFrame:Up to 15 years], Percentage of Participants With Best Objective Response (BOR) as Per Investigator Assessment Determined by Lugano Classification in Cohort 2 [TimeFrame:Up to 15 years], Percentage of Participants With Objective Response (OR) as Per Investigator Assessment Determined by International Working Group (IWG) 2007 Criteria in Cohort 1 [TimeFrame:Up to 15 years], Percentage of Participants With Objective Response (OR) as Per Investigator Assessment Determined by Lugano Classification in Cohort 2 [TimeFrame:Up to 15 years], Progression Free Survival (PFS) in Cohort 1 [TimeFrame:Up to 15 years], Progression Free Survival (PFS) in Cohort 2 [TimeFrame:Up to 15 years], Overall Survival in Cohort 1 [TimeFrame:Up to 15 years], Overall Survival in Cohort 2 [TimeFrame:Up to 15 years], Percentage of Participants Experiencing Treatment-Emergent Adverse Events [TimeFrame:Up to 15 years], Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade [TimeFrame:Up to 15 years], Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade [TimeFrame:Up to 15 years], Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade [TimeFrame:Up to 15 years], Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade [TimeFrame:Up to 15 years], Percentage of Participants With Anti-CD19 CAR Antibodies [TimeFrame:Up to 15 years], Peak Anti-CD19 CAR T-Cell (Brexucabtagene Autoleucel) Level (Maximum Observed Plasma Concentration) in Blood [TimeFrame:Up to 15 years], Peak Serum Levels of C-Reactive Protein (CRP) in Blood [TimeFrame:Up to 15 years], Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-Gamma (IFN-), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-7, IL-8,IL-10, IL-15, and Tumor Necrosis Factor-Alpha (TNF-) in Blood [TimeFrame:Up to 15 years], Peak Serum Levels of Ferritin, Interleukin-2 Receptor Alpha (IL-2R), Intercellular Adhesion Molecule-1 (ICAM-1), Perforin, Vascular Cell Adhesion Molecule-1 (VCAM-1) in Blood [TimeFrame:Up to 15 years], Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score [TimeFrame:Baseline, Week 4, Month 3, and Month 6], Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score [TimeFrame:Baseline, Week 4, Month 3, and Month 6], Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score [TimeFrame:Baseline, Week 4, Month 3, and Month 6], Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score [TimeFrame:Baseline, Week 4, Month 3, and Month 6], Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score [TimeFrame:Baseline, Week 4, Month 3, and Month 6], Change Over Time in EQ-5D Visual Analogue Scale (VAS) Score [TimeFrame:Baseline, Week 4, Month 3, and Month 6], Anthracycline or bendamustine-containing chemotherapy and, Anti-CD20 monoclonal antibody therapy and, Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive). Chicago, Xiao X, Wang Y, Zou Z, Yang Y, Wang X, Xin X, Tu S, Li Y. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. &"+CVJ6 pP JIc%[eP#FH8Q (f45 8Ya^AvW?H2de0AZSP4%KoPd-G98t,sf$p0'ArZh4HA0)qb9J('(i:Q. A footnote in Microsoft's submission to the UK's Competition and Markets Authority (CMA) has let slip the reason behind Call of Duty's absence from the Xbox Game Pass library: Sony and Translational Signaling and System Biology section welcomes articles providing new mechanistic insights on a broad range of fields, drug action through new formulations and delivery methods, novelcellular and animal models,computational and systems biology, and innovative laboratory concepts fostering translational research from the bench to the bedside. Sci. 2022 BioMed Central Ltd unless otherwise stated. Front Immunol. Study KTE-C19-102 enrolled participants with r/r MCL who have been treated with up to 5 prior regimens including a Bruton's tyrosine kinase inhibitor (BTKi) in Cohort 1 and Cohort 2. Immunological Responses to Cancer Therapy. statement and DOR: time from the first OR to progressive disease (PD)/death. Dr. Marincola is also an award winning fiction author of The Wise Men of Pizzo and Cat Behind the Window. Natl. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Frost Brown Todd, a full-service AM Law 200 firm with more than 500 attorneys in 14 markets across eight states and Washington DC, seeks an associate with at least 5 7 years of relevant experience to join its employee benefits group, in Louisville, Indianapolis, Cincinnati, Lexington, Charleston, Columbus, Florence, Houston, Dallas, Pittsburgh, Washington after treatment with YESCARTA, contact Kite at 1-844-454-KITE (5483). Reasonable accommodations may be made to enable individuals to perform the essential functions. Excellent communication (oral and written), organization, analytical and interpersonal skills. Kite, A Gilead Company: ClinicalTrials.gov Identifier: NCT02601313 Other Study ID Numbers: KTE-C19-102 2015-005008-27 ( EudraCT Number ) First Posted: November 10, 2015 Key Record Dates: Results First Posted: September 10, 2020: Last Update Posted: May 24, 2022 Last Verified: May 2022 Kite locations. He is past-president of the Society for the Immunotherapy of Cancer (SITC) and of the International Society for Translational Medicine. Front Immunol. CMR/CRR and PMR/PRR are defined in Outcome Measure (OM) 1. 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For each dimension the participant is asked for a three-level assessment of their health on the current day: "no problems" (1), "some problems" (2), "extreme problems" (3). You have reached the maximum number of saved studies (100). All Rights Reserved. Two types of CAFs were identified using integrated data and researchers explored the functional significance of TME. Cellular Metabolism Therapy will consider research that covers any aspect of translational metabolic research,including (but not limited to): genetic disorders and epigenetic diseases; metabolic derangements causing neurodegeneration; immunometabolism; stroke; cardiovascular diseases; tumours; stem cell bioenergetics; ageing; carbohydrate, lipid, and protein metabolism. He is also Editor-in-Chief of Translational Medicine Communications. Read our, ClinicalTrials.gov Identifier: NCT02601313, Interventional Drafting, analyzing and negotiating complex and routine commercial contracts, including non-disclosure agreements, master services agreements, SOWs, SaaS agreements, supply chain agreements, transportation agreements, licensing and other technology agreements. Advertise with Us. 2014 Sep 20;32(27):3059-68. Speed37 days to first decision for all manuscripts (Median)36 days to first decision for reviewed manuscripts only (Median), Usage116,990 Downloads (2021)168 Altmetric mentions (2021). MONICA STANCIU, PhD. IDM Members' meetings for 2022 will be held from 12h45 to 14h30.A zoom link or venue to be sent out before the time.. Wednesday 16 February; Wednesday 11 May; Wednesday 10 August; Wednesday 09 November This site needs JavaScript to work properly. Zhang ZZ, Wang T, Wang XF, Zhang YQ, Song SX, Ma CQ. PMR: score 4(uptake moderately > liver) /5 (uptake markedly > liver, new lesions) with reduced uptake compared with baseline and residual mass; no new lesions; responding disease at interim/residual disease at EOT. This website uses cookies to improve your browsing experience. Dr. Marincola received his MD, summa cum laude from the University of Milan, Italy and Surgery training at Stanford University, California. As immunology has evolved to be a central discipline connected to a wide range of therapeutic areas, the number and diversity of platform technologies has also increased. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Self-confident and inspires confidence from clients. 1 In 2017, for example, after extensive research in labs and in human clinical trials around the world, the first gene therapies were approved by the Food and Drug Administration (FDA) for use in the United ZUMA-2: A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-C19 (Anti-CD19 CAR T cells) in Subjects with Relapsed/Refractory Mantle Cell Lymphoma (r/r MCL). Springer Nature. The percentage of participants with each level of problem are reported. Managing a contract matter throughout the process, from intake or drafting through negotiation and execution, and assisting the business in on-going contract management and dispute resolution. (12); Pagel, John M.(13); Jos Kersten, Marie(14); Peng, Weimin(15); Zheng, Lianqing(15); Rossi, John M.(15); Jain, Rajul K.(15); Rao, Arati V.(15); Reagan, Patrick M.(16), Wang, M.(1); Munoz, J. Limited persistence remains a significant hindrance to the development of effective CAR T therapies due to several determinants, which are encountered from the cell manufacturing step and onwards. Int J Mol Sci. sharing sensitive information, make sure youre on a federal OR: CMR, CRR, PMR, PRR. A positive change indicates an improvement. Seeking an experienced contracts attorney to provide legal advice and leadership to the Company and to support the Law Department and individual business units with a wide range of commercial contracting matters. By using this website, you agree to our Why tocilizumab could be an effective treatment for severe COVID-19? However, the types and functions of CAFs varies in different studies or tumor types, suggesting that the functional roles of CAFs in TME is complicated and yet has not been clearly explained. 1989;86:1002410028. SARS-CoV-2 developed a global-pandemic with millions of infections/deaths. Study record managers: refer to the Data Element Definitions if submitting registration or results information. A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per standard serological and genetic testing, History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or any autoimmune disease with central nervous system (CNS) involvement.