2025
Latent EBV enhances the efficacy of anti-CD3 mAb in Type 1 diabetes
Lledó-Delgado A, Preston-Hurlburt P, Higdon L, Hu A, James E, Lim N, Long S, McNamara J, Nguyen H, Serti E, Sumida T, Herold K. Latent EBV enhances the efficacy of anti-CD3 mAb in Type 1 diabetes. Nature Communications 2025, 16: 5033. PMID: 40447640, PMCID: PMC12125364, DOI: 10.1038/s41467-025-60276-5.Peer-Reviewed Original ResearchConceptsCD8+ T cellsEBV-seropositive individualsType 1 diabetesT cellsImmune cellsAntigen-specific CD8+ T cellsDiagnosis of type 1 diabetesEBV-seronegative patientsEBV-seropositive patientsT cell activation pathwaysRegulatory T cellsAnti-CD3 mAbInnate immune cellsPeripheral blood cellsT cell receptorProgression of diseaseContext of type 1 diabetesImpaired signaling pathwaysTeplizumabClinical trialsLatent EBVBlood cellsSingle cell transcriptomicsModulate progressionMTOR signaling
2024
Evolving Concepts in Pathophysiology, Screening, and Prevention of Type 1 Diabetes: Report of Diabetes Mellitus Interagency Coordinating Committee Workshop.
Greenbaum C, Nepom G, Wood-Heickman L, Wherrett D, DiMeglio L, Herold K, Krischer J. Evolving Concepts in Pathophysiology, Screening, and Prevention of Type 1 Diabetes: Report of Diabetes Mellitus Interagency Coordinating Committee Workshop. Diabetes 2024, 73: 1780-1790. PMID: 39167668, PMCID: PMC11493760, DOI: 10.2337/dbi24-0020.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, Monoclonal, HumanizedDiabetes Mellitus, Type 1HumansMass ScreeningUnited StatesConceptsType 1 diabetesClinical trialsType 1 Diabetes TrialNetEtiology of type 1 diabetesImmune Tolerance NetworkFood and Drug AdministrationU.S. Food and Drug AdministrationNational Institute of DiabetesDigestive and Kidney DiseasesMultiple immune pathwaysDisease-modifying therapiesMechanism of actionTherapeutic responsePrognostic markerKidney diseaseDrug AdministrationTrialNetClinical diagnosisImmune pathwaysDiabetesTeplizumabRegulatory approvalClinical carePathophysiologyDisease
2023
Teplizumab and β-Cell Function in Newly Diagnosed Type 1 Diabetes
Ramos E, Dayan C, Chatenoud L, Sumnik Z, Simmons K, Szypowska A, Gitelman S, Knecht L, Niemoeller E, Tian W, Herold K. Teplizumab and β-Cell Function in Newly Diagnosed Type 1 Diabetes. New England Journal Of Medicine 2023, 389: 2151-2161. PMID: 37861217, DOI: 10.1056/nejmoa2308743.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAntibodies, Monoclonal, HumanizedC-PeptideCD3 ComplexChildDiabetes Mellitus, Type 1Disease ProgressionDouble-Blind MethodHumansHypoglycemic AgentsInsulinInsulin-Secreting CellsT-LymphocytesConceptsC-peptide levelsB cell functionDiagnosed type 1 diabetesType 1 diabetesSecondary end pointsEnd pointsMild cytokine release syndromePeak C-peptide levelsMonoclonal antibodies to CD3Stimulated C-peptide levelsNewly diagnosed type 1 diabetesClinical type 1 diabetesCytokine release syndromePatients 8 yearsPlacebo-controlled trialPrimary end pointAntibodies to CD3Clinical end pointsAssociated with administrationPrevent disease progressionGlycated hemoglobin levelsFood and Drug AdministrationTarget glucose rangeT cellsTeplizumab
2019
An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes
Herold KC, Bundy BN, Long SA, Bluestone JA, DiMeglio LA, Dufort MJ, Gitelman SE, Gottlieb PA, Krischer JP, Linsley PS, Marks JB, Moore W, Moran A, Rodriguez H, Russell WE, Schatz D, Skyler JS, Tsalikian E, Wherrett DK, Ziegler AG, Greenbaum CJ. An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes. New England Journal Of Medicine 2019, 381: 603-613. PMID: 31180194, PMCID: PMC6776880, DOI: 10.1056/nejmoa1902226.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAntibodies, Monoclonal, HumanizedCD3 ComplexChildDiabetes Mellitus, Type 1Disease ProgressionDouble-Blind MethodExanthemaFemaleGlucose Tolerance TestHLA-DR3 AntigenHLA-DR4 AntigenHumansLymphocyte CountLymphopeniaMaleMiddle AgedProportional Hazards ModelsT-LymphocytesYoung AdultConceptsType 1 diabetesClinical type 1 diabetesTeplizumab groupPlacebo groupOral glucose tolerance testInsulin-producing beta cellsDouble-blind trialChronic autoimmune diseaseGlucose tolerance testRelatives of patientsRate of diagnosisHigh-risk participantsTransient lymphopeniaAdverse eventsHazard ratioHLA-DR3HLA-DR4Median timeClinical progressionAutoimmune diseasesExogenous insulinCD3 antibodyT cellsTeplizumabClinical disease
2012
Teplizumab Induces Human Gut-Tropic Regulatory Cells in Humanized Mice and Patients
Waldron-Lynch F, Henegariu O, Deng S, Preston-Hurlburt P, Tooley J, Flavell R, Herold KC. Teplizumab Induces Human Gut-Tropic Regulatory Cells in Humanized Mice and Patients. Science Translational Medicine 2012, 4: 118ra12. PMID: 22277969, PMCID: PMC4131554, DOI: 10.1126/scitranslmed.3003401.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsAntibodies, Monoclonal, HumanizedCD3 ComplexCell MovementDiabetes Mellitus, Type 1Forkhead Transcription FactorsGastrointestinal TractHumansHypoglycemic AgentsInterleukin-10Intestine, SmallL-SelectinMiceMucous MembraneNatalizumabOligonucleotide Array Sequence AnalysisReceptors, CCR6T-Lymphocytes, RegulatoryConceptsHumanized micePeripheral circulationSmall intestineType 1 diabetes mellitusNovel immunologic mechanismIL-10 expressionTreatment of patientsType 1 diabetesSecondary lymph organsHuman immune cellsT cell migrationMechanism of actionGut-tropicImmunologic mechanismsRegulatory cellsDiabetes mellitusImmune therapyInterleukin-10Immune cellsRegulatory cytokinesClinical trialsPreclinical modelsClinical studiesT cellsHuman hematopoietic stem cells
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