protocolSection identificationModule nctId: NCT06305286, orgStudyIdInfo id: IRB23-1367, briefTitle: Safety, Tolerability, and Efficacy of Immunomodulation With A Monoclonal Antibody Against CD40L in Combination With Transplanted Islet Cells in Adults With Brittle Type 1 Diabetes Mellitus (T1D), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2029-03, completionDateStruct date: 2029-03, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: University of Chicago, class: OTHER, collaborators name: Juvenile Diabetes Research Foundation, collaborators name: Cure Alliance, descriptionModule briefSummary: AT-1501 is a monoclonal antibody. Antibodies are Y-shaped proteins that are produced naturally by the subject's immune system to attack and fight foreign substances that cause illness. Monoclonal antibodies are man-made proteins manufactured to serve as substitute antibodies to fight diseases. Monoclonal antibodies can restore, enhance, or mimic (copy) the immune system's attack process; they can also tone down the immune system. AT-1501 is thought to work by dampening down the immune system so that it will be less likely to attack the transplanted cells. For other types of transplants, like kidney, a drug called a calcineurin inhibitor is usually used to prevent rejection. That class of drugs can be toxic to islet cells. AT-1501 is an experimental agent that is anticipated to prevent rejection without harming the islet cells., conditionsModule conditions: Diabetes Mellitus, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 3, type: ESTIMATED, armsInterventionsModule interventions name: AT-1501, outcomesModule primaryOutcomes measure: Number of Participants who are insulin-independent post- first and final transplant, secondaryOutcomes measure: Number of Participants with glycosylated hemoglobin (HbA1c) <7.0%, otherOutcomes measure: Number of Participants with free of serious hypoglycemic events (SHEs) post-first and final transplant, otherOutcomes measure: Number of Participants with HbA1c ≤6.5% AND free from SHEs post-first and final transplant., otherOutcomes measure: Number of Participants with graft failure post final transplant., otherOutcomes measure: Number of participants with impaired awareness of hypoglycemia after final islet cell transplant and after discontinuation of AT-1501., otherOutcomes measure: Change in glycemic lability after final islet cell transplant and years after discontinuation of AT-1501, otherOutcomes measure: Change in albumin excretion ratio (AER) post-first and final transplant., otherOutcomes measure: Change in estimated glomerular filtration rate (eGFR) post-first and final transplant., otherOutcomes measure: Change in percent new macroalbuminuria post-first and final transplant., otherOutcomes measure: Change in variability after final islet cell transplant and years after discontinuation of AT-1501, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Chicago, status: RECRUITING, city: Chicago, state: Illinois, zip: 60637, country: United States, contacts name: Piotr Witkowski, MD PhD, role: CONTACT, phone: 773-702-2447, email: pwitkowski@surgery.bs.uchicago.edu, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False