[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"GentiBio, Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":64},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100582223","hla-demographics-study-in-adults-with-type-1-diabetes-100582223",false,"NCT06860516","HLA Demographics Study in Adults With Type 1 Diabetes","A Non-interventional Study of HLA-DRB1*04:01 Distribution in Adults With Recently Diagnosed Type 1 Diabetes (T1D)","Inclusion Criteria:\n\n1. Male and female participants aged ≥ 18 to ≤ 55 years, with type 1 DM meeting American Diabetes Association criteria at diagnosis:\n\n   1. Fasting glucose ≥ 126 mg\u002FdL (7.0 mmol\u002FL), or\n   2. 2-hour oral glucose tolerance test plasma glucose ≥ 200 mg\u002FdL (11.0 mmol\u002FL), or\n   3. Hemoglobin A1c ≥ 6.5%, or\n   4. Random plasma glucose ≥ 200 mg\u002FdL (11.1 mmol\u002FL) (with documented classic hyperglycemia symptoms or hyperglycemic crisis).\n2. Date of T1D diagnosis within 6 months of the study visit.\n3. Able and willing to provide written, informed consent as approved by the institutional review board (IRB). Participants must be able to consent directly; no other person or guardian may consent for them in this study.\n\nExclusion Criteria:\n\n1. Participant is an employee of, or an immediate family member of an employee, of the Sponsor, study site, or of a contractor\u002Fvendor who is involved in direct study conduct for this protocol.\n2. Participant is unwilling or unable to comply with the study visit assessments.","ALL","18 Years","55 Years",{"count":20,"type":21},200,"ESTIMATED","OBSERVATIONAL","This is a study to evaluate the HLA-DRB1\\*04:01 genotype in adults that have been diagnosed with type 1 diabetes",[25],"Diabetes Mellitus, Type I","RECRUITING","2026-04-30",{"date":29,"type":30},"2026-05-06","ACTUAL",{"date":32,"type":30},"2025-06-06",{"date":34,"type":21},"2027-03",{"name":36,"class":37},"GentiBio, Inc","INDUSTRY",5,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100586744","phase-1-a-study-of-gnti-122-in-adults-recently-diagnosed-with-t1d-100586744","NCT06919354","A Study of GNTI-122 in Adults Recently Diagnosed With T1D","POLARIS: A Phase 1, Single Dose, Open-label Study of GNTI-122 in Adults With Recently Diagnosed Type 1 Diabetes (T1D)","POLARIS","Inclusion Criteria:\n\n1. Male and female participants aged ≥18 to ≤55 years with recently diagnosed (within 180 days of Screening) T1D according to American Diabetes Association criteria.\n2. Participant has residual β-cell function during Screening, defined as random C-peptide ≥ 0.2 nmol\u002FL.\n3. Positive for at least one T1D-associated autoantibody.\n4. Able and willing to provide written, informed consent as approved by the IRB.\n5. Is confirmed positive for the HLA-DRB1\\*04:01 allele.\n6. Has adequate vascular access to undergo leukapheresis with no known contraindications.\n\n8\\. Female participants of childbearing potential must have a negative serum pregnancy test at Screening, must be not lactating, and must agree to protocol-specified contraception.\n\n9\\. Male participants of childbearing potential must agree to protocol specified contraception.\n\n10\\. Other than T1D, participant is in good general health.\n\nExclusion Criteria:\n\n1. Type 2 diabetes.\n2. Experienced DKA within 4 weeks prior to or during Screening.\n3. Unwilling or unable to comply with study procedures or schedule.\n4. Chronic or uncontrolled medical condition.\n5. Has another active or autoimmune or inflammatory disease with the exception of well-controlled Hashimoto's thyroiditis, celiac disease, or vitiligo.\n6. Participation in another clinical study or active follow-up in a prior study.",{"count":48,"type":21},16,"INTERVENTIONAL",[51],"PHASE1","This is a 78-week single arm, multi-center, Phase 1 study to evaluate the safety, tolerability, cellular kinetics, and biomarker changes in C-peptide over time of GNTI-122, an investigational cell therapy manufactured from a participant's own blood cells in adult participants with recently diagnosed T1D. After assessment of eligibility, participants who qualify for the study will be enrolled sequentially in 1 of 3 cohorts. Cohort 1 participants (n=3) receive a low dose of GNTI-122 . Cohort 2 participants (n=3) receive a high dose of GNTI-122. Cohort 3 participants (n=10) receive a high dose of GNTI-122 in combination with rapamycin. Participants are followed for 78 weeks after the administration of GNTI-122 during which safety and efficacy assessments are made, including vital signs, ECG, physical exam, clinical labs, and monitoring of adverse events and concomitant medications. Disease markers (e.g., MMTT-stimulated C-peptide, HbA1c) and pharmacodynamic activity (e.g., lymphocyte subsets and phenotypes, effector T cell responses to islet antigens ex vivo, T1D autoantibodies) will be monitored serially throughout the study. The study will include sentinel dosing and a Safety Review Committee to ensure participant safety. Visit https:\u002F\u002Fwww.polarisstudy.com to learn more!",[54,55],"Type 1 Diabetes (T1D)","Type 1 Diabetes Mellitus",{"date":57,"type":30},"2026-05-04",{"date":59,"type":30},"2025-09-03",{"date":61,"type":21},"2028-02",{"name":36,"class":37},10,""]