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Clinical Trial Details

Trial ID: L4580
Source ID: NCT06546436
Associated Drug: Carc-101c
Title: The Safety and Efficiency of a Single Dose of CARC-101C in Patients With Autoimmune Type 1 Diabetes Mellitus
Acronym:
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Autoimmune Type 1 Diabetes Mellitus(T1DM)
Interventions: DRUG: CARC-101C
Outcome Measures: Primary: Incidence and severity of adverse events within 3 weeks after administration (NCI CTCAE V5.0)., 21 days | Secondary: Changes of AUC(Area Under Curve) compared with baseline fasting and MMTT-stimulated C-peptide at 4, 12, 24, 36, 52 and 76 weeks., 4, 12, 24, 36, 52 and 76 weeks|Changes of C-peptide compared with baseline in fasting and 2h after MMTT(Mixed-meal tolerance test)-stimulated at 4, 12, 24, 36, 52 and 76 weeks., 4, 12, 24, 36, 52 and 76 weeks|Percentage of subjects with HbA1c < 7% at 12, 24, 36, 52 and 76 weeks., 12, 24, 36, 52 and 76 weeks|Diachronic change of HbA1c from baseline at 12, 24, 36, 52 and 76 weeks., 12, 24, 36, 52 and 76 weeks|Percentage of subjects whose weekly mean insulin requirement decreased by 50% or more at 4, 12, 24, 36, 52 and 76 weeks., 4, 12, 24, 36, 52 and 76 weeks|Diachronic change in weekly mean insulin requirement from baseline at 4, 12, 24, 36, 52 and 76 weeks., 4, 12, 24, 36, 52 and 76 weeks|Homeostatic model assessment of β-cell function (HOMA-β) from baseline at 4, 12, 24, 36, 52 and 76 weeks., 4, 12, 24, 36, 52 and 76 weeks|Time in Range (TIR, time of glucose readings at 3.9 to 10.0 mmol/L) changes from baseline in indicators associated with continuous glucose monitoring at 12, 24, 36, 52 and 76 weeks., 12, 24, 36, 52 and 76 weeks|Percentage of subjects with TIR >70% from baseline by continuous glucose monitors compared with baseline at 12, 24, 36, 52 and 76 weeks;, 12, 24, 36, 52 and 76 weeks|Maximum concentration observed (Cmax) of CARC-101C at Day1,Day2,Day5,Day7,Day21,Week4,Week12;, Day1,Day2,Day5,Day7,Day21,Week4,Week12|Time at which the maximum concentration (Tmax ) of CARC-101C at Day1,Day2,Day5,Day7,Day21,Week4,Week12;, Day1,Day2,Day5,Day7,Day21,Week4,Week12|AUC up to the last measurable concentratio(AUC (0-t)): of CARC-101C at Day1,Day2,Day5,Day7,Day21,Week4,Week12;, Day1,Day2,Day5,Day7,Day21,Week4,Week12|AUC curve to infinite time(AUC (0--∞)) of CARC-101C at Day1,Day2,Day5,Day7,Day21,Week4,Week12;, Day1,Day2,Day5,Day7,Day21,Week4,Week12|Terminal phase rate constant(λz) of CARC-101C at Day1,Day2,Day5,Day7,Day21,Week4,Week12;, Day1,Day2,Day5,Day7,Day21,Week4,Week12|Terminal phase half-life (t1/2) of CARC-101C at Day1,Day2,Day5,Day7,Day21,Week4,Week12;, Day1,Day2,Day5,Day7,Day21,Week4,Week12|Changes of the T cell subpopulation compared with baseline at 3, 4, 12, 24, 36, 52 and 76 weeks;, 3, 4, 12, 24, 36, 52 and 76 weeks|Changes of the presence of pathogenicity related T cells compared with baseline at 3, 4, 12, 24, 36, 52 and 76 weeks;, 3, 4, 12, 24, 36, 52 and 76 weeks|Incidence and severity of adverse events within 76 weeks after administration according to version 5.0 of NCI CTCAE., 76 weeks|Changes of Insulin Autoimmune Antibodies(IAA)compared with baseline at 4, 12, 24, 36, 52 and 76 weeks;, 4, 12, 24, 36, 52 and 76 weeks|Changes in cytokine levels., 76 weeks
Sponsor/Collaborators: Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Collaborators: Carcell Biopharma Ltd.
Gender: ALL
Age: ADULT
Phases: EARLY_PHASE1
Enrollment: 12
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08-15
Completion Date: 2027-05-31
Results First Posted:
Last Update Posted: 2024-08-09
Locations: Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University, Nanjing, Jiangsu, 210008, China
URL: https://clinicaltrials.gov/show/NCT06546436