The Safety and Efficiency of a Single Dose of CARC-101C in Patients With Autoimmune Type 1 Diabetes Mellitus
NCT Number: NCT06546436
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Autoimmune Type 1 Diabetes Mellitus(T1DM)
Interventions: DRUG: CARC-101C
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborators: Carcell Biopharma Ltd.
Sex: ALL
Age: ADULT
Enrollment: 12
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08-15
Completion Date: 2027-05-31
Locations: Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University, Nanjing, Jiangsu, 210008, China

Summary:
This study investigated the safety, efficiency, pharmacokinetics and pharmacokinetics of CARC-101C in patients with autoimmune type 1 diabetes. A single dose, dose escalation, open study design was used.

Primary Outcome Measures: Incidence and severity of adverse events within 3 weeks after administration (NCI CTCAE V5.0)., 21 days
Secondary Outcome Measures: 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