Tests CARC-101C safety in adults with autoimmune type 1 diabetes

Trial details

Who runs it

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Trial code

NCT06546436

Record updated

9 August 2024

Original description

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.Read full original descriptionShow less

An Open, Dose-escalation Clinical Study to Evaluation of the Safety and Efficiency of a Single Dose of CARC-101C in Patients With Autoimmune Type 1 Diabetes Mellitus

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.

Inclusion: Patients are eligible to be included in this study only if all of the following criteria apply:; Males and females aged between ≥18 and ≤40 years old at the time of screening; Diagnosed with Autoimmune type 1 diabetes(T1D) within 3 to 6 months before screening, based on the 2021 version of the Chinese Guidelines for Diagnosis and Treatment of Type 1 Diabetes, with positive pancreatic autoantibodies:; Must be tested Insulin a(utoantibody)IAA-positive at the time of diagnosis; Must not have undergone any form of insulin therapy before diagnosis; Currently undergoing insulin therapy and possesses HbA1c levels between ≥7.0% and ≤12%; Possess a body mass index (BMI) between at the time of screening ≥18.0 kg/m2 and ≤ 35.0 kg/m2; Fasting C-peptide ≥0.10 nmol/L (0.30 ng/ml) or post-MMTT peak C-peptide ≥0.2 pmol/mL (0.6 ng/mL); Males and females of childbearing potential must agree to use highly effective contraception, from providing informed consent till withdrawal or 3 months post-medication (whichever occurs later); Must be capable of providing written, signed, and dated informed consent and willing to comply with research requirements in the study.

Exclusion: Diagnosed with T1D within 3 to 6 months before screening, based on the 2021 version of the Chinese Guidelines for Diagnosis and Treatment of Type 1 Diabetes, with positive pancreatic autoantibodies:; Must be tested IAA-positive at the time of diagnosis; Must not have undergone any form of insulin therapy before diagnosis; Males and females of childbearing potential must agree to use highly effective contraception, from providing informed consent till withdrawal or 3 months post-medication (whichever occurs later); Average daily total insulin use was >1.0IU/kg(international unit) per day or <15IU per day 7 days before screening; Have diabetic retinopathy stage 3 or above in addition requiring laser or surgical procedures 3 months prior to screening; Diagnosed with DKA(Diabetic Ketoacidosis) or hyperosmotic hyperglycemia syndrome 1 month before screening; Used immunosuppressants 3 months prior to screening; Used systemic glucocorticoid therapy 2 weeks prior to screening or during the study period (except for inhaled and topical glucocorticoid therapies); Participated in any drug or medical device clinical research within 3 months before screening; Previously received cell therapy; Previously reported malignant tumors (whether cured or not); HIV-Ab or HBsAg or HCV-Ab(Hepatitis C virus) or treponema pallidum positive at screening; Have a serious/uncontrolled autoimmune disease in addition to T1D at the time of screening; History of acute or chronic pancreatitis; History of hereditary bleeding tendency or coagulation dysfunction, or have a history of thrombosis, hemolysis or bleeding; Have other conditions that the investigator considers inappropriate to participate in this clinical study; Currently undergoing insulin therapy and possesses HbA1c levels between ≥7.0% and ≤12%; Any of the following abnormalities were detected in the laboratory during screening:; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 of ULN; Total bilirubin >1.5 of ULN; Hemoglobin <120g/L or > 165g/L (male), or < 110g/L or > 160g/L (female); Serum creatinine >1.5 of ULN(Upper limits of normal); Possess pre-existing diseases affecting erythrocyte production and stability, including glucose-6-phosphate dehydrogenase (G6PD) deficiency, autoimmune hemolytic anemia, paroxysmal sleep hemoglobinuria, hereditary spherocytosis, hemoglobinopathy, pyruvate kinase deficiency etc; Systemic infection, severe trauma or other states of stress confirmed by laboratory tests or clinical manifestations at the time of screening; Males and females aged between ≥18 and ≤40 years old at the time of screening; Inclusion Criteria; Patients are eligible to be included in this study only if all of the following criteria apply:; Possess a body mass index (BMI) between at the time of screening ≥18.0 kg/m2 and ≤ 35.0 kg/m2; Fasting C-peptide ≥0.10 nmol/L (0.30 ng/ml) or post-MMTT peak C-peptide ≥0.2 pmol/mL (0.6 ng/mL); Must be capable of providing written, signed, and dated informed consent and willing to comply with research requirements in the study; Patients are not eligible to be included in this study if any of the following criteria apply:; Pregnant or lactating women.

ClinicalTrials.gov NCT06546436