The Safety and Efficiency of a Single Dose of CARC-101C in Patients With Autoimmune Type 1 Diabetes Mellitus

Prior treatment

• 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).

Other illness

• 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.

Lab values

• 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.

Age

• Males and females aged between ≥18 and ≤40 years old at the time of screening.

Other

• 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.

• 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.