Status:
NOT_YET_RECRUITING
The Safety and Efficiency of a Single Dose of CARC-101C in Patients With Autoimmune Type 1 Diabetes Mellitus
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborating Sponsors:
Carcell Biopharma Ltd.
Conditions:
Autoimmune Type 1 Diabetes Mellitus(T1DM)
Eligibility:
All Genders
18-40 years
Phase:
EARLY_PHASE1
Brief 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 us...
Eligibility Criteria
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
- Inclusion Criteria
- 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 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.
- 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 Criteria
- Patients are not eligible to be included in this study if any of the following criteria apply:
- Average daily total insulin use was \>1.0IU/kg(international unit) per day or \<15IU per day 7 days before screening.
- 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).
- 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.
- Have diabetic retinopathy stage 3 or above in addition requiring laser or surgical procedures 3 months prior to screening.
- 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.
- History of acute or chronic pancreatitis.
- History of hereditary bleeding tendency or coagulation dysfunction, or have a history of thrombosis, hemolysis or bleeding.
- 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).
- Systemic infection, severe trauma or other states of stress confirmed by laboratory tests or clinical manifestations at the time of screening.
- Pregnant or lactating women.
- Have other conditions that the investigator considers inappropriate to participate in this clinical study.
Key Trial Info
Start Date :
August 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06546436
Start Date
August 15 2024
End Date
May 31 2027
Last Update
August 9 2024
Active Locations (1)
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1
Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, China, 210008