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

NCT ID: NCT06546436

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-15
• Study Completion Date: 2027-05-31

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 used.

Conditions

Autoimmune Type 1 Diabetes Mellitus(T1DM)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Low-dose group

Subjects enrolled in this group will received a one-dose injection of CARC-101C, 3×1010 eRBC(engineered Red Blood Cells) in one dose.

Group Type: ACTIVE_COMPARATOR

CARC-101C

Intervention Type: DRUG

Subjects enrolled in the project will received a one-dose injection of CARC-101C

High-dose group

Subjects enrolled in this group will received a one-dose injection of CARC-101C, 3×1011 eRBC in one dose.

Group Type: ACTIVE_COMPARATOR

CARC-101C

Intervention Type: DRUG

Subjects enrolled in the project will received a one-dose injection of CARC-101C

Interventions

CARC-101C

Subjects enrolled in the project will received a one-dose injection of CARC-101C

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients are eligible to be included in this study only if all of the following criteria apply:

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

2. 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:

1. Must be tested Insulin a(utoantibody)IAA-positive at the time of diagnosis.

2. Must not have undergone any form of insulin therapy before diagnosis.

3. Currently undergoing insulin therapy and possesses HbA1c levels between ≥7.0% and ≤12%.

4. Possess a body mass index (BMI) between at the time of screening ≥18.0 kg/m2 and ≤ 35.0 kg/m2.

5. 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).

6. 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).

7. Must be capable of providing written, signed, and dated informed consent and willing to comply with research requirements in the study.

Patients are eligible to be included in this study only if all of the following criteria apply:

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

2. 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:

1. Must be tested IAA-positive at the time of diagnosis.

2. Must not have undergone any form of insulin therapy before diagnosis.

3. Currently undergoing insulin therapy and possesses HbA1c levels between ≥7.0% and ≤12%.

4. Possess a body mass index (BMI) between at the time of screening ≥18.0 kg/m2 and ≤ 35.0 kg/m2.

5. 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).

6. 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).

7. 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:

1. Average daily total insulin use was >1.0IU/kg(international unit) per day or <15IU per day 7 days before screening.

2. Any of the following abnormalities were detected in the laboratory during screening:

1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 of ULN

2. Total bilirubin >1.5 of ULN

3. Hemoglobin <120g/L or > 165g/L (male), or < 110g/L or > 160g/L (female).

4. Serum creatinine >1.5 of ULN(Upper limits of normal).

3. HIV-Ab or HBsAg or HCV-Ab(Hepatitis C virus) or treponema pallidum positive at screening

4. Have a serious/uncontrolled autoimmune disease in addition to T1D at the time of screening.

5. Have diabetic retinopathy stage 3 or above in addition requiring laser or surgical procedures 3 months prior to screening.

6. 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.

7. History of acute or chronic pancreatitis.

8. History of hereditary bleeding tendency or coagulation dysfunction, or have a history of thrombosis, hemolysis or bleeding.

9. Diagnosed with DKA(Diabetic Ketoacidosis) or hyperosmotic hyperglycemia syndrome 1 month before screening.

10. Used immunosuppressants 3 months prior to screening.

11. Used systemic glucocorticoid therapy 2 weeks prior to screening or during the study period (except for inhaled and topical glucocorticoid therapies).

12. Participated in any drug or medical device clinical research within 3 months before screening.

13. Previously received cell therapy.

14. Previously reported malignant tumors (whether cured or not).

15. Systemic infection, severe trauma or other states of stress confirmed by laboratory tests or clinical manifestations at the time of screening.

16. Pregnant or lactating women.

17. Have other conditions that the investigator considers inappropriate to participate in this clinical study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carcell Biopharma Ltd.

UNKNOWN

Sponsor Role: collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University

Nanjing, Jiangsu, China

Countries

China

Facility Contacts

Dalong Zhu, MD,PhD

Role: primary

zhudldr@gmail.com

86-25-83-105302

Other Identifiers

KMX-CARC-101C-IIT01

Identifier Type: -

Identifier Source: org_study_id