Autoimmune Type 1 Diabetes Mellitus(T1DM)Early Phase 1NCT06546436
The Safety and Efficiency of a Single Dose of CARC-101C in Patients With Autoimmune Type 1 Diabetes Mellitus
A Early Phase 1 study testing CARC-101C in people with Autoimmune Type 1 Diabetes Mellitus(T1DM), run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Autoimmune Type 1 Diabetes Mellitus(T1DM)
- What is being tested?
- CARC-101C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2024to 31 May 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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%.
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- 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.
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, 210008
Dalong Zhu, MD,PhD, 86-25-83-105302, zhudldr@gmail.com
Jing Lu, MD,PhD
About this study
Official title: 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.
- Being tested
- CARC-101C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARC-101CDrug
Subjects enrolled in the project will received a one-dose injection of CARC-101C
| Study group | Role | What they receive |
|---|---|---|
| Low-dose group | Active comparator | Subjects enrolled in this group will received a one-dose injection of CARC-101C, 3×1010 eRBC(engineered Red Blood Cells) in one dose. Receives: Drug: CARC-101C |
| High-dose group | Active comparator | Subjects enrolled in this group will received a one-dose injection of CARC-101C, 3×1011 eRBC in one dose. Receives: Drug: CARC-101C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events within 3 weeks after administration (NCI CTCAE V5.0).
Measured: 21 days
Secondary outcomes (20)
Changes of AUC(Area Under Curve) compared with baseline fasting and MMTT-stimulated C-peptide at 4, 12, 24, 36, 52 and 76 weeks.
Measured: 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.
Measured: 4, 12, 24, 36, 52 and 76 weeks
Percentage of subjects with HbA1c < 7% at 12, 24, 36, 52 and 76 weeks.
Measured: 12, 24, 36, 52 and 76 weeks
Diachronic change of HbA1c from baseline at 12, 24, 36, 52 and 76 weeks.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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;
Measured: 12, 24, 36, 52 and 76 weeks
Maximum concentration observed (Cmax) of CARC-101C at Day1，Day2，Day5，Day7，Day21，Week4，Week12;
Measured: 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;
Measured: 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;
Measured: 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;
Measured: Day1，Day2，Day5，Day7，Day21，Week4，Week12
Terminal phase rate constant(λz) of CARC-101C at Day1，Day2，Day5，Day7，Day21，Week4，Week12;
Measured: Day1，Day2，Day5，Day7，Day21，Week4，Week12
Terminal phase half-life (t1/2) of CARC-101C at Day1，Day2，Day5，Day7，Day21，Week4，Week12;
Measured: 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;
Measured: 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;
Measured: 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.
Measured: 76 weeks
Changes of Insulin Autoimmune Antibodies(IAA）compared with baseline at 4, 12, 24, 36, 52 and 76 weeks;
Measured: 4, 12, 24, 36, 52 and 76 weeks
Changes in cytokine levels.
Measured: 76 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start15 Aug 2024 (estimated)
- Primary completion15 Nov 2025 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune Type 1 Diabetes Mellitus(T1DM)Studies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Carcell Biopharma Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546436
- Sponsor's protocol ID
- KMX-CARC-101C-IIT01
- Status last verified
- Jun 2024
- First submitted
- 14 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06546436
- Acronym / sponsor ID
- KMX-CARC-101C-IIT01
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Collaborators
- Carcell Biopharma Ltd.
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-dose group | Active comparator | Drug: CARC-101CSubjects enrolled in this group will received a one-dose injection of CARC-101C, 3×1010 eRBC(engineered Red Blood Cells) in one dose. |
| High-dose group | Active comparator | Drug: CARC-101CSubjects enrolled in this group will received a one-dose injection of CARC-101C, 3×1011 eRBC in one dose. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Patients are eligible to be included in this study only if all of the following criteria apply:
- 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:
- Currently undergoing insulin therapy and possesses HbA1c levels between ≥7.0% and ≤12%.
Key exclusion criteria (22 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CARC-101CSubjects enrolled in the project will received a one-dose injection of CARC-101C | Drug | High-dose group, Low-dose group |
Primary outcome
Incidence and severity of adverse events within 3 weeks after administration (NCI CTCAE V5.0).
Time frame: 21 days
20 secondary outcomes
Changes of AUC(Area Under Curve) compared with baseline fasting and MMTT-stimulated C-peptide at 4, 12, 24, 36, 52 and 76 weeks.
Time frame: 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.
Time frame: 4, 12, 24, 36, 52 and 76 weeks
Percentage of subjects with HbA1c < 7% at 12, 24, 36, 52 and 76 weeks.
Time frame: 12, 24, 36, 52 and 76 weeks
Diachronic change of HbA1c from baseline at 12, 24, 36, 52 and 76 weeks.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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;
Time frame: 12, 24, 36, 52 and 76 weeks
Maximum concentration observed (Cmax) of CARC-101C at Day1，Day2，Day5，Day7，Day21，Week4，Week12;
Time frame: 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;
Time frame: 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;
Time frame: 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;
Time frame: Day1，Day2，Day5，Day7，Day21，Week4，Week12
Terminal phase rate constant(λz) of CARC-101C at Day1，Day2，Day5，Day7，Day21，Week4，Week12;
Time frame: Day1，Day2，Day5，Day7，Day21，Week4，Week12
Terminal phase half-life (t1/2) of CARC-101C at Day1，Day2，Day5，Day7，Day21，Week4，Week12;
Time frame: 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;
Time frame: 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;
Time frame: 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.
Time frame: 76 weeks
Changes of Insulin Autoimmune Antibodies(IAA）compared with baseline at 4, 12, 24, 36, 52 and 76 weeks;
Time frame: 4, 12, 24, 36, 52 and 76 weeks
Changes in cytokine levels.
Time frame: 76 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CARC-101C in people with Autoimmune Type 1 Diabetes Mellitus(T1DM), run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events within 3 weeks after administration (NCI CTCAE V5.0). (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.