Type 1 Diabetes (T1D)CNK-UT009NCT07051564
Clinical Study on the Treatment of Type 1 Diabetes With CNK-UT009 Cell Injection
A study testing CNK-UT009 cell injection in people with Type 1 Diabetes (T1D), run by Zibo Central Hospital at 1 site in China.
Trial summary
This is a single-arm, open, investigator-initiated clinical study of CNK-UT009 cell injection in patients with type 1 diabetes. The purpose of this study is to evaluate the safety and tolerability of CNK-UT009 cell injection in patients with type 1 diabetes mellitus, determine the maximum tolerated dose (MTD), and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes (T1D)
- What is being tested?
- CNK-UT009 cell injection
- 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
- 6 May 2025to 31 Dec 2026
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who meet all of the following criteria can be considered for inclusion:
- Age 18 to 65 years old (including the cut-off value), gender not limited;
- Diagnosed with autoimmune type 1 diabetes (meeting the diagnostic criteria of the "Chinese Guidelines for the Diagnosis and Treatment of Type 1 Diabetes (2021 Edition)"), and the peak C-peptide was ≥0.2nmol/L after 2-hour mixed meal (MMTT) stimulation during the screening period;
- At least one insulin autoantibody is positive, such as glutamate decarboxylase autoantibody (GADA), protein tyrosine phosphatase autoantibody (IA-2A), insulin autoantibody (IAA) (without insulin use or within 2 weeks of insulin treatment), zinc transporter antibody (ZnT8A);
- Glycated hemoglobin (HbA1c) ≥6.5% and ≤10.5%;
- Body mass Index (BMI)≥18kg/m ² and ≤35kg/m ²;
Show all 11Show fewer
- Have sufficient organ and bone marrow functions, and the laboratory test values within 7 days before enrollment meet the following requirements, as detailed below:
- Blood routine: Absolute neutrophil count (ANC) ≥1.0× 109 /L; Absolute lymphocyte count (LYC) ≥1.0× 109 /L; Platelet count (PLT) ≥75×109/L; Hemoglobin content (HGB) ≥80g/L; Heart: Left ventricular ejection fraction (LVEF) ≥50%; Cardiac function grade 1-2 Lung function: Indoor blood oxygen saturation ≥92%; Liver function: Serum total bilirubin (TBIL) ≤1.5×ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN; Renal function: Serum creatinine (Cr) ≤1.5×ULN; Glomerular filtration rate (eGFR) ≥60mL/min/1.73m2 (calculated by the MDRD formula)
- For female patients of childbearing age, the serum or urine pregnancy result must be negative before enrollment, and they must agree to take acceptable measures to minimize the possibility of pregnancy during the trial. Female patients of childbearing age or male patients whose sexual partners are female patients of childbearing age need to take effective contraceptive measures throughout the treatment period and 6 months after the last medication.
- Agree to abide by the principles and suggestions of medical nutrition therapy in the "Chinese Guidelines for the Diagnosis and Treatment of Type 1 Diabetes Mellitus (2021 Edition)";
- Voluntarily participate in clinical research, understand and be informed of this study, sign the informed consent form, and be willing to follow all trial procedures.
Who cannot join
- Patients meeting any of the following criteria are not eligible for enrollment:
- Active malignant tumors requiring treatment, except for non-melanoma skin cancer or carcinoma in situ (such as breast, cervical);
- Subjects who have received organ transplants in the past or are preparing to receive organ transplants;
- Those who have received immunosuppressant treatment within 4 weeks before enrollment and/or require long-term immunosuppressive treatment during the study period, and are allowed to use topical, inhaled or intranasal corticosteroids intermittently;
- Any life-threatening bleeding events occurred within 3 months before enrollment, including the need for blood transfusion treatment, surgery or local treatment, and continuous drug treatment;
- A history of arterial or venous thromboembolic events within 6 months before enrollment, including myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or any other serious thromboembolic events. Thrombosis derived from implantable venous infusion ports or catheters, or superficial venous thrombosis, is excluded if the thrombus is stable after conventional anticoagulant therapy. Prophylactic use of small doses of low-molecular-weight heparin (such as enoxaparin 40 mg/ day) is permitted;
Show all 29Show fewer
- Severe bleeding tendency or coagulation dysfunction, or currently undergoing thrombolytic therapy;
- Uncontrollable hypertension, with a systolic blood pressure greater than 160 mmHg or a diastolic blood pressure greater than 100 after the best medical treatment mmHg, history of hypertensive crisis or hypertensive encephalopathy;
- Symptomatic congestive heart failure (New York Heart Association Classification II-IV). Symptomatic or poorly controlled arrhythmias. A history of congenital long QT syndrome or corrected QTc>500 ms during screening;
- Pulmonary diseases such as a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, and severe impairment of lung function;
- Active pulmonary tuberculosis (TB), those who are currently undergoing anti-tuberculosis treatment or have received anti-tuberculosis treatment within one year prior to the first administration of medication; Active hepatitis B and C virus carriers, human immunodeficiency virus carriers, and known syphilis carriers;
- There was a severe infection in the active stage or with poor clinical control within 4 weeks before enrollment, including but not limited to hospitalization due to infection, bacteremia or severe pneumonia complications;
- Complications of diabetes, such as:
- Ketoacidosis
- Renal insufficiency (urine protein ≥2+, eGFR<60mL/min/1.73m2);
- Active or untreated proliferative retinopathy;
- Diabetic foot ulcer
- Amputation caused by diabetes;
- Severe peripheral neuropathy.
- Have received any non-insulin hypoglycemic drugs or drugs that affect glucose metabolism within 4 weeks or 5 half-lives (of the drug) before enrollment, whichever is shorter.
- Two or more severe and unexplained hypoglycemic events occurred within 6 months before enrollment;
- A history of inability to complete the mixed meal tolerance test (MMTT), or a significant allergic reaction (such as anaphylactic shock) to any component in the mixed meal of the MMTT test;
- Received treatment from other clinical studies within 4 weeks before enrollment;
- Those who have received attenuated live vaccines within 4 weeks before enrollment;
- Those who have used any gene therapy products in the past;
- It is known to be allergic to any component of CNK-UT009 cell injection;
- Suffering from a known mental illness or substance abuse disorder, and these disorders may interfere with the subject's ability to cooperate with the research requirements;
- Subjects whose researchers consider to have other life-threatening serious complications that may potentially or interfere with the assessment of this study;
- Other circumstances that the researcher deems inappropriate to participate in the 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, 1 recruiting
- Recruiting
Zibo Central hospital
Zibo, Shandong, 255400
Xiaoming Pang, Doctor, +86-5332361126, pxm@sdu.edu.cn
Xiaoming Pang, Doctor
About this study
Official title: A Clinical Study to Evaluate the Safety, Initial Efficacy and Pharmacokinetics of a Generic CNK-UT009 Cell Injection for the Treatment of Type 1 Diabetes Mellitus
This is a single-arm, open, investigator-initiated clinical study of CNK-UT009 cell injection in patients with type 1 diabetes. The purpose of this study is to evaluate the safety and tolerability of CNK-UT009 cell injection in patients with type 1 diabetes mellitus, determine the maximum tolerated dose (MTD), and evaluate the initial therapeutic effectiveness, PK characteristics and immunogenicity of CNK-UT009 cell injection. And the effect of CNK-UT009 cell injection on peripheral blood immune cells and serum cytokines.
Read the detailed description
The primary objective of this study is to evaluate the safety and tolerability of CNK-UT009 cell injection in the treatment of patients with type 1 diabetes and to determine the maximum tolerated dose (MTD).
Secondary objectives include:
- Assessing the preliminary efficacy of CNK-UT009 cell injection in treating patients with type 1 diabetes;
- Evaluating the pharmacokinetic (PK) characteristics of CNK-UT009 cell injection;
- Assessing the impact of CNK-UT009 cell injection reinfusion on peripheral blood immune cells;
- Assessing the impact of CNK-UT009 cell injection reinfusion on serum cytokines;
- Evaluating the immunogenicity of CNK-UT009 cell injection.
The primary endpoints of this clinical trial are:
- Safety and tolerability endpoints: Adverse events occurring after the reinfusion of CNK-UT009 cell injection, including the type, frequency, and severity of treatment-emergent adverse events (TEAEs), to determine the maximum dose-limiting toxicity (DLT) and tolerated dose (MTD);
- Primary efficacy endpoint: Changes in serum C-peptide peak and area under the curve (AUC) after a 2-hour mixed meal tolerance test (MMTT) before and after the reinfusion of CNK-UT009 cell injection.
Secondary research endpoints are:
- Secondary efficacy endpoints: Changes in the percentage of glycated hemoglobin (HbA1c) before and after the reinfusion of CNK-UT009 cell injection;
- Before and after the reinfusion of CNK-UT009 cell injection, the patient wore a continuous glucose monitoring system (CGM), measuring average glucose levels, time in range (TIR), time above range (TAR), and changes in time below range (TBR);
- Changes in the average daily insulin dosage within 7 days before and after the reinfusion of CNK-UT009 cell injection;
- Changes in the titer of islet autoantibodies before and after the reinfusion of CNK-UT009 cell injection.
Pharmacokinetics (PK): Changes in the number of CAR-positive cells in peripheral blood before and after the reinfusion of CNK-UT009 cell injection, and the dynamic changes in DNA copy number of T cells.
Peripheral blood immune cells: Subtypes of immune cells in peripheral blood before and after the reinfusion of CNK-UT009 cell injection, including but not limited to NKG2D-L (MICA/B, ULBP1/2/3/5/6) + T cells, B cells, and changes in the percentage of Treg cells.
Serum cytokines: Changes in serum cytokines (including IL2) before and after the reinfusion of CNK-UT009 cell injection, including IL6, IL10, IFN-γ, TNF-α, etc.
Immunogenicity: The binding ratio of CNK-UT009 cell injection to serum antibodies (IgG) in the subjects and the rate of change.
- Conditions
- Type 1 Diabetes (T1D)
- Being tested
- CNK-UT009 cell injection
- Keywords
- Type 1 diabetes, CNK-UT009
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNK-UT009 cell injectionBiological
CNK-UT009 cell injection
| Study group | Role | What they receive |
|---|---|---|
| This is a single-arm, open, investigator-initiated clinical study of CNK-UT009 cell injection in pat | Experimental | This is a single-arm, open, investigator-initiated clinical study of CNK-UT009 cell injection in patients with type 1 diabetes. The purpose of this study is to evaluate the safety and tolerability of CNK-UT009 cell injection in patients with type 1 diabetes mellitus, determine the maximum tolerated dose (MTD), and evaluate the initial therapeutic effectiveness, PK characteristics and immunogenicity of CNK-UT009 cell injection. And the effect of CNK-UT009 cell injection on peripheral blood immune cells and serum cytokines. Receives: Biological: CNK-UT009 cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
CNK-UT009 cell injection for the treatment of patients with type 1 diabetes Evaluation of the safety and tolerability of the user
Safety and tolerability endpoints: Adverse events that occurred after reinfusion of CNK-UT009 cell injection. The type, occurrence frequency and severity of (TEAE) determine that dose-limiting toxicity (DLT) is the greatest Tolerated dose (MTD)
Measured: The first cycle lasts for 21 days. The second to the fourth cycles each last for 14 days. The treatment follow-up period lasted for a total of 12 months
CNK-UT009 cell injection for the treatment of patients with type 1 diabetes Evaluation of the effectiveness of it
The primary efficacy endpoint: A 2-hour mixed meal tolerance test before and after reinfusion of CNK-UT009 cell injection The changes of the peak value of serum C-peptide and the area under the curve (AUC) after stimulation by (MMTT)
Measured: The first cycle lasts for 21 days. The second to the fourth cycles each last for 14 days. The treatment follow-up period lasted for a total of 12 months
Secondary outcomes (9)
To evaluate the pharmacokinetic (PK) characteristics of CNK-UT009 cell injection
peak concentration (Cmax)
Measured: The first cycle lasts for 21 days. The second to the fourth cycles each last for 14 days. The treatment follow-up period lasted for a total of 12 months
To evaluate the pharmacokinetic (PK) characteristics of CNK-UT009 cell injection
half-life (T1/2)
Measured: The first cycle lasts for 21 days. The second to the fourth cycles each last for 14 days. The treatment follow-up period lasted for a total of 12 months
To evaluate the pharmacokinetic (PK) characteristics of CNK-UT009 cell injection
Time to peak (Tmax)
Measured: The first cycle lasts for 21 days. The second to the fourth cycles each last for 14 days. The treatment follow-up period lasted for a total of 12 months
To evaluate the pharmacokinetic (PK) characteristics of CNK-UT009 cell injection
systemic clearance rate (CL)
Measured: The first cycle lasts for 21 days. The second to the fourth cycles each last for 14 days. The treatment follow-up period lasted for a total of 12 months
To evaluate the pharmacokinetic (PK) characteristics of CNK-UT009 cell injection
Volume of distribution (Vd)
Measured: The first cycle lasts for 21 days. The second to the fourth cycles each last for 14 days. The treatment follow-up period lasted for a total of 12 months
To evaluate the pharmacokinetic (PK) characteristics of CNK-UT009 cell injection
Area under the blood drug concentration-time curve (AUC）
Measured: The first cycle lasts for 21 days. The second to the fourth cycles each last for 14 days. The treatment follow-up period lasted for a total of 12 months
CNK-UT009 cell injection for the treatment of patients with type 1 diabetes Evaluation of peripheral blood immune cell subsets of the patient
The changes in the percentages of immune cell subsets in peripheral blood before and after the reinfusion of CNK-UT009, including but not limited to NKG2D-L(MICA/B, ULBP1/2/3/5/6) +T cells, B cells, Treg cells
Measured: The first cycle lasts for 21 days. The second to the fourth cycles each last for 14 days. The treatment follow-up period lasted for a total of 12 months
CNK-UT009 cell injection for the treatment of patients with type 1 diabetes Evaluation of serum cytokines of the patient
The changes of serum cytokines before and after reinfusion of CNK-UT009, including IL2, IL6, IL10, IFN-γ, and TNF-α Wait.
Measured: The first cycle lasts for 21 days. The second to the fourth cycles each last for 14 days. The treatment follow-up period lasted for a total of 12 months
CNK-UT009 cell injection for the treatment of patients with type 1 diabetes Evaluation of the immunogenicity of the individual
The binding ratio of antibodies (IgG) between CNK-UT009 cell injection and the serum of the subjects is directly reflected. The changes of antibody-mediated rejection (AMR) of the test subjects to the CNK-UT009 cell injection.
Measured: The first cycle lasts for 21 days. The second to the fourth cycles each last for 14 days. The treatment follow-up period lasted for a total of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start6 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zibo Central Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Xiaoming Pang, Doctor, Principal investigator, Zibo Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051564
- Sponsor's protocol ID
- 2024.NO.070-1
- Other IDs
- GCP-250106-004
- Acronym
- CNK-UT009
- Status last verified
- Jul 2025
- First submitted
- 7 Mar 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will disclose the safety and tolerability data of CNK-UT009 cell injection in the treatment of patients with type 1 diabetes, and elaborate on the maximum tolerated dose (MTD), the initial therapeutic effect, PK characteristics and immunogenicity of CNK-UT009 cell injection, as well as its impact on peripheral blood immune cells and serum cytokines.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Safety, Initial Efficacy and Pharmacokinetics of a Generic CNK-UT009 Cell Injection for the Treatment of Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07051564
- Acronym / sponsor ID
- CNK-UT009 / 2024.NO.070-1
- Conditions
- Type 1 Diabetes (T1D)
- Keywords
- Type 1 diabetes, CNK-UT009
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Zibo Central HospitalOther government
- Study start
- 6 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Jul 2025 (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 is a single-arm, open, investigator-initiated clinical study of CNK-UT009 cell injection in patients with type 1 diabetes. The purpose of this study is to evaluate the safety and tolerability of CNK-UT009 cell injection in patients with type 1 diabetes mellitus, determine the maximum tolerated dose (MTD), and evaluate the initial therapeutic effectiveness, PK characteristics and immunogenicity of CNK-UT009 cell injection. And the effect of CNK-UT009 cell injection on peripheral blood immune cells and serum cytokines.
Detailed description
The primary objective of this study is to evaluate the safety and tolerability of CNK-UT009 cell injection in the treatment of patients with type 1 diabetes and to determine the maximum tolerated dose (MTD).
Secondary objectives include:
- Assessing the preliminary efficacy of CNK-UT009 cell injection in treating patients with type 1 diabetes;
- Evaluating the pharmacokinetic (PK) characteristics of CNK-UT009 cell injection;
- Assessing the impact of CNK-UT009 cell injection reinfusion on peripheral blood immune cells;
- Assessing the impact of CNK-UT009 cell injection reinfusion on serum cytokines;
- Evaluating the immunogenicity of CNK-UT009 cell injection.
The primary endpoints of this clinical trial are:
- Safety and tolerability endpoints: Adverse events occurring after the reinfusion of CNK-UT009 cell injection, including the type, frequency, and severity of treatment-emergent adverse events (TEAEs), to determine the maximum dose-limiting toxicity (DLT) and tolerated dose (MTD);
- Primary efficacy endpoint: Changes in serum C-peptide peak and area under the curve (AUC) after a 2-hour mixed meal tolerance test (MMTT) before and after the reinfusion of CNK-UT009 cell injection.
Secondary research endpoints are:
- Secondary efficacy endpoints: Changes in the percentage of glycated hemoglobin (HbA1c) before and after the reinfusion of CNK-UT009 cell injection;
- Before and after the reinfusion of CNK-UT009 cell injection, the patient wore a continuous glucose monitoring system (CGM), measuring average glucose levels, time in range (TIR), time above range (TAR), and changes in time below range (TBR);
- Changes in the average daily insulin dosage within 7 days before and after the reinfusion of CNK-UT009 cell injection;
- Changes in the titer of islet autoantibodies before and after the reinfusion of CNK-UT009 cell injection.
Pharmacokinetics (PK): Changes in the number of CAR-positive cells in peripheral blood before and after the reinfusion of CNK-UT009 cell injection, and the dynamic changes in DNA copy number of T cells.
Peripheral blood immune cells: Subtypes of immune cells in peripheral blood before and after the reinfusion of CNK-UT009 cell injection, including but not limited to NKG2D-L (MICA/B, ULBP1/2/3/5/6) + T cells, B cells, and changes in the percentage of Treg cells.
Serum cytokines: Changes in serum cytokines (including IL2) before and after the reinfusion of CNK-UT009 cell injection, including IL6, IL10, IFN-γ, TNF-α, etc.
Immunogenicity: The binding ratio of CNK-UT009 cell injection to serum antibodies (IgG) in the subjects and the rate of change.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| This is a single-arm, open, investigator-initiated clinical study of CNK-UT009 cell injection in pat | Experimental | Biological: CNK-UT009 cell injectionThis is a single-arm, open, investigator-initiated clinical study of CNK-UT009 cell injection in patients with type 1 diabetes. The purpose of this study is to evaluate the safety and tolerability of CNK-UT009 cell injection in patients with type 1 diabetes mellitus, determine the maximum tolerated dose (MTD), and evaluate the initial therapeutic effectiveness, PK characteristics and immunogenicity of CNK-UT009 cell injection. And the effect of CNK-UT009 cell injection on peripheral blood immune cells and serum cytokines. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 to 65 years old (including the cut-off value), gender not limited;
- Diagnosed with autoimmune type 1 diabetes (meeting the diagnostic criteria of the "Chinese Guidelines for the Diagnosis and Treatment of Type 1 Diabetes (2021 Edition)"), and the peak C-peptide was ≥0.2nmol/L after 2-hour mixed meal (MMTT) stimulation during the screening period;
- At least one insulin autoantibody is positive, such as glutamate decarboxylase autoantibody (GADA), protein tyrosine phosphatase autoantibody (IA-2A), insulin autoantibody (IAA) (without insulin use or within 2 weeks of insulin treatment), zinc transporter antibody (ZnT8A);
- Glycated hemoglobin (HbA1c) ≥6.5% and ≤10.5%;
- Body mass Index (BMI)≥18kg/m ² and ≤35kg/m ²;
Key exclusion criteria (29 listed)
- Active malignant tumors requiring treatment, except for non-melanoma skin cancer or carcinoma in situ (such as breast, cervical);
- Subjects who have received organ transplants in the past or are preparing to receive organ transplants;
- Those who have received immunosuppressant treatment within 4 weeks before enrollment and/or require long-term immunosuppressive treatment during the study period, and are allowed to use topical, inhaled or intranasal corticosteroids intermittently;
- Any life-threatening bleeding events occurred within 3 months before enrollment, including the need for blood transfusion treatment, surgery or local treatment, and continuous drug treatment;
- A history of arterial or venous thromboembolic events within 6 months before enrollment, including myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or any other serious thromboembolic events. Thrombosis derived from implantable venous infusion ports or catheters, or superficial venous thrombosis, is excluded if the thrombus is stable after conventional anticoagulant therapy. Prophylactic use of small doses of low-molecular-weight heparin (such as enoxaparin 40 mg/ day) is permitted;
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 |
|---|---|---|
| CNK-UT009 cell injectionCNK-UT009 cell injection | Biological | This is a single-arm, open, investigator-initiated clinical study of CNK-UT009 cell injection in pat |
Primary outcome
CNK-UT009 cell injection for the treatment of patients with type 1 diabetes Evaluation of the safety and tolerability of the user
Time frame: The first cycle lasts for 21 days. The second to the fourth cycles each last for 14 days. The treatment follow-up period lasted for a total of 12 months
Safety and tolerability endpoints: Adverse events that occurred after reinfusion of CNK-UT009 cell injection. The type, occurrence frequency and severity of (TEAE) determine that dose-limiting toxicity (DLT) is the greatest Tolerated dose (MTD)
CNK-UT009 cell injection for the treatment of patients with type 1 diabetes Evaluation of the effectiveness of it
Time frame: The first cycle lasts for 21 days. The second to the fourth cycles each last for 14 days. The treatment follow-up period lasted for a total of 12 months
The primary efficacy endpoint: A 2-hour mixed meal tolerance test before and after reinfusion of CNK-UT009 cell injection The changes of the peak value of serum C-peptide and the area under the curve (AUC) after stimulation by (MMTT)
9 secondary outcomes
To evaluate the pharmacokinetic (PK) characteristics of CNK-UT009 cell injection
Time frame: The first cycle lasts for 21 days. The second to the fourth cycles each last for 14 days. The treatment follow-up period lasted for a total of 12 months
To evaluate the pharmacokinetic (PK) characteristics of CNK-UT009 cell injection
Time frame: The first cycle lasts for 21 days. The second to the fourth cycles each last for 14 days. The treatment follow-up period lasted for a total of 12 months
To evaluate the pharmacokinetic (PK) characteristics of CNK-UT009 cell injection
Time frame: The first cycle lasts for 21 days. The second to the fourth cycles each last for 14 days. The treatment follow-up period lasted for a total of 12 months
To evaluate the pharmacokinetic (PK) characteristics of CNK-UT009 cell injection
Time frame: The first cycle lasts for 21 days. The second to the fourth cycles each last for 14 days. The treatment follow-up period lasted for a total of 12 months
To evaluate the pharmacokinetic (PK) characteristics of CNK-UT009 cell injection
Time frame: The first cycle lasts for 21 days. The second to the fourth cycles each last for 14 days. The treatment follow-up period lasted for a total of 12 months
To evaluate the pharmacokinetic (PK) characteristics of CNK-UT009 cell injection
Time frame: The first cycle lasts for 21 days. The second to the fourth cycles each last for 14 days. The treatment follow-up period lasted for a total of 12 months
CNK-UT009 cell injection for the treatment of patients with type 1 diabetes Evaluation of peripheral blood immune cell subsets of the patient
Time frame: The first cycle lasts for 21 days. The second to the fourth cycles each last for 14 days. The treatment follow-up period lasted for a total of 12 months
CNK-UT009 cell injection for the treatment of patients with type 1 diabetes Evaluation of serum cytokines of the patient
Time frame: The first cycle lasts for 21 days. The second to the fourth cycles each last for 14 days. The treatment follow-up period lasted for a total of 12 months
CNK-UT009 cell injection for the treatment of patients with type 1 diabetes Evaluation of the immunogenicity of the individual
Time frame: The first cycle lasts for 21 days. The second to the fourth cycles each last for 14 days. The treatment follow-up period lasted for a total of 12 months
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 4 Jul 2025.
- Individual participant dataSharing planned: Yes. We will disclose the safety and tolerability data of CNK-UT009 cell injection in the treatment of patients with type 1 diabetes, and elaborate on the maximum tolerated dose (MTD), the initial therapeutic effect, PK characteristics and immunogenicity of CNK-UT009 cell injection, as well as its impact on peripheral blood immune cells and serum cytokines.
Related trials for Type 1 Diabetes (T1D)
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Active, not recruitingPhase 4
Diabetes in African Youth
type1diabetes
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.
Xiaoming Pang, Doctor principal investigator
Zibo Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CNK-UT009 cell injection in people with Type 1 Diabetes (T1D), run by Zibo Central Hospital 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 11 inclusion and 29 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: looking for participants now, as of the sponsor's last update on 4 Jul 2025. 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.
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?
Contact Xiaoming Pang, Doctor (+86-5332361126, pxm@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CNK-UT009 cell injection for the treatment of patients with type 1 diabetes Evaluation of the safety and tolerability of the user (time frame: The first cycle lasts for 21 days. The second to the fourth cycles each last for 14 days. The treatment follow-up period lasted for a total of 12 months). The study lists 2 primary outcomes in all. 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 4 Jul 2025.