Clinical Study on the Treatment of Type 1 Diabetes With CNK-UT009 Cell Injection

NCT07051564 | Recruiting

• 2 other identifiers: 2024.NO.070-1GCP-250106-004
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Type 1 Diabetes (T1D)

Keywords

Type 1 diabetes; CNK-UT009

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  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

  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

  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

  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

  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

  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

Study Arms (1)

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.

Biological: CNK-UT009 cell injection

Interventions

CNK-UT009 cell injection BIOLOGICAL

CNK-UT009 cell injection

This is a single-arm, open, investigator-initiated clinical study of CNK-UT009 cell injection in pat

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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);

Sponsors & Collaborators

• Zibo Central Hospital: lead

Study Sites (1)

Zibo Central hospital

Zibo, Shandong, 255400, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Xiaoming Pang, Doctor

  Zibo Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoming Pang, Doctor

CONTACT

+86-5332361126; pxm@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: July 4, 2025
• Study Start: May 6, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: December 2025 -December 2027
• Access Criteria: We will make our IPD data public by publishing academic papers. Everyone can download the articles from the official websites of relevant journals to obtain our data。

Locations

CN (1)