Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07051564

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

Led by Zibo Central Hospital · Updated on 2025-07-04

12

Participants Needed

1

Research Sites

86 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 65 years old (both inclusive), any gender
  • Diagnosed with autoimmune type 1 diabetes according to Chinese guidelines
  • Peak C-peptide  0.2 nmol/L after 2-hour mixed meal tolerance test (MMTT) during screening
  • Positive for at least one insulin autoantibody (e.g., GADA, IA-2A, IAA, ZnT8A)
  • Glycated hemoglobin (HbA1c) between 6.5% and 10.5%
  • Body mass index (BMI) between 18 kg/m2 and 35 kg/m2
  • Adequate organ and bone marrow function with specific blood counts, heart, lung, liver, and kidney function values within defined limits
  • Negative pregnancy test for women of childbearing age and agreement to use effective contraception during and up to 6 months after treatment
  • Agree to follow medical nutrition therapy guidelines for type 1 diabetes
  • Voluntarily agree to participate and comply with all study procedures
Not Eligible

You will not qualify if you...

  • Active malignant tumors requiring treatment except non-melanoma skin cancer or carcinoma in situ
  • History of organ transplant or planned organ transplant
  • Immunosuppressant treatment within 4 weeks before enrollment or need for long-term immunosuppressive therapy (topical/inhaled corticosteroids allowed intermittently)
  • Life-threatening bleeding events within 3 months before enrollment
  • History of arterial or venous thromboembolic events within 6 months before enrollment, except stable thrombosis after treatment
  • Severe bleeding tendency or coagulation dysfunction or currently on thrombolytic therapy
  • Uncontrolled hypertension above specified limits despite treatment
  • Symptomatic congestive heart failure (NYHA II-IV), significant arrhythmias, or congenital long QT syndrome
  • Pulmonary diseases including fibrosis, interstitial pneumonia, pneumoconiosis, or severe lung impairment
  • Active pulmonary tuberculosis or recent treatment within one year
  • Active hepatitis B or C, HIV, or known syphilis carriers
  • Severe active infection or poor clinical control within 4 weeks before enrollment
  • Diabetes complications such as ketoacidosis, renal insufficiency, active proliferative retinopathy, diabetic foot ulcer, amputation due to diabetes, or severe peripheral neuropathy
  • Use of non-insulin hypoglycemic drugs or glucose metabolism affecting drugs within 4 weeks or 5 half-lives before enrollment
  • Two or more severe unexplained hypoglycemic events within 6 months before enrollment
  • History of inability to complete MMTT or severe allergic reaction to MMTT components
  • Participation in other clinical studies within 4 weeks before enrollment
  • Use of attenuated live vaccines within 4 weeks before enrollment
  • Prior use of gene therapy products
  • Known allergy to any component of CNK-UT009 cell injection
  • Known mental illness or substance abuse interfering with study cooperation
  • Other life-threatening complications or conditions deemed inappropriate by the investigator

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Zibo Central hospital

Zibo, Shandong, China, 255400

Actively Recruiting

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Research Team

X

Xiaoming Pang, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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