NCT07051564

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Zibo Central Hospital · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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: 1. Assessing the preliminary efficacy of CNK-UT009 cell injection in treating patients with type 1 diabetes; 2. Evaluating the pharmacokinetic (PK) characteristics of CNK-UT009 cell injection; 3. Assessing the impact of CNK-UT009 cell injection reinfusion on peripheral blood immune cells; 4. Assessing the impact of CNK-UT009 cell injection reinfusion on serum cytokines; 5. Evaluating the immunogenicity of CNK-UT009 cell injection. The primary endpoints of this clinical trial are: 1. 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); 2. 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: 1. Secondary efficacy endpoints: Changes in the percentage of glycated hemoglobin (HbA1c) before and after the reinfusion of CNK-UT009 cell injection; 2. 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); 3. Changes in the average daily insulin dosage within 7 days before and after the reinfusion of CNK-UT009 cell injection; 4. 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)

Interventions

Type	Name	Description
BIOLOGICAL	CNK-UT009 cell injection	CNK-UT009 cell injection

Timeline

• Start date: 2025-05-06
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-07-04
• Last updated: 2025-07-04

Locations

1 site across 1 country: China