Clinical Study on the Treatment of Type 1 Diabetes With CNK-UT009 Cell Injection
NCT07051564 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2025-07-04
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)
Interventions
- BIOLOGICAL
-
CNK-UT009 cell injection
CNK-UT009 cell injection
Sponsors & Collaborators
-
Zibo Central Hospital
lead OTHER_GOV
Principal Investigators
-
Xiaoming Pang, Doctor · Zibo Central Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-06
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
Countries
- China
Study Locations
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