CNK-UT009 investigational cell therapy
What it is
A small investigator-led cell-infusion study in adults with autoimmune T1D and residual insulin secretion. ClinicalTrials.gov lists recruiting, but its update is from July 2025 and no outcomes are posted.
Editorial review: . What was checked and what remains uncertain.
Latest dated source in the citation list: 2025-07-04. This is the source’s date, not a new review of every claim.
Trial status, labels and access can change between reviews.
Evidence behind this assessment
Key evidence notes. Study results, product eligibility and access answer different questions.
- Who was studied?
- Study populations and analysis groups vary. Product age limits alone do not describe who was studied.See the linked studies and their populations →
- Benefit or performance
- Beta-cell preservation: No clinical preservation result is posted for this programme.[1]
- Important harms and treatment burden
- Safety: The study is designed to assess safety; no programme-specific adverse-event results are posted.[1]
- Approval and country access
- A small investigator-led cell-infusion study in adults with autoimmune T1D and residual insulin secretion. ClinicalTrials.gov lists recruiting, but its update is from July 2025 and no outcomes are posted.Approval, trial recruitment, local supply and funding are separate. Check the cited label or access source.
- Follow-up and remaining uncertainty
- Durability: Lasting immune control or insulin independence has not been demonstrated in the registry.[1]
Research status alone does not establish approval, clinical benefit or local availability.
Editorial score: calculation and evidence
A weighted editorial judgment on a 0–100 scale, not a probability of success or a measured treatment effect. Higher criterion scores mean more favorable assessments.
Default calculation: 10 × 30 + 8 × 20 + 20 × 20 + 25 × 10 + 15 × 20 = 1410; divide by total weight 100. Unrounded weighted result: 14.1.
Lasting immune control or insulin independence has not been demonstrated in the registry.[1]
The study is designed to assess safety; no programme-specific adverse-event results are posted.[1]
Ages 18–65, autoimmune T1D with at least one autoantibody, stimulated C-peptide ≥0.2 nmol/L, and adequate organ function.[1]
Evidence is limited to an early registered study; planned enrolment is not a treated or analyzed cohort.[1]
The full picture
Scope of this entry
Zibo Central Hospital's open-label study plans 12 adults and tests CNK-UT009 safety, tolerability and dose limits. The public protocol also tracks C-peptide, insulin use and immune-cell measures. It lists phase as not applicable; this entry does not assign a clinical phase that the registry does not provide.1
The record was last updated in July 2025 and lists recruiting, with completion estimated for December 2026. The number planned is not a treated cohort, and the registry does not confirm present-day site availability.
No clinical outcomes are posted. The verified record does not fully characterize the cell manufacturing, target or pretreatment regimen. Those missing details prevent a reliable programme-specific safety synthesis. Changes in immune-cell measurements, if eventually reported, would not alone prove a cure or lasting insulin independence.
Sources
- [1]NCT07051564 — study record · registry · 2025-07-04 — Registry update date; retrieved 16 September 2026. Registry registration is not proof of clinical benefit.