CNK-UT009 universal CAR-T / NKT injection in T1D
Recruiting Chinese investigator-initiated first-in-human study of CNK-UT009, a universal CAR-T / NKT cell product, in adults with autoimmune Type 1 diabetes who still have mixed-meal C-peptide of at least 0.2 nmol/L. Safety and MTD are the point. No results.
Primary endpoints
- Safety and tolerability, including dose-limiting toxicity and maximum tolerated dose
- Change in mixed-meal stimulated C-peptide peak and AUC
Results so far
No results. Recruiting. ClinicalTrials.gov NCT07051564 lists estimated n=12, actual start 6 May 2025, primary completion 31 December 2026. ChiCTR2600116392 (registered 9 January 2026, last WHO refresh 12 January 2026) describes the same product as a universal CNK-UT009 injection with target n=18 in dose groups plus 5 in expansion. Dual registration is not two programmes, and neither record has posted outcomes.
The full picture
CNK-UT009 is described as a universal (off-the-shelf) CAR-T / NKT cell injection aimed at resetting autoimmunity, not as replacement islets. The Zibo Central Hospital investigator study is small, open-label and dose-finding. Mixed-meal C-peptide of at least 0.2 nmol/L (about 0.6 ng/mL) is an entry filter, so this is not a trial in people with no residual insulin production.
ClinicalTrials.gov lists the phase as N/A; the protocol is a first-in-human MTD study, so this record is filed as Phase 1. Independent drug-profile sources name ST Phi Therapeutics as originator. An investigator-initiated cell-therapy protocol is not a ranked cure.