GNTI-122 engineered Tregs (POLARIS)
GentiBio
A one-time autologous engineered regulatory T-cell therapy made from a person's own blood cells, designed to restore immune tolerance to pancreatic islets in recent-onset T1D. Phase 1 POLARIS is recruiting; no efficacy data yet.
The scorecard
The goal is beta-cell protection, and POLARIS measures biomarkers including C-peptide, but no human efficacy data are posted yet.[2]
Engineered Tregs are intended as a durable immune-tolerance reset, but persistence and durability in T1D remain unproven until follow-up reports.[1]
This is first-in-human autologous cell therapy in T1D; safety and tolerability are the primary endpoints, so risk is deliberately scored conservatively.[2]
Initial POLARIS enrollment is narrow: adults recently diagnosed with T1D, within roughly 120 days, at specialist US sites.[3]
The full picture
GNTI-122 is the most concrete engineered-Treg entry now in human testing for type 1 diabetes. The product is made from the participant's own blood cells and engineered to counter the autoimmune imbalance that destroys beta cells. POLARIS is a small phase 1, open-label study, so every score is still about plausibility and maturity rather than demonstrated disease modification. The reason it matters is strategic: if engineered Tregs can survive, traffic correctly, and preserve C-peptide without broad immune suppression, they could become the immune-protection half of a future cure stack.
Coming soon
ETA · Phase 1 POLARIS recruiting; primary completion estimated 2028
- →POLARIS phase 1 safety and biomarker follow-up · through 2028
Sources
- [1]GentiBio — GNTI-122 for new-onset type 1 diabetes · manufacturer
- [2]POLARIS phase 1 study of GNTI-122 in adults recently diagnosed with T1D (NCT06919354) · registry
- [3]GentiBio announces first participant dosed in POLARIS phase 1 clinical trial of GNTI-122 · manufacturer · 2026-04-14
- [4]Helmsley Trust and Breakthrough T1D support POLARIS trial of GNTI-122 · news · 2026-02-13