GentiBio has announced the dosing of the first participant in its Phase I clinical trial, POLARIS, evaluating GNTI-122, a novel engineered regulatory T cell (EngTreg) therapy for adults recently diagnosed with Type 1 Diabetes (T1D).

GNTI-122 is a single-dose, autologous investigational therapy designed to target autoimmune responses and potentially reduce or eliminate the need for lifelong insulin injections. The therapy aims to preserve the body’s natural insulin production by protecting pancreatic cells from immune system attacks.

The POLARIS study will assess the safety, tolerability and key efficacy biomarkers of GNTI-122 in adults within 120 days of T1D diagnosis. The trial is being conducted across 10 specialised clinical sites in the United States, with the first patient dosed at the University of North Carolina, Chapel Hill.

Commenting on the milestone, Mark Bach, Chief Medical Officer, GentiBio, said the trial offers an opportunity to explore whether targeted immune regulation can preserve insulin production from the earliest stages of the disease, potentially transforming treatment outcomes.

Investigators John Buse and Klara Klein from the University of North Carolina highlighted the significance of early intervention in T1D, noting that protecting insulin-producing pancreatic cells could dramatically improve patient quality of life.

GNTI-122 has been engineered to function effectively within the inflammatory environment characteristic of T1D, where natural regulatory T cells often fail. The therapy leverages GentiBio’s platform to generate stable and durable EngTregs that specifically target the pancreas, aiming to halt the autoimmune process.

GentiBio plans to present initial findings from the POLARIS trial in late 2026 and early 2027, marking a potential step forward in developing disease-modifying therapies for type 1 diabetes.