GentiBio Announces First Participant Dosed in POLARIS Phase 1 Clinical Trial of GNTI-122 in Recently Diagnosed Type 1 Diabetes

Milestone marks first clinical evaluation of a targeted cell therapy designed to preserve natural insulin production

POLARIS trial enrolling at 10 specialized clinic sites across the U.S.

GentiBio on track to present key data in latter part of 2026 and 1H 2027 

Excerpt from the Press Release:

CAMBRIDGE, Mass., March 18, 2026 /PRNewswire/ — GentiBio, Inc., a clinical-stage biotechnology company pioneering engineered, antigen-specific regulatory T cell (EngTreg) therapies, today announced that the first participant has been dosed in POLARIS, a Phase 1 clinical trial evaluating GNTI-122, a novel single dose, autologous EngTreg investigational therapy for adults recently diagnosed with type 1 diabetes (T1D). GNTI-122 is designed to reduce or eliminate the need for life-long insulin injections in patients recently diagnosed with T1D.

“Dosing the first participant in the POLARIS trial is an important milestone for GentiBio and for the field of engineered immune tolerance,” said Mark Bach, Chief Medical Officer at GentiBio. “We are studying GNTI-122 in people recently diagnosed with type 1 diabetes, which gives us the opportunity, starting with the very first participant, to look for biological signals that targeted immune regulation may help preserve the body’s natural insulin production. We believe this approach can be transformative—and potentially curative—for people living with type 1 diabetes.”

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