GNTI-148: an off-the-shelf engineered regulatory T cell therapy for new-onset type 1 diabetes
Official title: GNTI-148: an allogeneic islet-specific engineered Treg for treating T1D
Funded at Gentibio, INC. · NIH-11400166 · Data updated 2026-11-12
A new, ready-to-use cell therapy derived from donor cells aims to restore immune tolerance and protect insulin-producing cells in people newly diagnosed with type 1 diabetes.
Quick facts
| Grant type | Sbir 2 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Gentibio, INC. NIH-funded |
| Lab location | 1 site (Cambridge, United States) |
| Project start | August 24, 2026 |
| Project end | July 31, 2028 |
| Funding year | 2026 |
| Award (this year) | $1,066,332 |
| NIH project number | 1R44DK148168-01 |
| Project ID | NIH-11400166 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates are individuals recently diagnosed with type 1 diabetes who have residual beta-cell function and are eligible for regulatory T cell therapies.
✕Less likely to help
Patients with advanced diabetes or those unable to tolerate cell-based therapies may not benefit.
What this research studies
This project develops GNTI-148, an allogeneic EngTreg product designed to specifically target pancreatic islets and sustain regulatory T cell function in newly diagnosed type 1 diabetes patients. The approach uses a proprietary platform to stabilize FOXP3, enable islet-specific targeting, and control IL-2 signaling, with the goal of halting disease progression. Researchers will build on prior autologous therapies to create a durable, off-the-shelf option that could be more accessible and cost-effective. The study is at the Phase II SBIR stage and focuses on translating a promising regulatory T cell strategy into a patient-facing treatment option.
Why it matters
Potential benefit: If successful, this therapy could prolong insulin independence and reduce disease progression in newly diagnosed patients.
How similar studies have gone: Previous autologous Treg therapies showed promise but faced challenges with stability and persistence; this project aims to overcome those with an off-the-shelf approach.
Where this research is happening
-
Gentibio, INC.
Cambridge, United States Active
Researchers
- Principal investigator: Uenishi, Gene Ichiro — Gentibio, INC.
- Study coordinator: Uenishi, Gene Ichiro
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.