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Phase 1RecruitingNCT06919354

POLARIS: GNTI-122 engineered Tregs in recent-onset T1D

What this study tests

GentiBio phase 1 study of GNTI-122, a one-time autologous engineered regulatory T-cell therapy made from the participant's own blood cells, in adults recently diagnosed with type 1 diabetes.

Editorial review: .

Registry checked: 2026-09-17. Registry’s own update: 2026-08-10.

Source dates appear in the references where available; this record has no dated citation metadata.

Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence

Full sources ↓Full discussion ↓Report an issue →

Evidence at a glance

Who can enter the study?
Adults aged 18-55 diagnosed within 180 days before screening, with random C-peptide at least 0.2 nmol/L, at least one T1D autoantibody, and confirmed HLA-DRB1*04:01. Adequate vascular access for leukapheresis is required; see registry for full criteria. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
Reported benefit and results
No results posted yet.Read the result sources and their limitations →
Important harms
Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
Research access and approval
Study regions: United States. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
What remains uncertain?
Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.

Research status alone does not establish approval, clinical benefit or local availability.

Primary endpoints

  • Safety and tolerability of GNTI-122 with and without rapamycin

The full picture

This record has no longer discussion. Use the study criteria, reported results and original sources on this page to assess what is known and what remains unresolved.

Sources

  1. [1]