A Study of GNTI-122 in Adults Recently Diagnosed With T1D

ClinicalTrials.gov ID: NCT06919354

Open the official record

This page only displays public information reproduced from the official ClinicalTrials.gov record NCT06919354. It adds no medical advice, opinions, or eligibility judgments. The official record remains the source of truth for eligibility criteria, enrollment, and contact information.

View official ClinicalTrials.gov record → Back to search

ClinicalTrials.gov public records Last synced Nov 15, 2026, 9:41 AM EST

All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.

Official title

POLARIS: A Phase 1, Single Dose, Open-label Study of GNTI-122 in Adults With Recently Diagnosed Type 1 Diabetes (T1D)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a 78-week single arm, multi-center, Phase 1 study to evaluate the safety, tolerability, cellular kinetics, and biomarker changes in C-peptide over time of GNTI-122, an investigational cell therapy manufactured from a participant's own blood cells in adult participants with recently diagnosed T1D. After assessment of eligibility, participants who qualify for the study will be enrolled sequentially in 1 of 3 cohorts. Cohort 1 participants (n=3) receive a low dose of GNTI-122 . Cohort 2 participants (n=3) receive a high dose of GNTI-122. Cohort 3 participants (n=10) receive a high dose of GNTI-122 in combination with rapamycin. Participants are followed for 78 weeks after the administration of GNTI-122 during which safety and efficacy assessments are made, including vital signs, ECG, physical exam, clinical labs, and monitoring of adverse events and concomitant medications. Disease markers (e.g., MMTT-stimulated C-peptide, HbA1c) and pharmacodynamic activity (e.g., lymphocyte subsets and phenotypes, effector T cell responses to islet antigens ex vivo, T1D autoantibodies) will be monitored serially throughout the study. The study will include sentinel dosing and a Safety Review Committee to ensure participant safety. Visit https://www.polarisstudy.com to learn more!

Study identification

NCT ID: NCT06919354
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1
Lead sponsor: GentiBio, Inc; Industry
Enrollment: 16 participants

Conditions and interventions

Conditions

Interventions

GNTI-122 Biological

Biological

Eligibility (public fields only)

Age range: 18 Years to 55 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 3, 2025 (Actual)
Primary completion: Feb 2028 (Estimated)
Completion: Feb 2028 (Estimated)
Last update posted: Oct 20, 2026

2025 – 2028

United States locations

U.S. sites: 10
U.S. states: 5
U.S. cities: 9

Facility	City	State	ZIP	Site status
City of Hope Medical Center	Duarte	California	91010	Recruiting
University of California - San Diego	San Diego	California	92093-0990	Recruiting
University of California - San Francisco	San Francisco	California	94158	Recruiting
University of Florida - Gainesville	Gainesville	Florida	32610	Recruiting
University of Miami, Diabetes Research Institute	Miami	Florida	33136	Recruiting
Joslin Diabetes Center	Boston	Massachusetts	02215	Recruiting
Icahn School of Medicine at Mount Sinai	New York	New York	10029	Recruiting
Columbia University	New York	New York	10032	Not yet recruiting
University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	27514	Recruiting
Duke University	Durham	North Carolina	27710	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06919354, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 20, 2026 · Synced Nov 15, 2026