Actively Recruiting
POLARIS: A Phase 1, Single Dose, Open-label Study of GNTI-122 in Adults With Recently Diagnosed Type 1 Diabetes (T1D)
Led by GentiBio, Inc · Updated on 2026-05-04
16
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, cellular behavior, and biomarker changes of an investigational cell therapy called GNTI-122 in adults recently diagnosed with Type 1 Diabetes (T1D). This Phase 1, single-arm, multi-center study focuses on adults diagnosed within 180 days who have specific immune markers and residual beta-cell function. The study aims to understand how GNTI-122, made from a participant's own blood cells, affects disease markers and immune responses over time. Participants will be enrolled sequentially into one of three groups: Cohort 1 receives a low dose of GNTI-122; Cohort 2 receives a high dose; and Cohort 3 receives a high dose combined with rapamycin, which may help extend the therapy's survival. After receiving a single dose, participants stay for at least 4 hours for observation. Safety measures include sentinel dosing with waiting periods between participants and review by a Safety Review Committee. Over 78 weeks, participants will have regular assessments including vital signs, ECGs, physical exams, lab tests, and monitoring of side effects and medications. Disease activity will be tracked through C-peptide levels, HbA1c, immune cell profiles, and autoantibodies. Rapamycin levels will be checked in Cohort 3. After completing or leaving the study, participants will be followed for up to 15 years to monitor for long-term effects as per regulatory guidelines.
CONDITIONS
Brief Title
A Study of GNTI-122 in Adults Recently Diagnosed With T1D
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants aged 18 to 55 years with recently diagnosed (within 180 days of Screening) Type 1 Diabetes according to American Diabetes Association criteria
- Residual beta-cell function at Screening, defined as random C-peptide 0.2 nmol/L or higher
- Positive for at least one Type 1 Diabetes-associated autoantibody
- Able and willing to provide written, informed consent
- Confirmed positive for the HLA-DRB1*04:01 allele
- Adequate vascular access to undergo leukapheresis with no known contraindications
- Female participants of childbearing potential must have a negative pregnancy test at Screening, not be lactating, and agree to specified contraception
- Male participants of childbearing potential must agree to specified contraception
- In good general health aside from Type 1 Diabetes
You will not qualify if you...
- Type 2 diabetes
- Experienced diabetic ketoacidosis within 4 weeks prior to or during Screening
- Unwilling or unable to comply with study procedures or schedule
- Chronic or uncontrolled medical condition
- Active autoimmune or inflammatory disease except well-controlled Hashimoto's thyroiditis, celiac disease, or vitiligo
- Participation in another clinical study or active follow-up in a prior study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day with 4-hour observation
Participants receive a single dose of GNTI-122 cell therapy, with or without rapamycin, and remain at the clinical site for at least 4 hours for observation after administration.
1 treatment visit with observation
Duration - 78 weeks
Participants undergo safety and tolerability assessments, disease marker monitoring, and pharmacodynamic activity evaluations over the course of 78 weeks after treatment.
Multiple visits over 78 weeks for assessments
Trial Site Locations
Total: 10 locations
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
University of California - San Diego
San Diego, California, United States, 92093-0990
Actively Recruiting
3
University of California - San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
4
University of Florida - Gainesville
Gainesville, Florida, United States, 32610
Actively Recruiting
5
University of Miami, Diabetes Research Institute
Miami, Florida, United States, 33136
Actively Recruiting
6
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
7
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
8
Columbia University
New York, New York, United States, 10032
Not Yet Recruiting
9
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
10
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
K
Kristin M Neff
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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