Actively Recruiting
A Study of GNTI-122 in Adults Recently Diagnosed With T1D
Led by GentiBio, Inc · Updated on 2026-05-04
16
Participants Needed
10
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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!
CONDITIONS
Official 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.
- Participant has residual beta-cell function during Screening, defined as random C-peptide of at least 0.2 nmol/L.
- Positive for at least one Type 1 Diabetes-associated autoantibody.
- Able and willing to provide written, informed consent as approved by the IRB.
- Confirmed positive for the HLA-DRB1*04:01 allele.
- Has adequate vascular access to undergo leukapheresis with no known contraindications.
- Female participants of childbearing potential must have a negative serum pregnancy test at Screening, must not be lactating, and must agree to protocol-specified contraception.
- Male participants of childbearing potential must agree to protocol-specified contraception.
- Other than Type 1 Diabetes, participant is in good general health.
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.
- Has another 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
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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
CONTACT
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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