Type 1 Diabetes (T1D)Phase 1POLARISNCT06919354
A Study of GNTI-122 in Adults Recently Diagnosed With T1D
A Phase 1 study testing GNTI-122 in people with Type 1 Diabetes (T1D) and Type 1 Diabetes Mellitus, run by GentiBio, Inc at 10 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Type 1 Diabetes (T1D), Type 1 Diabetes Mellitus
- What is being tested?
- GNTI-122
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 10 sitesUnited States
- Study dates
- 3 Sep 2025to Feb 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female participants aged ≥18 to ≤55 years with recently diagnosed (within 180 days of Screening) T1D according to American Diabetes Association criteria.
- Participant has residual β-cell function during Screening, defined as random C-peptide ≥ 0.2 nmol/L.
- Positive for at least one T1D-associated autoantibody.
- Able and willing to provide written, informed consent as approved by the IRB.
- Is confirmed positive for the HLA-DRB1*04:01 allele.
- Has adequate vascular access to undergo leukapheresis with no known contraindications.
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- 8. Female participants of childbearing potential must have a negative serum pregnancy test at Screening, must be not lactating, and must agree to protocol-specified contraception.
- 9. Male participants of childbearing potential must agree to protocol specified contraception.
- 10. Other than T1D, participant is in good general health.
Who cannot join
- Type 2 diabetes.
- Experienced DKA 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 or autoimmune or inflammatory disease with the exception of well-controlled Hashimoto's thyroiditis, celiac disease, or vitiligo.
- Participation in another clinical study or active follow-up in a prior study.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Joslin Diabetes Center
Boston, Massachusetts, 02215
Michelle Zhang, Study Coordinator, 888-813-8669, T1DTrials@joslin.harvard.edu
Jason Gaglia, MD, MMSc
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Rachael Unger, 984-974-3004, uncdiabetes@med.unc.edu
John Buse, MD
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Fouad Kandeel, MD, PhD, 866-444-7538, islets@coh.org
Fouad Kandeel, MD, PhD
- Recruiting
Duke University
Durham, North Carolina, 27710
Megan Reaves, 919-660-2272, megan.reaves@duke.edu
Jennifer Green, MD
- Recruiting
University of Florida - Gainesville
Gainesville, Florida, 32610
Jennifer Hosford, 352-294-5759, jennifer.hosford@peds.ufl.edu
Brittany Bruggeman, MD
- Recruiting
University of Miami, Diabetes Research Institute
Miami, Florida, 33136
Carlos Blaschke, MD, 305-243-4485, cblaschke@miami.edu
Julia Oliveira, 305-243-3466, jmd636@med.miami.edu
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Camilla Levister, NP, 212-241-5177, Camilla.levister@mssm.edu
Carol Levy, MD, 212-241-0068, carol.levy@mssm.edu
- Not yet recruiting
Columbia University
New York, New York, 10032
Amy Doytchinov, 646-581-2532, berrietrials@cumc.columbia.edu
Jacqueline Lonier, MD
- Recruiting
University of California - San Diego
San Diego, California, 92093-0990
Mateo Santizo, 858-249-4020, alphastemcellclinic@health.ucsd.edu
Miguel Alvendia
- Recruiting
University of California - San Francisco
San Francisco, California, 94158
Rebecca Wesch (Recruitment Coordinator), 844-813-8273, clinicalresearch@diabetes.ucsf.edu
Stephen Gitelman, MD
About this study
Official title: POLARIS: A Phase 1, Single Dose, Open-label Study of GNTI-122 in Adults With Recently Diagnosed Type 1 Diabetes (T1D)
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!
Read the detailed description
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 in adult participants with recently (within 180 days of Screening) diagnosed T1D. GNTI-122 is an investigational cell therapy manufactured from a participant's own blood cells and is intended to help correct an imbalance of certain types of cells found in patients with Type 1 Diabetes (T1D).
After assessment of eligibility, participants who qualify for the study will be enrolled sequentially in 1 of 3 cohorts. Cohorts 1 and 2 are safety run-in cohorts (n=3 participants per cohort) in which each participant receives a single dose of GNTI 122 alone; Cohort 1 receives a low dose 1 of GNTI-122 and Cohort 2 receives a high dose of GNTI-122. Cohort 3 includes 10 participants that will receive a single high dose of GNTI-122 in combination with rapamycin (with a target trough concentration [Ctrough] of 3 to 6 ng/mL), which may extend the survival of GNTI-122. Participants will remain at the clinical site for observation for at least 4 hours after administration of GNTI-122.
Safety and tolerability assessments over the 78-week study include: vital signs, 12-lead electrocardiograms, physical examinations, clinical laboratory evaluations, monitoring of adverse events and concomitant medications. Risks to participants will be minimized by the incorporation of sentinel dosing (i.e., at least 28 days of safety assessments between first and second participant and at least 14 days between the second and third participant in Cohorts 1 and 2, and at least 14 days between the first and second participant and the second and third participant in Cohort 3) and the evaluation of safety and tolerability by a Safety Review Committee with at least 14 days of safety assessments (i.e., laboratory values and adverse event reporting) after 3 participants are dosed in Cohort 1 and Cohort 2. 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.
In Cohort 3, rapamycin concentrations will be measured periodically to ensure levels are in the target range of Ctrough level between 3 and 6 ng/mL.
Per Health Authority guidelines (Food and Drug Administration) for gene therapy products or advanced medicinal products, all participants treated with GNTI-122 who complete or discontinue from this study must be monitored for specific toxicities for a total of 15 years (semi-annually or annually), irrespective of their response to GNTI-122. This will be addressed in a separate protocol of a long-term follow-up study of these participants.
- Conditions
- Type 1 Diabetes (T1D), Type 1 Diabetes Mellitus
- Being tested
- GNTI-122
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GNTI-122Biological
GNTI-122 is an investigational cell therapy manufactured from a participant's own blood cells and is intended to help correct an imbalance of certain types of cells found in participants with Type 1 Diabetes.
| Study group | Role | What they receive |
|---|---|---|
| GNTI-122 | Experimental | Not described Receives: Biological: GNTI-122 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of GNTI-122 with and without rapamycin in adult participants with recently diagnosed T1D
Cumulative AEs/SAEs and clinically significant abnormalities in physical exams, vital signs, clinical laboratory measures, and other clinical assessments
Measured: Week 78
Secondary outcomes (3)
Cellular kinetics of GNTI-122 with and without rapamycin in adult participants with recently diagnosed T1D
Measurement of maximum concentration of circulating engineered regulatory T cells as measured by droplet digital polymerase chain reaction
Measured: Week 78
Cellular kinetics of GNTI-122 with and without rapamycin in adult participants with recently diagnosed T1D
Measurement of area under the concentration-time curve [AUC] of circulating engineered regulatory T cells
Measured: Week 78
Cellular kinetics of GNTI-122 with and without rapamycin in adult participants with recently diagnosed T1D
Measurement of half-life of circulating engineered regulatory T cells
Measured: Week 78
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start3 Sep 2025
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GentiBio, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- California Institute for Regenerative Medicine (CIRM)
- Responsible party
- Sponsor
- Investigators
- Mark Bach, MD, Study director, GentiBio, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919354
- Sponsor's protocol ID
- GNTI-122-T1D-1001
- Other IDs
- CLIN2-20416
- Acronym
- POLARIS
- Status last verified
- Oct 2026
- First submitted
- 25 Mar 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sponsor will share study results via a publication or conference presentation.