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Clinical trial Recruiting at 9 sites Phase 1 Interventional Ages 18 to 55

GNTI-122 cell therapy for adults recently diagnosed with type 1 diabetes

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

Run by GentiBio, Inc · NCT06919354 · Data updated 2026-11-12

This test uses an experimental cell therapy made from your own blood, called GNTI-122, to try to preserve insulin production in adults who were recently diagnosed with type 1 diabetes.

More Type 1 Diabetes Mellitus trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years to 55 Years
SexAll
Enrollment16 (estimated)
SponsorGentiBio, Inc
Industry-sponsored
Locations10 sites (Duarte, California and 9 other locations)
StatusRecruiting
StartedSeptember 3, 2025
Main results expectedFebruary 2028
Study endsFebruary 2028
Registry record updatedOctober 20, 2026
Trial IDNCT06919354 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–55 within 180 days of a type 1 diabetes diagnosis who have residual C-peptide (≥0.2 nmol/L), at least one diabetes autoantibody, are HLA-DRB1*04:01 positive, and can undergo leukapheresis are the intended candidates.

Probably not a fit

People with long-standing type 1 diabetes, absent measurable C-peptide, a diagnosis of type 2 diabetes, or who do not carry the required HLA-DRB1*04:01 allele are unlikely to benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a 78-week, single-arm Phase 1 study that enrolls adults recently diagnosed with type 1 diabetes to receive an autologous cell therapy (GNTI-122). Participants undergo leukapheresis to produce the investigational product and are enrolled sequentially into three cohorts: low dose (n=3), high dose (n=3), and high dose plus rapamycin (n=10). The study focuses on safety and tolerability while measuring cellular kinetics and biomarkers such as MMTT-stimulated C-peptide and HbA1c over time. Participants are closely monitored with vital signs, ECGs, labs, and adverse event tracking and remain in follow-up visits for 78 weeks after dosing.

Why it matters

Potential benefit: If successful, GNTI-122 could help preserve remaining beta-cell function and reduce insulin needs in people newly diagnosed with type 1 diabetes.

How similar studies have gone: Immune-based approaches have shown some success in preserving beta-cell function (for example teplizumab), but autologous cell therapies like GNTI-122 are an emerging and largely unproven approach in early-phase human studies.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Male and female participants aged ≥18 to ≤55 years with recently diagnosed (within 180 days of Screening) T1D according to American Diabetes Association criteria.
2. Participant has residual β-cell function during Screening, defined as random C-peptide ≥ 0.2 nmol/L.
3. Positive for at least one T1D-associated autoantibody.
4. Able and willing to provide written, informed consent as approved by the IRB.
5. Is confirmed positive for the HLA-DRB1\*04:01 allele.
6. Has adequate vascular access to undergo leukapheresis with no known contraindications.

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.

Exclusion Criteria:

1. Type 2 diabetes.
2. Experienced DKA within 4 weeks prior to or during Screening.
3. Unwilling or unable to comply with study procedures or schedule.
4. Chronic or uncontrolled medical condition.
5. Has another active or autoimmune or inflammatory disease with the exception of well-controlled Hashimoto's thyroiditis, celiac disease, or vitiligo.
6. Participation in another clinical study or active follow-up in a prior study.

Where it's running

  • City of Hope Medical Center
    Duarte, California, United States     Recruiting
  • University of California - San Diego
    San Diego, California, United States     Recruiting
  • University of California - San Francisco
    San Francisco, California, United States     Recruiting
  • University of Florida - Gainesville
    Gainesville, Florida, United States     Recruiting
  • University of Miami, Diabetes Research Institute
    Miami, Florida, United States     Recruiting
  • Joslin Diabetes Center
    Boston, Massachusetts, United States     Recruiting
Show 4 more locations
  • Icahn School of Medicine at Mount Sinai
    New York, New York, United States     Recruiting
  • University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina, United States     Recruiting
  • Duke University
    Durham, North Carolina, United States     Recruiting
  • Columbia University
    New York, New York, United States     Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Type 1 Diabetes (T1D) 56Type 1 Diabetes Mellitus 62Gentibio, INC. 6
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.