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

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

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.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: GentiBio, Inc (Industry-sponsored)
• Locations: 10 sites (Duarte, California and 9 other locations)
• Trial ID: NCT06919354 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Duarte, California and 9 other locations

• 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)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
• Columbia University — New York, New York, United States (Not_yet_recruiting)
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
• Duke University — Durham, North Carolina, United States (Recruiting)

Study contacts

• Study coordinator: Kristin M Neff

Conditions Type 1 Diabetes; Type 1 Diabetes Mellitus