Tests GNTI-122, a cell therapy from patients' own blood, in recent type 1 diabetes
Tests GNTI-122, a cell therapy from own blood, in recently diagnosed adults.
Plain-language title generated from the registry record
Registry title: A Study of GNTI-122 in Adults Recently Diagnosed With T1D
Key facts
- Where
- Boston, Chapel Hill, Duarte, Durham, Gainesville, Miami, New York, San Diego, and San Francisco, United StatesSee the 10 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 55 years old?
Source: NCT06919354, who can take part
Where in United States
- Joslin Diabetes CenterBoston, United StatesTaking people
- University of North Carolina at Chapel HillChapel Hill, United StatesTaking people
- City of Hope Medical CenterDuarte, United StatesTaking people
- Duke UniversityDurham, United StatesTaking people
- University of Florida - GainesvilleGainesville, United StatesTaking people
- University of Miami, Diabetes Research InstituteMiami, United StatesTaking people
- Columbia UniversityNew York, United StatesNot yet recruiting
- Icahn School of Medicine at Mount SinaiNew York, United StatesTaking people
- University of California San DiegoSan Diego, United StatesTaking people
- University of California San FranciscoSan Francisco, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- GentiBio, Inc
- Trial code
- NCT06919354
- Record updated
- 20 October 2026
- Original 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, 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 full original descriptionShow less
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!
Inclusion: 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; 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; Male participants of childbearing potential must agree to protocol specified contraception; Other than T1D, participant is in good general health.
Exclusion: Experienced DKA within 4 weeks prior to or during Screening; Participation in another clinical study or active follow-up in a prior study; Type 2 diabetes; 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; Unwilling or unable to comply with study procedures or schedule.