A Study of GNTI-122 in Adults Recently Diagnosed With T1D
Part of paid clinical trials in Duarte, California.
- Sponsor
- GentiBio, Inc
- Study ID
- NCT06919354
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Type 1 Diabetes (T1D)
- Type 1 Diabetes Mellitus
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 55 Years
- Healthy Volunteers
- Not accepted
Interventions
- GNTI-122 — BIOLOGICALGNTI-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 Details
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!
Key Dates
- Start date
- Sep 3, 2025
- Status verified
- Apr 2026
- Primary completion
- Feb 29, 2028
- Completion
- Feb 29, 2028
Study Design
- Enrollment
- 16 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: GNTI-122
Primary Outcome Measure
Safety and tolerability of GNTI-122 with and without rapamycin in adult participants with recently diagnosed T1D [ Time Frame: Week 78 ]
Central Contacts
- Kristin M Neff857-327-5483
Locations (10)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | |
| University of California - San Diego | San Diego | California | 92093-0990 | Miguel Alvendia Jeremy Pettus, MD (PRINCIPAL_INVESTIGATOR) |
| University of California - San Francisco | San Francisco | California | 94158 | Stephen Gitelman, MD (PRINCIPAL_INVESTIGATOR) |
| University of Florida - Gainesville | Gainesville | Florida | 32610 | Brittany Bruggeman, MD (PRINCIPAL_INVESTIGATOR) |
| University of Miami, Diabetes Research Institute | Miami | Florida | 33136 | |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | Jason Gaglia, MD, MMSc (PRINCIPAL_INVESTIGATOR) |
| Columbia University | New York | New York | 10032 | Jacqueline Lonier, MD (PRINCIPAL_INVESTIGATOR) |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | Carol Levy, MD (PRINCIPAL_INVESTIGATOR) |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | John Buse, MD (PRINCIPAL_INVESTIGATOR) |
| Duke University | Durham | North Carolina | 27710 | Jennifer Green, MD (PRINCIPAL_INVESTIGATOR) |
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