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NCT06919354 · ClinicalTrials.gov registry record · Phase 1
A Study of GNTI-122 in Adults Recently Diagnosed With T1D
A Phase 1 study of Type 1 Diabetes Mellitus and Type 1 Diabetes (T1D), sponsored by GentiBio.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 10
- Study locations
NCT06919354: Recruiting Phase 1 study of Type 1 Diabetes Mellitus and Type 1 Diabetes (T1D), sponsored by GentiBio.
NCT06919354 is a Phase 1 study of Type 1 Diabetes Mellitus and Type 1 Diabetes (T1D) that is actively recruiting participants, run by GentiBio. The registered enrollment target is 16 participants, below the 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (91% lower). The trial reports 10 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06919354, a Phase 1 study of Type 1 Diabetes Mellitus and Type 1 Diabetes (T1D), is actively recruiting participants, sponsored by GentiBio.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 10
- Study locations
Study 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. 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!
Primary Outcome
Cumulative AEs/SAEs and clinically significant abnormalities in physical exams, vital signs, clinical laboratory measures, and other clinical assessments
Conditions Studied
Interventions
- BIOLOGICAL GNTI-122
Study Locations (10)
California
- City of Hope Medical Center - Duarte
- University of California - San Diego - San Diego
- University of California - San Francisco - San Francisco
Florida
- University of Florida - Gainesville - Gainesville
- University of Miami, Diabetes Research Institute - Miami
New York
- Icahn School of Medicine at Mount Sinai - New York
- Columbia University - New York
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
- Duke University - Durham
Massachusetts
- Joslin Diabetes Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2025-09-03 |
| Est. Completion | 2028-02 |
| Phase | Phase 1 |
What NCT06919354 shows while recruiting
NCT06919354 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 1 intervention - of which GNTI-122 is the first listed.
NCT06919354 lists 10 locations in 5 states (California, Florida, New York).
Frequently Asked Questions
What is clinical trial NCT06919354 about?
NCT06919354 is a clinical study titled "A Study of GNTI-122 in Adults Recently Diagnosed With 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...
What is the current status of trial NCT06919354?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2025-09-03. Estimated completion is 2028-02.
What conditions does trial NCT06919354 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus, Type 1 Diabetes (T1D).
What interventions are being tested in trial NCT06919354?
The interventions under investigation include: GNTI-122 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06919354?
This trial is sponsored by GentiBio, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06919354 being conducted?
This trial has 10 study locations across California, Florida, Massachusetts, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06919354's enrollment target sits among peer trials
16 97th of 112 higher than 12 of 112 other Type 1 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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