GNTI-122 for Type 1 Diabetes
(POLARIS Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, since participants must be on insulin therapy, you will likely continue with that medication.
What is the purpose of this trial?
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.
Research Team
Mark Bach, MD
Principal Investigator
GentiBio, Inc
Eligibility Criteria
Adults recently diagnosed with Type 1 Diabetes (T1D) are eligible for this trial. It's important that they meet certain health standards to be included, but specific inclusion criteria aren't listed here. Those who have other medical conditions or circumstances that could interfere with the study may not qualify.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of GNTI-122, with Cohort 3 also receiving rapamycin
Follow-up
Participants are monitored for safety and efficacy, including vital signs, ECG, and clinical labs
Long-term follow-up
Participants are monitored for specific toxicities for a total of 15 years
Treatment Details
Interventions
- GNTI-122
Find a Clinic Near You
Who Is Running the Clinical Trial?
GentiBio, Inc
Lead Sponsor