Study Name: A phase 1, single dose, open-label study of GNTI-122 in adults with recently diagnosed type 1 diabetes (T1D)
Principal Investigator: Brittany Bruggeman, M.D.
What is the GentiBio POLARIS study?
The purpose of this research is to test the investigational cell therapy GNTI-122 to see if it is safe for use in patients with Type 1 Diabetes (T1D), and to see if T1D improves after taking GNTI-122.
Who can participate?
- Participants who are between 18 and 45 years old
- Have recently been diagnosed with T1D (enrolled in study within 120 days of diagnosis)
What does participation in GentiBio POLARIS look like
Before you can take part in this study, you will need to participate in the GentiBio HLA study and have a positive result. If you are positive:
The GentiBio POLARIS study will include approximately 22 participants and will last about 20 months from the time of screening until the end of the study. If you decide to take part, participation will include the following stages:
Screening:
Blood work
Treatment:
If you are eligible, you will undergo leukapheresis (where white blood cells are collected from you in order to create GNTI-122). Once the study product is ready, you will receive it via IV. Depending on when you join the study, you may receive an additional study drug called rapamycin, which may help GNTI-122 work better. The study product will be given through the vein in your arm (intravenously, IV). During the study duration, the study team will monitor your health through check-ups and medical tests. There will be approximately 12 on-site visits to UF campus.
Want to learn more?
Call (352) 294-5760 or email our Study Coordinators: