Purpose of this Study
This study is for people with type 1 diabetes (T1D). Their immune system attacks cells in the body that make insulin. A new treatment called GNTI-122 is made from their own blood cells and may help stop this attack. People will be in one of three groups: low dose, high dose, or high dose with another medicine called rapamycin. The study includes several visits to check if the treatment works and is safe.
Who Can Participate?
Eligibility
his study is for adults who are between 18 and 45 years old. They must have been told they have Type 1 Diabetes in the last 120 days. They need to have a certain gene called HLA. They cannot have other diseases that affect the immune system. They also cannot be pregnant or breastfeeding during the study, which lasts about one and a half years. People who had cancer in the last five years cannot join, except for some types of skin cancer.
Age Range
18-45
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study will last about 78 weeks. It is testing a new treatment called GNTI-122. This treatment is made from a person's own blood cells. Doctors want to see if it is safe and if it can help people with Type 1 Diabetes. The treatment might protect the cells in the body that make insulin. Right now, GNTI-122 has not been approved by health experts like the FDA.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
DEA01: A PHASE 1, SINGLE DOSE, OPEN-LABEL STUDY OF GNTI-122 IN ADULTS WITH RECENTLY DIAGNOSED TYPE 1 DIABETES (T1D)
Principal Investigator
Jennifer
Green
Protocol Number
PRO00118254
NCT ID
NCT06919354
Phase
I
Enrollment Status
Open to Enrollment