This study is testing an investigational cell therapy called GNTI-122 in adults who have been recently diagnosed with Type 1 Diabetes (T1D). GNTI-122 is made from your own blood cells and aims to correct an imbalance of certain cells in T1D. The study will look at how safe GNTI-122 is and how well your body tolerates it, both alone and when given with another medicine called rapamycin. To join, you must be between 18 and 55 years old, have T1D diagnosed within the last 180 days, show some remaining beta-cell function (measured by C-peptide levels), and have at least one T1D-related autoantibody. The main goal is to check safety and tolerability over 78 weeks.

Study design

This is a single-arm, multi-center study with 16 participants. It is a Phase 1 study, meaning it's an early stage of testing a new treatment.

What's involved

You would be observed at the clinical site for at least 4 hours after receiving GNTI-122. Safety and tolerability will be assessed over 78 weeks through vital signs, EKGs, physical exams, lab tests, and monitoring for side effects.

Compensation

Not stated in the trial record.

Follow-up

You will be followed for safety and tolerability for 78 weeks after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.