Phase 1 Study of GNTI-122 Cell Therapy in Adults Recently Diagnosed with Type 1 Diabetes

What this Trial Is About

Researchers are evaluating the safety, tolerability, cellular behavior, and changes in C-peptide levels of GNTI-122, an investigational cell therapy made from a participants own blood cells. This Phase 1, single-arm, multi-center study involves adults recently diagnosed with Type 1 Diabetes T1D within 180 days of screening. The study aims to understand how this therapy affects disease markers and immune responses in these participants. Participants are enrolled sequentially into one of three groups Cohort 1 receives a low dose of GNTI-122, Cohort 2 receives a high dose, and Cohort 3 receives a high dose combined with rapamycin to potentially extend the therapys survival. Each participant receives a single dose of GNTI-122 and remains at the clinical site for at least 4 hours of observation after administration. Safety measures include sentinel dosing with waiting periods between participant treatments and review by a Safety Committee. Throughout the 78-week follow-up, participants undergo regular monitoring including vital signs, ECGs, physical exams, lab tests, and tracking of adverse events and medications. Disease markers like C-peptide and HbA1c, as well as immune activity indicators, are measured repeatedly. Rapamycin levels are also checked periodically in Cohort 3. After completing or leaving the study, participants will be monitored for up to 15 years for potential long-term effects as required by regulatory guidelines.

A Study of GNTI-122 in Adults Recently Diagnosed With T1D