Phase 1 Type 1 Diabetes Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People aged 18 to 55 years who have been diagnosed with Type 1 diabetes within the last 180 days (about 6 months) before the screening visit.
- People whose pancreas is still producing some insulin, shown by a specific blood test result (called a C-peptide level) at or above a certain threshold during screening.
- People who test positive for at least one autoantibody linked to Type 1 diabetes.
- People who are willing and able to sign a written consent form approved by the relevant ethics board.
- People who carry a specific genetic marker called HLA-DRB1*04:01 (a gene variant identified through a blood test).
- People whose veins are suitable for a procedure that collects white blood cells from the blood (called leukapheresis), with no known reasons this procedure would be unsafe for them.
- Female participants of childbearing potential who test negative for pregnancy at screening, are not breastfeeding, and agree to use the contraception methods specified by the study.
- Male participants of childbearing potential who agree to use the contraception methods specified by the study.
- People who are otherwise in good general health, aside from their Type 1 diabetes diagnosis.
Who may not be able to join:
- People who have Type 2 diabetes.
- People who experienced a serious diabetes-related complication called diabetic ketoacidosis (DKA) within the 4 weeks before or during the screening period.
- People who are unwilling or unable to follow the study procedures and schedule.
- People who have a long-term or uncontrolled medical condition.
- People who have another active autoimmune or inflammatory disease — though well-controlled thyroid disease (Hashimoto's thyroiditis), coeliac disease, or vitiligo may be exceptions (confirm with trial site).
- People who are currently taking part in another clinical trial or are still in active follow-up from a previous study.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Mark Bach, MD, GentiBio, Inc
Phone: 857-327-5483
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Safety and tolerability of GNTI-122 with and without rapamycin in adult participants with recently diagnosed T1D
Can't join this trial?
Data last synced from ClinicalTrials.gov: 12 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.