Single arm- subject treated with Tegoprubart and everolimus.
The purpose of this research is to gather information on the safety and effectiveness of investigational regimen containing 2 experimental components:
* An investigational drug called Tegoprubart and
* Human pancreatic islet cells
Both Tegoprubart and human pancreatic islet cells are considered investigational because they are not approved for use in the United States by the Food and Drug Administration (FDA). Participation in this research will last about 5 years.
Assess safety, tolerability, and efficacy of transplanted islet cells and immunomodulation with Tegoprubart in combination with anti-thymocyte globulin (ATG), etanercept and with everolimus in adults with brittle T1D and chronic kidney disease (stage 2-3a).
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects 18-70 years of age.
. A diagnosis of T1D ≥5 years with onset of disease at \<40 years of age.
. Ability to provide informed consent.
. Able to comply with study procedures, including the requirement to utilize continuous glucose monitoring (CGM).
. Involvement in appropriate diabetes management in accordance with the standard of care, using an insulin pump or multiple daily injection (MDI) insulin therapy and, unable to achieve acceptable metabolic control because of the occurrence of unexplained SHEs.
. HbA1c level 6.5% to 9.5% inclusive.
. Absence of stimulated C-peptide (\<0.3 ng/mL) in response to a mixed- meal tolerance test (MMTT).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants who are achieved Optimal outcomes according to Igls criteria
Timeframe: 1 year post-transplant
2
Number of participants who are achieved Good outcomes according to Igls criteria
Timeframe: 1 year post-transplant
Trial details
NCT IDNCT07592000
SponsorUniversity of Chicago
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2030-01-31
Contact for this trial
Alexandra Grange - Islet Cell Transplant Program Manager
. Diagnosis of macroalbuminuria (ACR\>300 mg/g creatinine).
. For female participants: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 90 days after discontinuation. For male participants: intent to procreate during the duration of the study or within 90 days after discontinuation or unwillingness to use effective measures of contraception.