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Investigating Tegoprubart and Islet Cell Transplant for Type 1 Diabetes and Kidney Disease

This study is looking into a new treatment for adults with Type 1 Diabetes (T1D) and chronic kidney disease (stages 2-3a). It combines two experimental components: Tegoprubart, a man-made protein that acts like an antibody (a natural immune system protein that fights illness), and human pancreatic islet cells. Islet cells are special cells in the pancreas that produce insulin. The goal is to see if these transplanted islet cells can start making insulin again, with Tegoprubart helping to prevent rejection. The study will assess the safety and effectiveness of this combination, specifically looking at how well participants' blood sugar is controlled one year after the transplant. You may be eligible if you are 18-70 years old, have had T1D for at least 5 years, and can use continuous glucose monitoring (CGM). This research will last about 5 years.

Study design
This is a single-arm study, meaning all participants will receive the same treatment. It plans to enroll 10 participants.
What's involved
Participation in this research will last about 5 years. You will need to comply with study procedures, including using continuous glucose monitoring (CGM).
Compensation
Not stated in the trial record.
Follow-up
The main outcomes will be measured at 1 year post-transplant, but overall participation in the research will last about 5 years.

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NCT07592000

Breakthrough - T1DM and Chronic Kidney Disease

Recruiting
PHASE1Ages 18–70InterventionalTreatment
University of Chicago
~10 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:TegoprubartIslet Cell Transplant

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants who are achieved Optimal outcomes according to Igls criteria
Measured over 1 year post-transplant
+1 more outcome measured

Conditions

Diabete Type 1
Chronic Kidney Disease

Explore related trials

Chronic Kidney DiseaseType 1 Diabetes MellitusC Peptide

Where it's being run

2 sites across 2 states
Florida1
Illinois1

Who to contact

Alexandra Grange - Islet Cell Transplant Program Manager
[email protected]
773-702-9771
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

IAH (HypoA-Q Impaired Awareness Subscale ≥12) and at least one level 3 SHE during the last year or
IAH and time-below-range (\<70 mg/dl) ≥4% with level 2 hypoglycemia (\<54 mg/dl) ≥1% (in Diabetes Care, Jan 2025, Patrick Choudhary) or
Clarke Score \>4 or
Recurrent SHE defined by two or more level 3 SHEs in the year prior to screening 10. If female, must be surgically sterile or postmenopausal. Women of childbearing potential may be enrolled if a pregnancy test is negative at screening/baseline. Women of childbearing potential and men with partners that are of childbearing potential must agree to use 2 forms of highly effective methods of contraception from Screening, throughout the study, and while receiving immunosuppressive therapy for the functioning graft after the conclusion of the study. Contraception use must continue for 90 days after the last administration of the study drug (see Appendix 5). Male participants must refrain from donating sperm for the duration of the study and agree to not donate sperm for 90 days after last administration of the study drug.

What this trial measures

  • Number of participants who are achieved Optimal outcomes according to Igls criteria1 year post-transplant

    Assessed by continuous glucose monitoring (CGM) for insulin independence, HbA1c\<7.0 (53 mmol/mol), and no severe hypoglycemic episodes (SHE).

  • Number of participants who are achieved Good outcomes according to Igls criteria1 year post-transplant

    Assessed by CGM for some insulin support, improved blood glucose control from baseline (pre-transplant), and with SHE.