Actively Recruiting
Multicenter Phase 1/2 Study of Tegoprubart and Calcineurin Inhibitor-Free Immunosuppression for Pancreatic Islet Transplant in Type 1 Diabetes and Chronic Kidney Disease
Led by University of Chicago · Updated on 2026-05-18
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Chicago
Lead Sponsor
B
Breakthrough T1D
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment approach for adults with brittle type 1 diabetes (T1D) and chronic kidney disease stages 1 to 3a. The study aims to assess the safety, tolerability, and effectiveness of a combination of an investigational drug called Tegoprubart and transplanted human pancreatic islet cells. These islet cells, which produce insulin, come from deceased donors and are considered investigational as they are not FDA-approved for this use. The study lasts about 5 years and is funded by Breakthrough T1D with oversight by the University of Chicago and Emerald Clinical Trials. Participants will receive a transplant of human pancreatic islet cells delivered through a catheter into the liver's portal vein. Along with the transplant, participants will receive immunosuppressive therapy including Tegoprubart, anti-thymocyte globulin (ATG), etanercept, and everolimus or mycophenolic acid (MPA). Tegoprubart is a monoclonal antibody designed to reduce immune system attack on the transplanted cells without harming them. The study tests if this combination can protect the islet transplant, reduce insulin dependence, and improve blood glucose control. During the study, participants will undergo regular assessments including continuous glucose monitoring (CGM) and blood tests to measure HbA1c, kidney function, and immune response. Researchers will monitor insulin independence, episodes of severe hypoglycemia, kidney disease progression, and other safety outcomes. Data will be collected at intervals up to 5 years post transplant to evaluate long-term effects and transplant success. Participants must comply with study procedures and contraception requirements throughout the study and up to 90 days after treatment ends.
CONDITIONS
Brief Title
Breakthrough - T1DM and Chronic Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- Diagnosis of type 1 diabetes for 5 or more years with disease onset before 40 years of age
- Ability to provide informed consent
- Ability to comply with study procedures including continuous glucose monitoring
- Using insulin pump or multiple daily injection therapy but unable to achieve good metabolic control due to unexplained severe hypoglycemia events
- HbA1c level between 6.5% and 9.5%
- Absence of stimulated C-peptide (<0.3 ng/mL) after mixed-meal tolerance test
- Chronic kidney disease stage 1, 2, or 3a
- Impaired awareness of hypoglycemia as defined by specific criteria including history of severe hypoglycemia events
- For females, must be surgically sterile or postmenopausal; women of childbearing potential must have a negative pregnancy test and agree to use two forms of contraception during and after the study; male participants must agree to use contraception and not donate sperm during and after the study
You will not qualify if you...
- Body mass index over 30 kg/m2
- Weight less than or equal to 40 kg
- Insulin requirement greater than 60 units/day or less than 15 units/day
- Untreated or uncontrolled proliferative diabetic retinopathy
- Blood pressure above 140/90 mmHg
- Chronic kidney disease stage 3b or higher
- Diagnosis of macroalbuminuria (ACR >300 mg/g creatinine)
- Positive pregnancy test, breastfeeding, or unwillingness to use contraception during and after study for females; intent to procreate or unwillingness to use contraception for males
- History of malignancy except fully removed skin cancers
- History of thromboembolic events or known clotting disorders requiring long-term anticoagulation
- Use of chronic systemic steroids (except physiologic replacement)
- Active infections including tuberculosis, HIV, hepatitis B or C
- Fungal infections within one year before screening
- Negative Epstein-Barr Virus IgG test
- Current treatment with immunosuppressive drugs or biologics
- Baseline panel reactive antibody over 40%
- Previous organ transplant (except failed pancreas or islet transplant)
- Elevated liver enzymes or bilirubin beyond specified limits
- Past experimental cell or gene therapy or recent investigational drug use
- History of substance abuse in past 6 months
- Severe cardiovascular disease
- Significant high cholesterol or triglycerides despite treatment
- Low blood counts unless cleared by hematologist
- Live attenuated vaccine within 2 months before screening
- Previous treatment with Tegoprubart or similar anti-CD40L therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure and immediate recovery period
Participants undergo a procedure where islet cells from a deceased donor are transplanted into the liver via a catheter to help restore insulin production.
1 transplant procedure visit
Duration - Up to 5 years
Participants receive Tegoprubart combined with immunosuppressive medications to prevent rejection of the transplanted islet cells and support insulin production.
Regular visits for medication administration and monitoring throughout the study
Duration - Up to 5 years following transplantation
Participants are monitored long-term for insulin independence, blood sugar control, kidney function, and safety outcomes after treatment.
Annual visits for assessments including blood sugar control and kidney function
Trial Site Locations
Total: 1 location
1
The University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
Research Team
A
Alexandra Grange - Islet Cell Transplant Program Manager
M
Minelly Escobedo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
0
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