Breakthrough - T1DM and Chronic Kidney Disease

Recruiting now · Phase 1/Phase 2

Conditions studied: Diabete Type 1, Chronic Kidney Disease

In brief

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).

Key facts

Study ID

NCT07592000

Run by

University of Chicago

People needed

10

Starts

2027-04-29

Expected to finish

2030-01-31

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Body mass index (BMI) >30 kg/m2.
• Weight ≤40 kg.
• Insulin requirement >60units/day or <15 units/day.
• Untreated and uncontrolled proliferative diabetic retinopathy.
• Blood pressure: systolic blood pressure (SBP) >140 mmHg or diastolic blood pressure (DBP) >90 mmHg.
• Chronic kidney disease stage 3b or above.
• 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.
• History of malignancy except for completely resected squamous or basal cell carcinoma of the skin.
• History of a thromboembolic event (TE), known hypercoagulable state, or condition requiring long-term anticoagulation:
• Participants with a history of clotted venous access not requiring long- term anticoagulation may be included at the Principal Investigator's discretion if they have no other history of TEs or known hypercoagulable state.
• Patients on aspirin are allowed.
• Receiving treatment for a medical condition requiring chronic use of systemic steroids, except for physiologic replacement for example in Addison disease.
• Presence of ongoing active infection including tuberculosis (TB), human immunodeficiency virus (HIV), hepatitis B, hepatitis C. Laboratory evidence of active infection even in the absence of clinical symptoms of infection is exclusionary.
• Invasive aspergillus, histoplasmosis or coccidioidomycosis infection within one year prior to Screening.
• Negative screen for Epstein-Barr Virus (EBV) by immunoglobulin G (IgG) determination.
• Current treatment with any immunosuppressive regimen, and treatment with biologic immune modulating agents, JAK inhibitors, S1P receptor agonists, azathioprine, 6- MP, or systemic corticosteroids.
• Baseline PRA over 40%
• Previous organ transplant (except failed pancreas or islet transplant)
• Persistent elevation of serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value greater than 3 times the upper limit of normal (ULN); elevation of total bilirubin >1.5 ULN.
• Any history of receiving experimental cell or gene therapy. Exposure to any other experimental or investigational agent within 30 days or 5 half-lives; whichever is longer.
• History of substance abuse within the past 6 months.
• Severe cardiovascular disease characterized by any one of these conditions: a) stroke; b) recent myocardial infarction (within past 6 months); c) evidence of ischemia on functional cardiac exam within the last year; d) left ventricular ejection fraction<30%.
• Significant hyperlipidemia despite medical therapy defined as fasting low-density lipoprotein (LDL) cholesterol >130 mg/dL and/ or triglycerides >200 mg/dL.
• Baseline Hb below the lower limits of normal at the local laboratory; lymphopenia (<1,000/µL), neutropenia (<1,500/µL), or thrombocytopenia (platelets <100,000/µL). Participants with lymphopenia are allowed if the Principal Investigator determines there is no additional risk and obtains clearance from a hematologist.

Where it is running

• The University of Chicago — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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