NCT07592000RecruitingPhase 1/2

Breakthrough - T1DM and Chronic Kidney Disease

Multicenter, Phase 1/2 Pilot Study of Safety and Efficacy Assessment of Tegoprubart and Calcineurin Inhibitors- Free Immunosuppression Therapy for Pancreatic Islet Transplantation in Patients With T1DM and Chronic Kidney Disease

Source: ClinicalTrials.gov · Last updated 20 Aug 2026

Brief summary (registry, in English)

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).

Status (registry): Recruiting
Phase (registry): Phase 1/2
Study type: Interventional
Enrollment: 10 (estimated)
First submitted: 12 Jan 2026
Start date: Apr 2027
Primary completion date: Jan 2030
Lead sponsor: University of Chicago
Diseases: Chronic kidney disease
NCT number: NCT07592000

What you commit to

Study type: Interventional · Phase 1/2
Planned participants: 10
From Apr 2027 to the primary completion date, Jan 2030
2 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Receiving treatment for a medical condition requiring chronic use of systemic steroids, except for physiologic replacement for example in Addison disease.
Invasive aspergillus, histoplasmosis or coccidioidomycosis infection within one year prior to Screening.
Current treatment with any immunosuppressive regimen, and treatment with biologic immune modulating agents, JAK inhibitors, S1P receptor agonists, azathioprine, 6- MP, or systemic corticosteroids.
Previous organ transplant (except failed pancreas or islet transplant)
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.
Administration of live attenuated vaccine(s) within 2 months of Screening.
Any previous treatment with Tegoprubart or any other anti-CD40L therapy

Other illness

Chronic kidney disease stage 3b or above.
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.
History of substance abuse within the past 6 months.

Lab values

Diagnosis of macroalbuminuria (ACR\>300 mg/g creatinine).
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.
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.
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.

Other

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.
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.
Negative screen for Epstein-Barr Virus (EBV) by immunoglobulin G (IgG) determination.
Baseline PRA over 40%

Criteria the registry did not label

Participants are eligible for consideration for the study only if all of the following criteria apply at the time of screening Inclusion:
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).
Chronic kidney disease stage 1, 2 or 3a
Impaired awareness of hypoglycemia based on:
- 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
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.

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
The University Of Chicago Coordinator of this site? Confirm its status	Chicago	United States	Recruiting
Diabetes Research Institute, University of Miami Coordinator of this site? Confirm its status	Miami	United States	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.