New York, New York, U.S., October 21, 2026
Breakthrough T1D has announced the expansion of a funded clinical trial evaluating pancreatic islet cell transplantation with Eledon Pharmaceuticals’ investigational immunosuppressive therapy, tegoprubart, to include people living with type 1 diabetes (T1D) and chronic kidney disease (CKD). The first participant in the expanded trial has received an islet cell transplant, marking an important development for patients who have historically been excluded from such studies because of concerns about kidney toxicity associated with conventional immunosuppressive medicines. The multicenter study is being conducted at the University of Chicago and the University of Miami, with funding of $8.5 million awarded by Breakthrough T1D to the University of Chicago. The research aims to investigate whether tegoprubart can help protect transplanted insulin-producing cells while reducing reliance on immunosuppressive treatments that may damage kidney function.
Tegoprubart Could Expand Access to Islet Cell Transplantation
Islet cell transplantation is an investigational treatment approach that involves transferring insulin-producing pancreatic islet cells from a deceased donor into a recipient. These cells can produce insulin and help regulate blood glucose levels, potentially reducing or eliminating the need for externally administered insulin in eligible patients. For people with type 1 diabetes, the immune system destroys insulin-producing beta cells, resulting in lifelong dependence on insulin therapy. Some patients also experience severe hypoglycemia or impaired awareness of dangerously low blood glucose, creating substantial challenges in managing the disease. However, transplant recipients require immunosuppressive medicines to prevent the immune system from rejecting the transplanted cells. Standard regimens commonly include tacrolimus, a calcineurin inhibitor associated with potential kidney toxicity and other adverse effects. These concerns have restricted access to islet transplantation for people with reduced kidney function. Tegoprubart is an investigational monoclonal antibody that blocks CD40 ligand (CD40L), a pathway involved in immune activation. By targeting this pathway, the therapy is designed to help prevent transplant rejection without relying on calcineurin inhibitors. Researchers hope this approach could preserve transplanted islet function while reducing the risk of treatment-related kidney damage.
Clinical Trial Includes Patients With Kidney Disease
The newly expanded clinical study is designed to enroll 10 adults with type 1 diabetes and early-stage chronic kidney disease. Eligible participants are between 18 and 70 years old, have lived with type 1 diabetes for more than five years, had disease onset before age 40, and experience impaired awareness of hypoglycemia. Participants must have Stage 1, Stage 2 or Stage 3a CKD. The study is evaluating deceased-donor islet transplantation alongside a tegoprubart-based, calcineurin inhibitor-free immunosuppression regimen. Investigators will assess whether the treatment can prevent rejection while supporting the function of transplanted insulin-producing cells. At one year after transplantation, the study plans to evaluate insulin independence, glycated hemoglobin (HbA1c) levels below 7% and the absence of severe hypoglycemic episodes, assessed using continuous glucose monitoring. These outcomes will help researchers determine whether the approach can provide meaningful improvements in glucose control and reduce dependence on external insulin. The expansion builds on an earlier investigator-initiated study at the University of Chicago Medicine. In that separate study, all 12 reported participants achieved insulin independence, with HbA1c levels below 6.5%. These encouraging results provide a rationale for continued research, but they do not establish that the expanded trial will produce the same outcomes in people with kidney disease.
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$8.5 Million Funding Supports Transplant Research
Breakthrough T1D’s $8.5 million investment supports the clinical investigation of islet transplantation in a population with substantial unmet medical needs. The organization is working to advance treatments that could improve everyday life for people with type 1 diabetes while supporting the development of potential disease-modifying and cell-based therapies. For Eledon Pharmaceuticals, the study expands the clinical investigation of tegoprubart beyond conventional transplant populations. The company is evaluating the therapy across multiple transplantation settings, including kidney transplantation and islet cell transplantation. The trial could provide important evidence about whether a targeted immunosuppression strategy can make islet transplantation more accessible to people whose kidney function limits their treatment options. Nevertheless, the study remains investigational, and additional clinical data will be needed to establish safety, efficacy and the durability of transplanted islet function. The expanded trial represents a significant research milestone for people living with type 1 diabetes and chronic kidney disease. Its results may help determine whether tegoprubart-based immunosuppression can broaden access to islet cell transplantation while addressing the kidney-related risks associated with conventional therapies.
Source: Breakthrough T1D, Eledon Pharmaceuticals press release
