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Phase 1/2RecruitingNCT06305286

Tegoprubart: calcineurin-inhibitor-free islet-transplant immunosuppression

University of Chicago investigator-led Phase 1/2 trial testing donor-islet transplantation with tegoprubart (AT-1501), an anti-CD40L monoclonal antibody, as the core of a tacrolimus-free immunosuppression regimen. It does not remove immunosuppression, but it targets a major bottleneck in islet cures: the kidney/metabolic/neurotoxicity burden of calcineurin inhibitors. Company interim updates report insulin independence in early participants; peer- reviewed final efficacy data are not yet available.

Primary endpoints

  • Number of participants who are insulin-independent after first and final transplant at Day 75 and Day 365

Results so far

ClinicalTrials.gov lists the study as recruiting with 70 estimated participants and no posted results. Eledon reported on June 8, 2026 that all 12 participants in the initial cohort had achieved insulin independence, with participants producing endogenous insulin and no longer requiring exogenous insulin to manage T1D. Treat this as sponsor-reported interim data pending peer-reviewed publication and longer follow-up.

The full picture

What is being tested

This trial keeps the proven donor-islet-transplant idea but changes the immune-drug strategy. Tegoprubart (AT-1501) is an anti-CD40L monoclonal antibody used as part of a calcineurin-inhibitor-free, tacrolimus-free regimen after allogeneic islet transplantation.1 The goal is not to avoid immunosuppression entirely; it is to avoid a standard drug class whose kidney, neurologic, metabolic, and cardiovascular toxicities limit the transplant trade-off.1

Design

The registry lists a Phase 1/2, open-label, non-randomized, single-group study at the University of Chicago, with 70 estimated participants aged 18-65.1 The primary endpoint is insulin independence after first and final transplant at Day 75 and Day 365.1

Current signal

Eledon reported in March 2026 that the 12-patient cohort was fully enrolled and that 10 participants more than 4 weeks after transplant had achieved insulin independence, with no signs of graft rejection or de novo donor-specific HLA antibodies.2 On June 8, 2026, the company updated the cohort to 12 of 12 participants insulin-independent, producing endogenous insulin and no longer requiring exogenous insulin to manage T1D.3 That is clinically important if it holds, but it is still sponsor-reported interim data. Final peer-reviewed results and longer follow-up are still needed.

Why it matters

Tegoprubart does not solve donor-islet scarcity and does not create a drug-free cure. But if it improves graft survival while reducing calcineurin-inhibitor toxicity, it could make existing islet transplantation safer and more durable for the severe-hypoglycemia population while stem-cell and immune-protection approaches mature.

References

  1. University of Chicago. Safety, Tolerability, and Efficacy of Immunomodulation With a Monoclonal Antibody Against CD40L in Combination With Transplanted Islet Cells in Adults With Brittle Type 1 Diabetes Mellitus. ClinicalTrials.gov NCT06305286. https://clinicaltrials.gov/study/NCT06305286 ↩ ↩2 ↩3 ↩4

  2. Eledon Pharmaceuticals. Eledon Announces Updated Data from Investigator-Initiated Islet Transplant Trial of Tegoprubart in Patients with Type 1 Diabetes at UChicago Medicine. https://ir.eledon.com/news-releases/news-release-details/eledon-announces-updated-data-investigator-initiated-islet ↩

  3. Eledon Pharmaceuticals. Eledon Announces Updated Data from Investigator-Initiated Islet Transplant Trial of Tegoprubart in Patients with Type 1 Diabetes at UChicago Medicine (June 8, 2026 update). https://ir.eledon.com/news-releases/news-release-details/eledon-announces-updated-data-investigator-initiated-islet-0 ↩