16 September 2026 editorial review · Trial
Tegoprubart: calcineurin-inhibitor-free islet-transplant immunosuppression: review notes
These notes document the scope actually reviewed, including source-access limits. They are not independent clinical certification or a guarantee that every claim was verified.
Read the trial evidence page →Primary-agent trial review — 16 September 2026
Assessment: Summary, current status, primary endpoint and key eligibility compared with the current registry. No additional discrepancy confirmed in that comparison. Historical outcome details beyond the primary sources explicitly discussed in the specialist ledgers were not all independently reverified.
Registry: NCT06305286; ACTIVE_NOT_RECRUITING; updated 2026-08-11; enrollment 70 (ESTIMATED); results not posted.
Endpoint comparison: Number of Participants who are insulin-independent post- first and final transplant (Day 75 and Day 365).
Sources for this record: 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 (registry); Eledon announces updated data from investigator-initiated islet transplant trial of tegoprubart in patients with type 1 diabetes at UChicago Medicine (manufacturer); Eledon announces updated data from investigator-initiated islet transplant trial of tegoprubart in patients with type 1 diabetes at UChicago Medicine (manufacturer); ADA 2026 recap: days 3 and 4 (community); CD40-CD40L Blockade: Update on Novel Investigational Therapeutics for Transplantation (peer-reviewed).
Limits: Source access and review depth vary. Registry fields establish the registered study, not clinical benefit, product approval or current local access. Cited-source reachability alone was not treated as verification of its claims.
Selected cell-therapy and adjunct trial review — 16 September 2026
Outcome and correction: Retained 12/12 sponsor-reported insulin independence; distinguished initial cohort from registry target 70. Removed unproved comparative safety/superiority and speculative policy claims. Added omitted immunosuppression-related adverse events managed through mycophenolic-acid dose reduction. Updated stale citation status and detailed eligibility.
Primary sources checked: Registry NCT06305286; Eledon June 8, 2026 primary company report.
Limits: Single-arm interim company/conference report, median follow-up eight months. Absence of selected toxicity signals cannot establish safer therapy. Continuing immunosuppression explicit.
Validation: npm run validate passed after correcting the CIRM citation source to the supported community enum (primary funder report described in its note).