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Phase 1Not yet recruitingNCT07493122

IMC-S118AI first-in-human dose-escalation in T1D

What this study tests

Immunocore Phase 1/1b single- and multiple-ascending-dose study of IMC-S118AI, a pre-proinsulin × PD-1 ImmTAAI molecule, in HLA-A*02:01-positive people with Type 1 diabetes who still make some of their own insulin. Safety is primary; mixed-meal C-peptide at week 25 is secondary. No results.

Editorial review: .

Registry checked: 2026-09-17. Registry’s own update: 2026-03-25.

Most recent recorded citation date: 2026-08-25. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.

Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence

Full sources ↓Full discussion ↓Report an issue →

Evidence at a glance

Who can enter the study?
HLA-A*02:01-positive people with T1D and residual beta-cell function; BMI 18–25 kg/m². ClinicalTrials.gov lists ages 18–45; CTIS lists 12–45. Prior T1D immunomodulators, cardiovascular disease and malignancy are excluded. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
Reported benefit and results
No results. ClinicalTrials.gov NCT07493122 remains not-yet-recruiting as of 25 March 2026 (estimated n=154, start April 2026, primary completion November 2030). EU CT 2025-524449-28-00 was authorised in July 2026 with an EU start of 10 August 2026 and estimated recruitment start 1 August 2026 (planned n=134; UK and Australia). Authorisation is not enrolment, and neither registry has posted efficacy tables.Read the result sources and their limitations →
Important harms
Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
Research access and approval
Study regions: United Kingdom, Australia. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
What remains uncertain?
Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.

Research status alone does not establish approval, clinical benefit or local availability.

Primary endpoints

  • Incidence and severity of adverse events, treatment-emergent events and serious events
  • Clinically significant changes in safety labs, vital signs and ECG
  • Dose interruptions, reductions or discontinuations

The full picture

This is Immunocore’s first Type 1 test of IMC-S118AI. Immunocore describes the molecule as designed to bind a pre-proinsulin peptide on HLA-A*02:01 beta cells and locally agonise PD-1. The trial asks whether single and repeated intravenous doses are tolerable, how the drug behaves in blood, and — only as a secondary question in the multiple-dose part — whether mixed-meal C-peptide at week 25 looks different from placebo.

Use both registries. ClinicalTrials.gov is the NCT record and is still not-yet-recruiting. CTIS is the more recent EU/UK/Australia authorisation. Do not treat an EU start date as a C-peptide result.

Sources

  1. [1]
    Study of IMC-S118AI in Type 1 Diabetes · Trial registry · 2026-03-25
  2. [2]