Leiden tolerogenic dendritic-cell therapy
LUMC / Cure One (investigator-led)
An autologous tolerogenic dendritic-cell injection developed at LUMC, now in a recruiting Dutch Phase 1b for adults with T1D diagnosed within five years. The June 2026 “first patient treated” note is n=1 and not a posted result.
The scorecard
Target n=10; safety and immunological effect are the questions. No C-peptide table is posted. A first-patient news item is not preservation.[1]
Protocol follow-up is two years. Nothing has been shown to last after the injections stop.[2]
Primary aim is safety in people who still make some of their own insulin. LUMC reported no adverse effects in the first treated participant; that is n=1, not a safety table.[2]
Adults 18–64 with T1D for five years or less, Netherlands only, personalised cell manufacturing.[1]
EU CTIS 2023-508558-25-01 is ongoing, recruiting (NL start December 2024; last update 24 March 2026). Distinct from City of Hope PIpepTolDC. No Phase 2 efficacy trial.[1]
The full picture
Leiden's programme takes a person's own precursor cells, turns them into tolerogenic dendritic cells in the lab, and injects them into the skin, aiming to teach the immune system to leave beta cells alone. It is a different product from City of Hope's PIpepTolDC vaccine.
The registered study is a Phase 1b in the Netherlands (EUCT 2023-508558-25-01), recruiting, planned n=10. LUMC's 26 June 2026 note that a first patient has been treated without adverse effects is a press count, not posted C-peptide data. Safety first, then maybe a larger efficacy study — years away from being a treatment.
Coming soon
ETA · Phase 1b recruiting in Leiden; no efficacy timeline
Sources
- [1]EUCT 2023-508558-25-01 — Tolerogenic dendritic cell therapy in type 1 diabetes (Phase 1b) · registry · 2026-03-24 — Ongoing, recruiting in the Netherlands. Academisch Ziekenhuis Leiden. Ages 18–64. Trial start 2 December 2024.
- [2]First patient treated in new phase of promising type 1 diabetes research · news · 2026-06-26 — LUMC states ten participants, T1D diagnosed within five years, two-year follow-up, and that the first patient's treatment phase is complete with no adverse effects so far. n=1 is not a result.