Leiden tolerogenic dendritic-cell therapy
LUMC / Cure One (investigator-led)
What it is
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.
Editorial review: .
Most recent recorded citation date: 2026-06-26. 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
Evidence behind this assessment
Key evidence notes. Study results, product eligibility and access answer different questions.
- Who was studied?
- Study populations and analysis groups vary. Product age limits alone do not describe who was studied.See the linked studies and their populations →
- Benefit or performance
- Beta-cell preservation: 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]
- Important harms and treatment burden
- Safety: Primary aim is safety in adults with T1D diagnosed within five years. LUMC reported no adverse effects in the first treated participant; that is n=1, not a safety table.[2]
- Approval and country access
- Country-specific approval and access are not summarized in this record.Approval, trial recruitment, local supply and funding are separate. Check the cited label or access source.
- Follow-up and remaining uncertainty
- Durability: Protocol follow-up is two years. Nothing has been shown to last after the injections stop.[2]
Research status alone does not establish approval, clinical benefit or local availability.
Editorial score: calculation and evidence
A weighted editorial judgment on a 0–100 scale, not a probability of success or a measured treatment effect. Higher criterion scores mean more favorable assessments.
Default calculation: 8 × 30 + 6 × 20 + 32 × 20 + 18 × 10 + 22 × 20 = 1620; divide by total weight 100. Unrounded weighted result: 16.2.
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 adults with T1D diagnosed within five years. 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) · Trial 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 · Science journalism · 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.