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Phase 1/2Recruiting2023-508558-25-01

LUMC Phase 1b: tolerogenic dendritic cells in recent-onset T1D

What this study tests

Recruiting Dutch Phase 1b of autologous tolerogenic dendritic-cell therapy in adults with T1D diagnosed within five years. Target n=10. Safety and immune effect are the questions. No results posted.

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

Full sources ↓Full discussion ↓Report an issue →

Evidence at a glance

Who can enter the study?
The registry uses the adult age band 18–64; LUMC describes participants diagnosed with T1D within five years who retain insulin production. Two Dutch sites are listed: LUMC in Leiden and Diabeter Rotterdam. The public API does not provide the full inclusion/exclusion text; confirm exact eligibility with the study team. 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
The official CTIS API lists a target of 10, trial start 2 December 2024 and recruitment start 18 June 2025, with no recruitment-end event. The latest modification decision is 24 March 2026; the record publication timestamp is 25 March 2026. Two sites are listed: LUMC and Diabeter Rotterdam. LUMC reported on 26 June 2026 that the first participant had completed treatment with no adverse effects so far, with two further years of follow-up planned. This is a first-participant safety update, not a posted C-peptide efficacy result; the CTIS results object is empty.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: European Union. 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

  • Short-term safety of autologous tolerogenic dendritic-cell injections
  • Immunological effect (protocol-defined)

The full picture

CTIS calls this a Phase 1b safety and immunological-effect study in its public title, while its structured phase category is integrated Phase I/II-other. The primary purpose described by LUMC is safety. A first-patient update cannot establish efficacy.32

Sources

  1. [1]
    EUCT 2023-508558-25-01: Tolerogenic dendritic cell therapy in type 1 diabetes · Trial registry · 2026-03-25 — Record publication timestamp 25 March 2026; latest modification decision 24 March. Phase category is integrated I/II-other; public title calls it phase 1b. Age18–64 is a registry band, not independently checked detailed eligibility.
  2. [2]
    First patient treated in new phase of promising type 1 diabetes research · Science journalism · 2026-06-26

    LUMC. First patient treated in new phase of promising type1 diabetes research,26June2026.

  3. [3]
    Official CTIS public API: EUCT2023-508558-25-01 · Trial registry

    Official CTIS public record and API: title, phase category, age band, sites and recruitment notifications.