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Phase 1Active, not recruitingNCT04590872

PIpepTolDC tolerogenic dendritic-cell vaccine

What this study tests

City of Hope phase 1 study of an autologous tolerogenic dendritic-cell vaccine loaded with proinsulin peptide in adults with type 1 diabetes, focused on manufacturing feasibility and safety.

Editorial review: .

Registry checked: 2026-09-17. Registry’s own update: 2026-04-22.

Most recent recorded citation date: 2026-04-22. 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?
Adults 18–45 with T1D for one to four years, historical islet autoantibodies, HbA1c at most 7.5%, stimulated C-peptide above 0.2 nmol/L and specified HLA-DRB1*04 alleles. The protective HLA-DRB1*15:01-DQA1*01:02-DQB1*06:02 haplotype and diabetes complications are exclusions; leukapheresis and two-year follow-up are required. 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 efficacy results posted. Enrollment is complete (actual n=6). Primary completion 3 June 2024; the live registry is ACTIVE_NOT_RECRUITING with estimated study completion 15 December 2026. Completion of enrollment is not a posted manufacturing or C-peptide result.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 States. 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 of adverse events through 2 years
  • Number of successful manufactured vaccine products

The full picture

This record has no longer discussion. Use the study criteria, reported results and original sources on this page to assess what is known and what remains unresolved.

Sources

  1. [1]