PIpepTolDC tolerogenic dendritic-cell vaccine
City of Hope / investigator-led
What it is
A personalized immune-tolerance vaccine made from a person's own dendritic cells loaded with proinsulin peptide, being tested by City of Hope in a small phase 1 T1D safety/manufacturing study. The goal is to teach immune tolerance to beta-cell antigens, but efficacy is completely unproven.
Editorial review: .
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
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: The registered phase 1 study is focused on safety and manufacturing; no beta-cell-preservation efficacy result has been posted.[1]
- Important harms and treatment burden
- Safety: Safety is exactly what the small phase 1 trial is assessing; until results post, risk is uncertain and manufacturing burden is high.[1]
- 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: Immune tolerance is the desired mechanism, but there are no durability data in T1D.[1]
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: 5 × 30 + 5 × 20 + 30 × 20 + 15 × 10 + 15 × 20 = 1300; divide by total weight 100. Unrounded weighted result: 13.
The registered phase 1 study is focused on safety and manufacturing; no beta-cell-preservation efficacy result has been posted.[1]
Safety is exactly what the small phase 1 trial is assessing; until results post, risk is uncertain and manufacturing burden is high.[1]
Personalized cell manufacturing plus the current adult-only phase 1 design make broad eligibility speculative.[1]
Earliest human stage: Phase 1 enrollment complete (actual n=6); primary completion 3 June 2024; still active-not-recruiting for follow-up (estimated completion 15 December 2026). No results posted.[1]
The full picture
PIpepTolDC belongs on the horizon list, not the near-term treatment list. It is scientifically elegant — a patient-specific dendritic-cell product designed to teach tolerance to proinsulin — but still at phase 1 safety and feasibility.
The registered study (NCT04590872) has finished enrollment (actual n=6). Primary completion was 3 June 2024; the record remains active, not recruiting, with estimated study completion 15 December 2026 and last update 22 April 2026. No results are posted. A passed primary-completion date is not an efficacy readout.
Coming soon
ETA · Phase 1 enrollment complete (n=6 actual); primary completion 3 June 2024; follow-up estimated through 15 December 2026. No results posted.
- →Phase 1 safety and manufacturing results
Sources
- [1]An Immunotherapy Vaccine PIpepTolDC for the Treatment of Patients With Type 1 Diabetes · Trial registry · 2026-04-22