Tregs plus anti-CD20 rituximab in pediatric stage 1 T1D
What this study tests
PolTREG phase 2 pediatric prevention trial testing expanded regulatory T cells, rituximab, their combination, or control in children with stage 1 type 1 diabetes. The registry version posted 17 July 2026 lists eligibility at ages 3-18 and disease-stage distribution at month 60 as a primary outcome.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2026-07-17.
Most recent recorded citation date: 2024-11-14. 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 at a glance
- Who can enter the study?
- Children aged 3-18 with presymptomatic stage 1 type 1 diabetes, body weight at least 20 kg and BMI from the 5th through 95th percentile, plus the registry's antibody, glucose and residual C-peptide criteria. 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 results posted. The study remains recruiting with 150 participants planned across nine Polish sites; the July 2026 revision added a Szczecin site. Time to first stage 2 dysglycemia is now a secondary rather than primary endpoint.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
- Proportion of participants in each arm who are in stage 1, stage 2 or stage 3 type 1 diabetes at month 60
- Adverse events at years 1 and 2 and at the end of the 60-month trial, compared with control arms
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]Treatment of Presymptomatic Stage 1 Type 1 Diabetes Pediatric Patients With Treg Cell Preparations and Anti-CD20 Antibody · Trial registry · 2024-11-14 — Revision posted 17 July 2026 broadened ages from 6-16 to 3-18, changed the BMI range, added the 20 kg minimum weight and Szczecin site, and revised the primary and secondary outcomes.