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Phase 2RecruitingNCT06688331

Tregs plus anti-CD20 rituximab in pediatric stage 1 T1D

PolTREG phase 2 pediatric prevention trial testing expanded regulatory T cells, rituximab, their combination, or control in children with stage 1 type 1 diabetes. A July 2026 registry revision broadened eligibility to ages 3-18 and made disease-stage distribution at five years a primary outcome.

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

Results so far

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.