Evaluating Treg Cell and Anti-CD20 Antibody Therapy to Prevent Type 1 Diabetes in Children Aged 3 to 18 with Early-Stage Disease

What this Trial Is About

Researchers are evaluating whether therapy using regulatory T cells Tregs lymphocytes andor an anti-CD20 antibody rituximab can safely treat or delay type 1 diabetes in children with pre-diabetes who are at high risk and still produce insulin normally. This phase 2, placebo-controlled, randomized, and blinded trial involves children aged 3 to 18 with early-stage type 1 diabetes stage 1 defined by specific autoantibodies and normal glucose levels. Participants are randomly assigned to one of four groups one receiving both Tregs and anti-CD20 antibody, one receiving Tregs with placebo, one receiving anti-CD20 antibody with sham Tregs, and one receiving placebo and sham Tregs. Treatments include two infusions of Tregs or sham at day 0 and around day 90, with four doses of anti-CD20 antibody or placebo given during this period. The intervention lasts about three months. After treatment, participants are followed for up to five years to monitor diabetes progression, safety, and side effects. Assessments include measuring the presence of autoantibodies, glucose tolerance, insulin production C-peptide, adverse events, and diabetes remission. The study aims to track how many participants remain in early-stage diabetes or progress, with regular medical evaluations throughout the extended follow-up period.

Treatment of Presymptomatic (Stage 1) Type 1 Diabetes Pediatric Patients With Treg Cell Preparations and Anti-CD20 Antibody