Early Phase 1 Study of Allogeneic CD7-Targeted CAR-T Cell Therapy for Adults with Type 1 Diabetes Mellitus

What this Trial Is About

Type 1 diabetes mellitus T1DM is an autoimmune disease where the bodys immune system attacks pancreatic beta cells, causing insulin deficiency and requiring lifelong insulin therapy. This condition involves loss of immune tolerance and is associated with autoantibodies and inflammation of the islets. Current insulin treatment does not address the underlying immune cause, so new immune-based therapies are needed to explore whether altering immune cells can protect beta-cell function. This early phase 1 study aims to evaluate the safety, early effectiveness, and behavior of an allogeneic CD7-targeted CAR-T cell injection in people with early stage T1DM. Participants will receive a single intravenous infusion of the investigational CAR-T cell therapy called RD13-02 using a dose-escalation plan starting at a low dose. If no significant toxicities occur within 28 days, the dose may increase. If toxicities are seen, the study will adjust accordingly or stop. Up to nine participants will be enrolled. The study will monitor safety closely and assess biological activity to determine the best dosing approach. Throughout the study, participants will undergo regular evaluations including tests of safety, immune cell behavior, blood sugar control, insulin use, beta-cell function through mixed-meal tolerance tests, and immune markers. These assessments will occur from baseline up to one year after infusion. The research team will track adverse events and measure changes in biomarkers to gather early evidence on how this CAR-T therapy may affect T1DM. Participants will be followed for up to 12 months to monitor treatment effects and safety.

Allogeneic Anti-CD7 CAR-T for Type 1 Diabetes