Phase III Study of Allogeneic Thymus-Derived Treg Cells to Treat Immune Overreaction in COVID-19 and Acute Respiratory Distress Syndrome

What this Trial Is About

Researchers are evaluating allogeneic thymus-derived regulatory T cells thyTreg in a Phase III clinical trial to control immune overactivation linked to COVID-19 and Acute Respiratory Distress Syndrome ARDS. The study builds on prior findings showing thyTreg cells can help balance immune responses and may reduce harmful inflammation in severe respiratory conditions. This trial aims to assess the safety and efficacy of thyTreg cells in improving outcomes for adults with immune hyperactivation caused by these illnesses. The trial involves administering escalating doses of thyTreg cells intravenously as a single dose, with two dose levels studied 5 million and 10 million thyTreg cells per kilogram of body weight. Participants receive either the thyTreg treatment plus standard care or standard care alone, which includes treatments like dexamethasone. The study follows participants for up to 24 months to monitor treatment effects and safety. Participants will have regular assessments including clinical evaluations, blood tests to measure immune cells and inflammation markers, oxygenation status, heart function via echocardiography, and overall health status scores. Researchers will closely monitor infusion-related side effects and other safety indicators. The main outcome is the incidence of adverse events related to the cell therapy over two years, alongside secondary outcomes such as time spent in intensive care and changes in organ function and inflammation. This comprehensive monitoring helps understand the potential of thyTreg therapy in managing immune dysregulation in serious respiratory conditions.

Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Control the Immune Hyperactivation Associated With COVID-19 and/or Acute Respiratory Distress Syndrome (THYTECH2)