ActiTrexx Initiates Treatment in Graft-versus-Host Disease Study with Novel T Cell Therapy

ActiTrexx GmbH has begun treating patients with a pioneering regulatory T cell therapy, Actileucel, aimed at countering Graft-versus-Host Disease (GvHD). The Phase Ib/II study targets the prevention and treatment of GvHD in recipients of allogeneic haematopoietic stem cell transplants for hematological malignancies, including acute leukemia. Actileucel is distinguished as the first therapy using regulatory T cells from an unmatched, third-party donor.

This novel cell therapy endeavors to mitigate the severe complication of GvHD, which affects approximately half of allogeneic haematopoietic stem cell transplant recipients. Current treatments, primarily immunosuppressants, offer limited efficacy and considerable side effects. Actileucel employs activated regulatory T cells to potentially control or avert GvHD, aiming to enhance patient outcomes significantly.

The clinical trial will examine the safety, feasibility, and effectiveness of Actileucel in ten leukemia patients post-transplant. It marks an innovative approach toward addressing the high mortality and morbidity associated with GvHD. The study's primary endpoint focuses on the therapy's safety and tolerability, with secondary objectives evaluating its impact on the incidence and severity of GvHD.

Conducted across two German sites, this study represents a hopeful stride towards developing a more effective treatment for preventing GvHD, with the potential to significantly improve patient quality of life and survival rates post-transplantation.