T-Guard as Treatment for Steroid Refractory Acute GVHD (BMT CTN 1802) — 1802  

Steroid-Refractory Acute Graft Versus Host Disease Clinical Trial

Official title: An Open-Label, Single-Arm, Multicenter Study, of Combination Anti-CD3/CD7 Immunotoxin (T-Guard) for Steroid-Refractory Acute Graft-versus-Host Disease)

Status Terminated

Clinical Trial Summary

The study is designed as an open-label, single arm Phase III, multicenter trial to evaluate the efficacy and safety of T-Guard treatment in patients with Steroid-Refractory acute Graft versus Host Disease (SR-aGVHD).

Clinical Trial Description

Allogeneic Hematopoietic Cell Transplantation (allo-HSCT) is a potent immunotherapy with curative potential for several hematological disorders. Improvements in survival following allo-HSCT have led to its increasing use, but the leading cause of non-relapse mortality (NRM) remains graft-versus-host-disease (GVHD. Despite recent advances in the understanding of transplantation immune tolerance, aGVHD is a frequent and major complication of allo-HSCT involving activation of donor T-lymphocytes, which ultimately causes host tissue damage. T-Guard has a rapid onset, preferential killing of activated T cells, and short half-life, leading to depletion of allo-reactive T cells and quick post-treatment reconstitution of the immune system. ;

Related Conditions & MeSH terms

• Graft vs Host Disease
• Steroid-Refractory Acute Graft Versus Host Disease

• NCT number: NCT04128319
• Study type: Interventional
• Source: Xenikos
• Status: Terminated
• Phase: Phase 3
• Start date: November 21, 2019
• Completion date: February 17, 2020