NCT04128319

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Xenikos · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Steroid-Refractory Acute Graft Versus Host Disease

Interventions

Type	Name	Description
DRUG	T-Guard	Patients will receive 4 doses of T-Guard treatment, administered intravenously as four 4-hour infusions at least two calendar days (no less than 40 hours) apart. Each dose consists of 4 mg/m\^2 Body Surface Area (BSA).

Timeline

• Start date: 2019-11-21
• Primary completion: 2020-02-17
• Completion: 2020-02-17
• First posted: 2019-10-16
• Last updated: 2021-12-16
• Results posted: 2021-08-04

Locations

24 sites across 1 country: United States

Regulatory

• FDA-regulated drug study