NCT01911039

Phase 1 Infused Donor T Regulatory Cells in Steroid Dependent/Refractory Chronic GVHD

A Phase 1 Safety and Tolerability Study of Infused Donor T Regulatory Cells in Steroid Dependent/Refractory Chronic Graft Versus Host Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Laura Johnston · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Chronic graft versus host disease (cGVHD) is a common complication of bone marrow or hematopoietic cell transplant from another person (allogeneic transplant). This study will determine if subjects with steroid dependent/refractory cGVHD can tolerate infusion of donor regulatory T cells and whether their cGVHD responds to the infusion.

Detailed description

PRIMARY OBJECTIVES: Determine the safety and tolerability of donor T regulatory (Treg) cell infusions in subjects with steroid dependent/refractory chronic graft versus host disease. SECONDARY OBJECTIVES: 1. Determine the quantitative blood Treg cell changes following the cell infusions 2. Determine clinical efficacy of donor Treg cells as failure-free survival (FFS) defined by the absence of a new immunosuppressive therapy added, non-relapse mortality, and recurrent malignancy at Day 180 after the first Treg infusion 3. In addition to FFS, the study will measure the change in: 1. cGVHD symptom burden measured by the Lee cGVHD Symptom Scale by increase in \>7 points 2. NIH organ-specific cGVHD scale 3. The reduction in daily corticosteroid requirement of prednisone to \<=0.25 mg/kg-day at Day 180 after the first Treg infusion

Conditions

• Graft Versus Host Disease
• Allogeneic Hematopoietic Cell Transplant Recipient

Interventions

Type	Name	Description
BIOLOGICAL	Regulatory T Cells

Timeline

• Start date: 2013-07-01
• Primary completion: 2017-12-31
• Completion: 2018-07-31
• First posted: 2013-07-30
• Last updated: 2021-09-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study