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

Graft Versus Host Disease Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Allogeneic Hematopoietic Cell Transplant Recipient
• Graft Versus Host Disease
• Graft vs Host Disease

• NCT number: NCT01911039
• Study type: Interventional
• Source: Stanford University
• Status: Completed
• Phase: Phase 1
• Start date: July 2013
• Completion date: July 31, 2018