drugset
drugset / Trial / NCT01911039

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

NCT01911039 ↗

Phase 1 Completed 14 enrolled Laura Johnston National Institutes of Health (NIH) · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2013-07
Primary completion
2017-12-31
Completion
2018-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Regulatory T cells Cell therapy 100000 cells/kg —
Subject Regulatory T cells Cell therapy 500000 cells/kg —
Subject Regulatory T cells Cell therapy 1.5e+06 cells/kg —

Indications

graft versus host disease