Graft vs Host Disease Clinical Trial
Official title:
A Phase 1/2 Trial of Donor Regulatory T-cells for Steroid-Refractory Chronic Graft-versus-Host-Disease
Phase 1/2 clinical study for the treatment of steroid-refractory chronic graft versus host disease after an allogeneic transplant of hematopoietic progenitors with donor CliniMACS-selected regulatory T cells
Phase 1/2 clinical study evaluating safety (Phase 1) and preliminary efficacy (Phase 2) of
donor regulatory T cells for patients with steroid-refractory chronic graft versus host
disease (GVHD) after allogeneic hematopoietic stem cell transplantation (HSCT).
Patients must have persistent signs and symptoms despite the use of prednisone or equivalent
at ≥ 0.25 mg/kg/day (or 0.5 mg/kg every other day), for at least 4 weeks without complete
resolution of signs and symptoms. Occasional patients requiring lower doses of prednisone
will be eligible if associated with other immunosuppressive drugs.
Phase 1 clinical trial will include groups of 5 patients sequentially treated with: 0.5 x
10ˆ6, 1.0 x 10ˆ6, 2-3 x 10ˆ6 donor Treg/kg. Phase 2 clinical trial will include another 5 to
10 patients treated with MTD.
Donor Treg will be selected by the following sequential steps:
1. - negative depletion of CD8 and CD19 cells
2. - positive selection of CD25 cells
;
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