NCT02385019

A Phase 1/2 Trial of Donor Regulatory T-cells for Steroid-Refractory Chronic Graft-versus-Host-Disease

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Instituto de Medicina Molecular João Lobo Antunes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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

Conditions

• Graft vs Host Disease

Interventions

Type	Name	Description
BIOLOGICAL	Donor regulatory T cell adoptive immunotherapy in chronic graft versus host disease	Regulatory T cells selected by a sequential 2 step procedure: 1. \- Negative selection of CD8 and CD19 cells 2. \- Positive selection of CD25 cells

Timeline

• Start date: 2015-03-01
• Primary completion: 2019-03-01
• Completion: 2019-12-01
• First posted: 2015-03-11
• Last updated: 2018-03-06

Locations

3 sites across 1 country: Portugal