NCT03683498

Donor Regulatory T-cells for Steroid-Refractory Chronic Graft-versus-host-Disease

A Phase I Trial of Donor Regulatory T-cells for Steroid-Refractory Chronic Graft-versus-Host-Disease in Patients Who do Not Obtain Complete Remission With Ruxolitinib

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

A Phase I Trial of Donor Regulatory T-cells for Steroid-Refractory Chronic Graft-versus-Host-Disease in patients who do not obtain complete remission with ruxolitinib

Detailed description

The study design is based on a phase I trial in Spanish. A number of 16 patients will be included to assess the safety and maximum tolerated dose-level of donor regulatory enriched T cell (Treg) in steroid-refractory chronic graft versus host disease (cGVHD) patients who did not obtain complete remission under treatment with ruxolitinib.

Conditions

• Chronic Graft vs Host Disease

Interventions

Type	Name	Description
BIOLOGICAL	Regulatory T-cell enriched infusion	Enrichment of CD25hi regulatory T cells from CD8 and/or CD19 pre-depleted leukapheresis products.

Timeline

• Start date: 2018-09-25
• Primary completion: 2022-03-24
• Completion: 2022-03-24
• First posted: 2018-09-25
• Last updated: 2022-05-23

Locations

1 site across 1 country: Spain