NCT05095649

Donor Regulatory T-cells for cGVHD in Patients Who do Not Obtain Complete Remission With Ruxolitinib

Phase II 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: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Phase II clinical trial to assess the efficacy of donor regulatory enriched T cells in steroid-refractory chronic graft versus host disease patients who did not obtain complete remission under treatment with ruxolitinib

Detailed description

A number of 15 patients will be included to assess the efficacy of donor regulatory enriched T cells in steroid-refractory chronic graft versus host disease patients who did not obtain complete remission after 12 weeks of treatment with ruxolitinib. The doses of Treg-enriched cells will be 2x10\^6 cells/kg. Survival at 1 year after Treg infusion will be represented based on the clinical data with Kaplan Meier curves.

Conditions

• Chronic Graft vs Host Disease

Interventions

Type	Name	Description
BIOLOGICAL	Regulatory T-cell enriched infusion	Enrichment of cluster of differentiation 25hi regulatory T cells from cluster of differentiation antigen 8 and/or cluster of differentiation antigen19 pre-depleted leukapheresis products.

Timeline

• Start date: 2022-03-24
• Primary completion: 2025-08-15
• Completion: 2026-02-15
• First posted: 2021-10-27
• Last updated: 2024-03-26

Locations

1 site across 1 country: Spain