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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Enrichment of CD25hi regulatory T cells from CD8 and/or CD19 pre-depleted leukapheresis products.
Hospital Universitario Virgen del Rocío
Seville, Seville, Spain
Toxicity and maximum tolerated dose
To determine the maximum tolerated dose (MTD) and toxicity of Treg-enriched infusion among patients receiving ruxolitinib.
Time frame: Up 12 weeks after infusion
Quantification of targeted cells of manufacturing Treg-enriched product meeting the targeted cell dose-level.
Percentage of cells viability, negative gram stain/endotoxin, percentage of CD4+CD25+ cells and CD4+CD25+CD127- Treg in order to consider for the infusion.
Time frame: Before 24 hours to infusion up infusion day
Clinical response of Treg-enriched infusion
Each participant should be assigned one of the following categories: 1) complete cGVHD response per NIH criteria, 2) partial cGVHD response per NIH criteria, 3) non-response (includes stable disease) per NIH criteria, 4) progressive cGVHD per NIH criteria, 5) malignant disease relapse, or 6) unknown (not assessable, insufficient data).
Time frame: Up 12 weeks after Treg infusion
Immunologic effects through phenotypical evaluation
Phenotypical evaluation of T cell populations (CD4, CD8, Treg), B and NK cells nuclear cells of Treg-enriched infusion among patients receiving ruxolitinib.
Time frame: Up 12 weeks after Treg infusion
Immunologic effects through immune globulins.
Quantitative immune globulins of Treg-enriched infusion among patients receiving ruxolitinib
Time frame: Up 12 weeks after Treg infusion
Immunologic effects through plasma banking
Plasma banking of Treg-enriched infusion among patients receiving ruxolitinib
Time frame: Up 12 weeks after Treg infusion
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Immunologic effects through additional mononuclear cells.
Storage of additional mononuclear cells of Treg-enriched infusion among patients receiving ruxolitinib
Time frame: Up 12 weeks after Treg infusion
Survival after one year of Treg infusion
Number of patients alive after one year of Treg infusion
Time frame: 1 year after Treg infusion