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NOT YET RECRUITING
NCT06991361
PHASE1

Ex Vivo-Expanded Regulatory T Cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic GVHD

Sponsor: Leslie Kean

View on ClinicalTrials.gov

Summary

Hematopoietic Stem Cell Transplant (HCT) has been used to treat children and adults who have leukemia, lymphoma and other cancers of blood and immune cells since the 1970s. For many of these forms of cancer, HCT works well. However, HCT can cause serious, sometimes life-threatening complications. One of the most serious and common complications of HCT is graft-versus-host disease (GVHD). GVHD can appear early after the transplant, usually about 3 to 4 weeks after the transplant is given. This is called acute GVHD (aGVHD), because it usually happens over a couple of days. If successfully treated, acute GVHD quickly goes away. Sometimes GVHD happens months after the transplant. Then it is called chronic GVHD (cGVHD), because it happens gradually and goes away slowly. The investigators are doing this study to see if one dose of Ex vivo-Expanded Regulatory T cells (EVE-Treg) can be used together with the daily Interleukin 2 (IL-2) to treat cGVHD, that has not responded to steroid treatment or low-dose IL-2.

Official title: A Phase I Trial of Ex Vivo-Expanded (EVE) Regulatory T Cells in Combination With Low-Dose Interleukin-2 for Steroid-Refractory Chronic Graft-versus-Host-Disease

Key Details

Gender

All

Age Range

2 Years - Any

Study Type

INTERVENTIONAL

Enrollment

21

Start Date

2026-05-01

Completion Date

2030-12-01

Last Updated

2026-03-18

Healthy Volunteers

No

Interventions

BIOLOGICAL

EVE-Treg

Ex Vivo-Expanded (EVE) Regulatory T cells.