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

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.

NCT Number	NCT06991361
Lead Sponsor	Leslie Kean
Conditions	Graft Versus Host Disease (cGvHD)
Enrollment	21 participants
Start Date	2026-05-29
Primary Completion	2029-05-01 (estimated)
Study Completion	2031-05-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-23