RecruitingPhase 1NCT06991361

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

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


Sponsor

Leslie Kean

Enrollment

21 participants

Start Date

May 29, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 2 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called EVE-Treg for people with graft versus host disease (cgvhd). The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALEVE-Treg

Ex Vivo-Expanded (EVE) Regulatory T cells.


Locations(1)

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

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NCT06991361


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