NCT06991361RecruitingPhase 1

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

Source: ClinicalTrials.gov · Last updated 29 Oct 2026

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Phase (registry): Phase 1
Study type: Interventional
Enrollment: 21 (estimated)
First submitted: 20 May 2025
Start date: 29 May 2026
Primary completion date: 1 May 2029
Lead sponsor: Sarah Nikiforow, MD
NCT number: NCT06991361

What you commit to

Study type: Interventional · Phase 1
Planned participants: 21
From 29 May 2026 to the primary completion date, 1 May 2029
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Concurrent use of methotrexate, azathioprine, or a calcineurin-inhibitor plus sirolimus.
Other investigational agents within 4 weeks prior to enrollment.
Participants with new immunosupprssive medication, extra-corporeal photopheresis or rituximab therapy initiated int he 4 weeks prior to enrollment.
Participants with active malignant relapse or recrudescence of their prior hematologic disorder.

Other illness

Uncontrolled intercurrent illness unrelated to cGVHD.
Participants with psychiatric illness/social situations that would limit compliance with study requirements.

Lab values

Participants with post-transplant exposure to donor lymphocyte infusion, or T-cell or IL-2 targeted medications within 100 days prior to enrollment.

Other

Recipient of umbilical cord blood stem cell graft.
Ongoing prednisone requirement greater than 1 mg/kg/day (or equivalent).
Karnofsky/Lansky performance score less than 40%.
Pregnant patients are excluded.

Who the study is looking for

Recipient of 7-8/8 HLA-matched allogeneic hematopoietic stem cell transplantation or recipient of haploidentical allogenic hematopoietic stem cell transplantation.
Age 2 and up.
Must have steroid-refractory chronic GVHD that is still active despite at least 4 weeks of treatment with low-dose subcutaneous (SC) IL-2.
Stable dose of glucocorticoids for 2 weeks prior to enrollment
no addition or subtraction of other immunosuppressive medications for 4 weeks prior to enrollment.
Must have adequate organ and marrow function.
Ability to understand and willingness to sign a written informed consent form.
Donor who is willing and cleared to donate starting material for manufacture of EVE-Treg.

Age in the registry: 2 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Dana-Farber Cancer Institute Coordinator of this site? Confirm its status	Boston	United States	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.