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EVE-Treg for Steroid-Refractory Chronic GVHD

This study is testing a treatment called Ex Vivo-Expanded Regulatory T cells (EVE-Treg) for people with chronic graft-versus-host disease (cGVHD) that hasn't improved with standard low-dose IL-2 (interleukin-2) treatment. cGVHD is a serious complication that can happen after a stem cell transplant, where the new immune cells attack your body. Researchers want to see if EVE-Treg is safe. You might be able to join if you are at least 2 years old, have received a specific type of stem cell transplant, and your cGVHD is still active despite at least four weeks of low-dose IL-2. The study plans to enroll 21 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 21 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The safety of EVE-Treg will be measured at 5 weeks after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06991361

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

Recruiting
PHASE1Ages 2+InterventionalTreatment
Leslie Kean
~21 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:EVE-Treg

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of EVE-Treg
Measured over 5 weeks

Conditions

Graft Versus Host Disease (cGvHD)

Explore related trials

Graft Versus Host Disease

Where it's being run

1 sites across 1 states
Massachusetts1

Who to contact

Brandi Bratrude
[email protected]
617-919-2197
Email the study team

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Eligibility criteria

Inclusion

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.

Exclusion

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%.
Concurrent use of methotrexate, azathioprine, or a calcineurin-inhibitor plus sirolimus.
Other investigational agents within 4 weeks prior to enrollment.
Participants with post-transplant exposure to donor lymphocyte infusion, or T-cell or IL-2 targeted medications within 100 days 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.
Uncontrolled intercurrent illness unrelated to cGVHD.
Participants with psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant patients are excluded.

What this trial measures

  • Safety of EVE-Treg5 weeks

    Safety of EVE-Treg, in combination with physician-prescribed daily low-dose IL-2, for the treatment of chronic GVHD refractory to steroids and low-dose IL-2. Safety will be based on adverse events at each Dose Level of EVE-Treg