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

Inclusion criteria

• 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 criteria

• 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.