Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-24 @ 12:20 PM
NCT ID:
NCT06991361
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT06991361
Study Brief:
Protocol Section:
NCT06991361