Status:
NOT_YET_RECRUITING
Ex Vivo-Expanded Regulatory T Cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic GVHD
Lead Sponsor:
Leslie Kean
Conditions:
Graft Versus Host Disease (cGvHD)
Eligibility:
All Genders
2+ years
Phase:
PHASE1
Brief 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 ...
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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT06991361
Start Date
September 1 2025
End Date
December 1 2028
Last Update
May 31 2025
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