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New treatment option for Graft Versus Host Disease (cGvHD)
Official title Ex Vivo-Expanded Regulatory T Cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic GVHD
ClinicalTrials.gov ID: NCT06991361
What this study is testing
What is EVE-Treg?
EVE-Treg is an investigational medicine, given as an once-daily, being studied as a potential treatment for graft versus host disease (cgvhd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 and older
You may be able to join if
- Recipient of 7-8/8 HLA-matched allogeneic hematopoietic stem cell transplantation or recipient of haploidentical allogenic hematopoietic stem cell...
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.