[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06991361":3,"trial-entities:NCT06991361":97,"trial-summary:NCT06991361":101},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":37,"secondary_outcomes":42,"sex":43,"minimum_age":44,"maximum_age":17,"healthy_volunteers":45,"eligibility_criteria":46,"std_ages":69,"locations":73,"central_contacts":92,"overall_officials":94,"references":95,"see_also_links":96},"NCT06991361","IRB00025318","Ex Vivo-Expanded Regulatory T Cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic GVHD","A Phase I Trial of Ex Vivo-Expanded (EVE) Regulatory T Cells in Combination With Low-Dose Interleukin-2 for Steroid-Refractory Chronic Graft-versus-Host-Disease","RECRUITING","2031-05-01","2026-07","2026-07-23","2026-05-29","Leslie Kean","OTHER",true,"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. However, HCT can cause serious, sometimes life-threatening complications.\n\nOne of the most serious and common complications of HCT is graft-versus-host disease (GVHD). GVHD can appear early after the transplant, usually about 3 to 4 weeks after the transplant is given. This is called acute GVHD (aGVHD), because it usually happens over a couple of days. If successfully treated, acute GVHD quickly goes away. Sometimes GVHD happens months after the transplant. Then it is called chronic GVHD (cGVHD), because it happens gradually and goes away slowly.\n\nThe investigators are doing this study to see if one dose of Ex vivo-Expanded Regulatory T cells (EVE-Treg) can be used together with the daily Interleukin 2 (IL-2) to treat cGVHD, that has not responded to steroid treatment or low-dose IL-2.",null,[19],"Graft Versus Host Disease (cGvHD)",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE1",{"count":26,"type":27},21,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BIOLOGICAL","EVE-Treg","Ex Vivo-Expanded (EVE) Regulatory T cells.",[34,35,36],"Dose Level A","Dose Level B","Dose Level C",[38],{"measure":39,"description":40,"timeFrame":41},"Safety of EVE-Treg","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","5 weeks",[],"ALL","2 Years",false,{"inclusion":47,"exclusion":56,"raw_text":68},[48,49,50,51,52,53,54,55],"Recipient of 7-8\u002F8 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.",[57,58,59,60,61,62,63,64,65,66,67],"Recipient of umbilical cord blood stem cell graft.","Ongoing prednisone requirement greater than 1 mg\u002Fkg\u002Fday (or equivalent).","Karnofsky\u002FLansky 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\u002Fsocial situations that would limit compliance with study requirements.","Pregnant patients are excluded.","Inclusion Criteria:\n\n* Recipient of 7-8\u002F8 HLA-matched allogeneic hematopoietic stem cell transplantation or recipient of haploidentical allogenic hematopoietic stem cell transplantation.\n* Age 2 and up.\n* Must have steroid-refractory chronic GVHD that is still active despite at least 4 weeks of treatment with low-dose subcutaneous (SC) IL-2.\n* Stable dose of glucocorticoids for 2 weeks prior to enrollment\n* no addition or subtraction of other immunosuppressive medications for 4 weeks prior to enrollment.\n* Must have adequate organ and marrow function.\n* Ability to understand and willingness to sign a written informed consent form.\n* Donor who is willing and cleared to donate starting material for manufacture of EVE-Treg.\n\nExclusion Criteria:\n\n* Recipient of umbilical cord blood stem cell graft.\n* Ongoing prednisone requirement greater than 1 mg\u002Fkg\u002Fday (or equivalent).\n* Karnofsky\u002FLansky performance score less than 40%.\n* Concurrent use of methotrexate, azathioprine, or a calcineurin-inhibitor plus sirolimus.\n* Other investigational agents within 4 weeks prior to enrollment.\n* Participants with post-transplant exposure to donor lymphocyte infusion, or T-cell or IL-2 targeted medications within 100 days prior to enrollment.\n* Participants with new immunosupprssive medication, extra-corporeal photopheresis or rituximab therapy initiated int he 4 weeks prior to enrollment.\n* Participants with active malignant relapse or recrudescence of their prior hematologic disorder.\n* Uncontrolled intercurrent illness unrelated to cGVHD.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant patients are excluded.",[70,71,72],"CHILD","ADULT","OLDER_ADULT",[74],{"facility":75,"status":8,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":89},"Dana-Farber Cancer Institute","Boston","Massachusetts","02115","United States",[81,86],{"name":82,"role":83,"phone":84,"email":85},"Brandi Bratrude","CONTACT","617-919-2197","brandi.bratrude@childrens.harvard.edu",{"name":87,"role":88},"Sarah Nikiforow, MD, PhD","PRINCIPAL_INVESTIGATOR",{"lat":90,"lon":91},42.35843,-71.05977,[93],{"name":82,"role":83,"phone":84,"email":85},[],[],[],{"nct_id":4,"conditions":98,"biomarkers":100},[99],"Graft Versus Host Disease",[],{"nct_id":4,"found":15,"summary":102,"prompt_version":112},{"design":103,"status":104,"heading":105,"summary":106,"follow_up":107,"word_count":108,"commitments":109,"compensation":110,"drugs_mentioned":111},"This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 21 participants.","completed","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.","The safety of EVE-Treg will be measured at 5 weeks after treatment.",102,"Not specified in the trial record.","Not stated in the trial record.",[31],"v2"]