[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07285668":3,"trial-entities:NCT07285668":155,"trial-summary:NCT07285668":167},{"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":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":40,"secondary_outcomes":48,"sex":88,"minimum_age":89,"maximum_age":90,"healthy_volunteers":91,"eligibility_criteria":92,"std_ages":123,"locations":126,"central_contacts":136,"overall_officials":142,"references":150,"see_also_links":151},"NCT07285668","2025-1405","Prophylactic TCRaB+ and CD19+ Depleted Donor Lymphocyte Infusion After Allogeneic Stem Cell Transplant in High-Risk Patients With Hematologic Malignancies","Phase I Study of Prophylactic TCRαβ+ and CD19+ Depleted Donor Lymphocyte Infusion After Allogeneic Stem Cell Transplant in High-Risk Patients With Hematologic Malignancies","RECRUITING","2031-02","2026-07","2026-07-24","2026-02-26","University of Wisconsin, Madison","OTHER",true,"This study is being done to assess the safety and determine the maximum tolerable dose (MTD) of TCRαβ+\u002FCD19+-depleted Donor Lymphocyte Infusion (αβT\u002FB dep-DLI) after allogeneic stem cell transplant (allo-SCT) in highrisk patients with hematologic malignancies.","Primary Objectives\n\n* To assess safety of prophylactic TCRαβ+\u002FCD19+ depleted donor lymphocyte infusion (αβT\u002FB dep-DLI) after allogeneic stem cell transplant (allo-SCT) in high-risk patients with hematologic malignancies\n* To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) of αβT\u002FB dep-DLI\n\nSecondary Objectives\n\n* To assess the feasibility of αβT\u002FB dep-DLI\n* To assess additional safety parameters after αβT\u002FB dep-DLI\n* To assess the efficacy of αβT\u002FB dep-DLI\n\nFor the dose escalation phase: Maximum Tolerated Dose (MTD) and Maximum Administered Dose (MAD) is defined as the highest dose level where less than 2 of 6 participants experience a dose limiting toxicity (DLT).\n\nEach dose level will be followed for DLTs until day 28 post donor lymphocyte infusion (DLI). Starting at dose level 1:\n\n* If 0 of 3 participants experiences DLT, increase to next dose level for next 3 participants.\n* If 1 of 3 participants experience DLT, enroll 3 participants at same dose level.\n\n  * If no additional DLTs (1 of 6), move on to next dose level.\n  * If 2 of 6 participants experience DLT, enroll 3 participants into lower dose level.\n* If 0 or 1 participants experience DLT at lower level, this will be the MTD.\n\nOnce the MTD or MAD is determined, an expansion cohort will be enrolled into that dose level.\n\nAll participants will be followed for 2 years after DLI.",[19],"Hematologic Malignancies",[21,22],"allogeneic donor","Lymphocyte Infusion","INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},38,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DEVICE","Allogeneic donor TCRαβ+\u002FCD19+ cell-depleted peripheral blood mononuclear cells","Single intravenous dose of allogeneic donor TCRαβ+\u002FCD19+ cell-depleted peripheral blood mononuclear cells (i.e., αβT\u002FB dep-DLI), where the dose is based on the natural killer (NK) cell (CD3-CD56+) content in the DLI product. Each participant will receive one of four DLI doses depending upon cohort to which the participant is enrolled.",[36,37,38,39],"Dose Escalation Cohort Level -1","Dose Escalation Cohort Level 1","Dose Escalation Cohort Level 2","Dose Escalation Cohort Level 3",[41,45],{"measure":42,"description":43,"timeFrame":44},"Incidence of Adverse Events (AEs) from DLI to day 28 post-DLI","To assess safety of prophylactic TCRαβ+\u002FCD19+ depleted donor lymphocyte infusion (αβT\u002FB dep-DLI) after allogeneic stem cell transplant (allo-SCT) in high-risk patients with hematologic malignancies, incidence of AEs will be reported.","up to day 28 post-DLI (approximately day 63 on study)",{"measure":46,"description":47,"timeFrame":44},"Maximum Tolerated Dose or Maximum Administered Dose","MTD\u002FMAD defined as the highest dose level at which less than 2 of 6 participants experience a DLT.",[49,52,55,58,62,66,69,72,75,78,81,84],{"measure":50,"description":51,"timeFrame":44},"Incidence of grade II-IV acute Graft-versus-Host Disease (aGVHD) after αβT\u002FB dep-DLI","To assess additional safety parameters after allo-SCT in high-risk patients with hematologic malignancies, Incidence of grade II-IV aGVHD after αβT\u002FB dep-DLI will be reported.",{"measure":53,"description":54,"timeFrame":44},"Cumulative incidence of severe grade III-IV aGVHD after αβT\u002FB dep-DLI","To assess additional safety parameters after allo-SCT in high-risk patients with hematologic malignancies, cumulative incidence of severe grade III-IV aGVHD after αβT\u002FB dep-DLI will be reported.",{"measure":56,"description":57,"timeFrame":44},"Chronic Graft-versus-Host Disease (GVHD) incidence after αβT\u002FB dep-DLI","To assess additional safety parameters after allo-SCT in high-risk patients with hematologic malignancies, chronic GVHD incidence after αβT\u002FB dep-DLI will be reported.",{"measure":59,"description":60,"timeFrame":61},"Efficacy assessed by 1 year Progression Free Survival (PFS)","To assess the efficacy of prophylactic αβT\u002FB dep-DLI after allo-SCT in high-risk patients with hematologic malignancies, 1 year PFS will be reported.","up to 1 year",{"measure":63,"description":64,"timeFrame":65},"Efficacy Assessed by Non-Relapse Mortality","To assess the efficacy of prophylactic αβT\u002FB dep-DLI after allo-SCT in high-risk patients with hematologic malignancies, non-relapse mortality will be reported.","up to 2 years",{"measure":67,"description":68,"timeFrame":65},"Efficacy Assessed by Overall Survival","To assess the efficacy of prophylactic αβT\u002FB dep-DLI after allo-SCT in high-risk patients with hematologic malignancies, overall survival will be reported.",{"measure":70,"description":71,"timeFrame":65},"Efficacy Assessed by Incidence of Cytomegalovirus (CMV) Reactivation","To assess the efficacy of prophylactic αβT\u002FB dep-DLI after allo-SCT in high-risk patients with hematologic malignancies, incidence of CMV Reactivation will be reported.",{"measure":73,"description":74,"timeFrame":65},"Efficacy Assessed by Incidence of Fungal Infection","To assess the efficacy of prophylactic αβT\u002FB dep-DLI after allo-SCT in high-risk patients with hematologic malignancies, incidence of fungal infections will be reported.",{"measure":76,"description":77,"timeFrame":65},"Efficacy Assessed by Incidence of Full Chimerism (CD3 compartment)","To assess the efficacy of prophylactic αβT\u002FB dep-DLI after allo-SCT in high-risk patients with hematologic malignancies, incidence of full chimerism will be reported.",{"measure":79,"description":80,"timeFrame":65},"Efficacy Assessed by Immunoglobulin Levels","To assess the efficacy of prophylactic αβT\u002FB dep-DLI after allo-SCT in high-risk patients with hematologic malignancies, quantitative immunoglobulin levels will be reported.",{"measure":82,"description":83,"timeFrame":65},"Efficacy Assessed by Lymphocyte Panel Analysis","To assess the efficacy of prophylactic αβT\u002FB dep-DLI after allo-SCT in high-risk patients with hematologic malignancies, lymphocyte subset panel analysis will be conducted and reported.",{"measure":85,"description":86,"timeFrame":87},"Feasibility assessed by percentage of enrolled participants who are able to receive depleted DLI","To assess the feasibility of prophylactic αβT\u002FB dep-DLI after allo-SCT in high-risk patients with hematologic malignancies, the percentage of enrolled participants who are able to receive depleted DLI will be reported.","up to approximately 35 days","ALL","18 Years","80 Years",false,{"inclusion":93,"exclusion":114,"raw_text":122},[94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113],"Patients with high-risk myeloid or lymphoid malignancies determined to be eligible to undergo allo-SCT including but not limited to the conditions listed below. These criteria apply at the disease diagnosis or any time prior to the cyto-reductive therapy given before the planned conditioning:","Refractory acute myelogenous (AML) or lymphoid leukemia (ALL)","Relapsed AML or ALL","AML in European LeukemiaNet (ELN) high risk per cytogenetic and mutation","Any patients with minimal residual disease (MRD+) disease by flow cytometry or with active disease (not in complete remission (CR)) prior to allo-SCT","Myelodysplastic syndromes (MDS) with 5% or more blasts at initial diagnosis, or anytime during their treatment prior to allo-SCT.","Myelodysplastic syndrome (MDS) high risk or very high risk per Revised International Prognostic Scoring System (IPSS-R) or Molecular International Prognostic Scoring System (IPSS-M)","Chronic myelogenous leukemia (CML) in chronic phase failed 3 or more treatments, in accelerated or blast phase","High risk primary myelofibrosis (PMF) per Dynamic International Prognostic Scoring System (DIPSS)-plus or Mutation-enhanced International Prognostic Scoring System for Transplant-age Patients (MIPSS70+)","PMF in accelerated or blast phase","Recurrent or refractory malignant lymphoma or Hodgkin's disease with less than a partial response at transplant","High risk chronic lymphocytic leukemia defined as no response or stable disease to the most recent treatment regimen","Other high risk hematologic malignancies for which allo-SCT is deemed clinically necessary per PI and based on institutional standards","The donor for the allo-SCT must be:","Related AND","Matched OR mismatched OR haploidentical at HLA-A, -B, -C, and -DRB1 by molecular methods","ECOG performance score of 0-2","Ability to understand and willingness to sign written informed consent document","Willing to comply with all study procedures and be available for the duration of the study","Individuals in sexual relationships that could result in pregnancy or impregnation of their partner must use an acceptable method of contraception§ from enrollment until 4 weeks after completing study treatment.",[115,116,117,118,119,120,121],"Creatinine ≥ 2.0 mg\u002FdL","SGOT and SGPT ≥ 5 x ULN. Liver biopsy per clinician discretion.","Bilirubin ≥ 3 x ULN (unless Gilbert's syndrome)","DLCO \\\u003C 50% corrected for hemoglobin","Left ventricular ejection fraction or shortening fraction \\\u003C 40%","Patients with uncontrolled intercurrent illness","Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements","Inclusion Criteria:\n\n* Patients with high-risk myeloid or lymphoid malignancies determined to be eligible to undergo allo-SCT including but not limited to the conditions listed below. These criteria apply at the disease diagnosis or any time prior to the cyto-reductive therapy given before the planned conditioning:\n\n  * Refractory acute myelogenous (AML) or lymphoid leukemia (ALL)\n  * Relapsed AML or ALL\n  * AML in European LeukemiaNet (ELN) high risk per cytogenetic and mutation\n  * Any patients with minimal residual disease (MRD+) disease by flow cytometry or with active disease (not in complete remission (CR)) prior to allo-SCT\n  * Myelodysplastic syndromes (MDS) with 5% or more blasts at initial diagnosis, or anytime during their treatment prior to allo-SCT.\n  * Myelodysplastic syndrome (MDS) high risk or very high risk per Revised International Prognostic Scoring System (IPSS-R) or Molecular International Prognostic Scoring System (IPSS-M)\n  * Chronic myelogenous leukemia (CML) in chronic phase failed 3 or more treatments, in accelerated or blast phase\n  * High risk primary myelofibrosis (PMF) per Dynamic International Prognostic Scoring System (DIPSS)-plus or Mutation-enhanced International Prognostic Scoring System for Transplant-age Patients (MIPSS70+)\n  * PMF in accelerated or blast phase\n  * Recurrent or refractory malignant lymphoma or Hodgkin's disease with less than a partial response at transplant\n  * High risk chronic lymphocytic leukemia defined as no response or stable disease to the most recent treatment regimen\n  * Other high risk hematologic malignancies for which allo-SCT is deemed clinically necessary per PI and based on institutional standards\n* The donor for the allo-SCT must be:\n\n  * Related AND\n  * Matched OR mismatched OR haploidentical at HLA-A, -B, -C, and -DRB1 by molecular methods\n* ECOG performance score of 0-2\n* Ability to understand and willingness to sign written informed consent document\n* Willing to comply with all study procedures and be available for the duration of the study\n* Individuals in sexual relationships that could result in pregnancy or impregnation of their partner must use an acceptable method of contraception§ from enrollment until 4 weeks after completing study treatment.\n\nExclusion Criteria:\n\n• Poor organ function as follows (According to the pre-transplant workups results):\n\n* Creatinine ≥ 2.0 mg\u002FdL\n* SGOT and SGPT ≥ 5 x ULN. Liver biopsy per clinician discretion.\n* Bilirubin ≥ 3 x ULN (unless Gilbert's syndrome)\n* DLCO \\\u003C 50% corrected for hemoglobin\n* Left ventricular ejection fraction or shortening fraction \\\u003C 40%\n\nNOTE: Exceptions to the above organ function exclusion criteria are allowable only with assent of the PI since the risks and benefits must be addressed for patients with potentially incurable hematologic malignancies. Such exceptions will be clearly documented in the subject's research record and will not be considered a deviation.\n\n* Patients with uncontrolled intercurrent illness\n* Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements",[124,125],"ADULT","OLDER_ADULT",[127],{"facility":128,"status":8,"city":129,"state":130,"zip":131,"country":132,"geoPoint":133},"UW Carbone Cancer Center","Madison","Wisconsin","53792","United States",{"lat":134,"lon":135},43.07305,-89.40123,[137],{"name":138,"role":139,"phone":140,"email":141},"Cancer Connect","CONTACT","800-622-8922","clinicaltrials@cancer.wisc.edu",[143,147],{"name":144,"affiliation":145,"role":146},"Jacques Galipeau, MD, FRCP(C)","UW School of Medicine and Public Health","STUDY_DIRECTOR",{"name":148,"affiliation":128,"role":149},"Hongtao Liu, MD, PhD","PRINCIPAL_INVESTIGATOR",[],[152],{"label":153,"url":154},"Stem Cell and Regenerative Medicine Center","https:\u002F\u002Fstemcells.wisc.edu\u002Fstaff\u002Fgalipeau-jacques\u002F",{"nct_id":4,"conditions":156,"biomarkers":166},[157,158,159,160,161,162,163,164,165],"Acute Lymphoblastic Leukemia","Acute Myeloid Leukemia","Chronic Lymphocytic Leukemia","Chronic Myeloid Leukemia, BCR-ABL1 Positive","Hematologic Neoplasm","Hodgkin's Granuloma","Lymphoma","Myelodysplastic Syndrome","Primary Myelofibrosis",[],{"nct_id":4,"found":15,"summary":168,"prompt_version":178},{"design":169,"status":170,"heading":171,"summary":172,"follow_up":173,"word_count":174,"commitments":175,"compensation":176,"drugs_mentioned":177},"This is an interventional study with a planned enrollment of 38 participants. It will involve finding the maximum tolerated dose of the treatment.","completed","Prophylactic TCRαβ+\u002FCD19+ Depleted Donor Lymphocyte Infusion After Allogeneic Stem Cell Transplant","This study is testing a treatment called TCRαβ+\u002FCD19+ cell-depleted peripheral blood mononuclear cells (αβT\u002FB dep-DLI) given after an allogeneic stem cell transplant (allo-SCT). This treatment aims to help high-risk patients with blood cancers (hematologic malignancies). The main goals are to see how safe αβT\u002FB dep-DLI is and to find the highest dose that can be given without causing too many side effects. The study plans to enroll 38 participants aged 18 to 80 years old who have high-risk blood cancers like refractory acute myeloid leukemia (AML) or acute lymphoid leukemia (ALL). This study is currently unclear on its status, meaning it may not be actively recruiting yet.","All participants will be followed for 2 years after receiving the donor lymphocyte infusion (DLI).",107,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]