[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04640987":3,"trial-entities:NCT04640987":131,"trial-summary:NCT04640987":140},{"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":47,"secondary_outcomes":60,"sex":85,"minimum_age":86,"maximum_age":87,"healthy_volunteers":88,"eligibility_criteria":89,"std_ages":97,"locations":100,"central_contacts":123,"overall_officials":124,"references":129,"see_also_links":130},"NCT04640987","IRB-58549","Stem Cell Transplant From Donors After Alpha Beta Cell Depletion in Children and Adults With T-allo10 Cells Addback","Phase 1\u002F1b Study of T-allo10 Infusion After HLA-Partially Matched Related or Unrelated TCR αβ+ T-cell\u002F CD19+ B-cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation (αβ Depleted-HSCT) in Children and Young Adults Affected by Hematologic Malignancies","RECRUITING","2029-03","2026-01","2026-01-08","2021-02-10","Porteus, Matthew, MD","OTHER",true,"The purpose of this study is to determine the safety of a cell therapy, T-allo10, after αβdepleted-HSCT in the hopes that it will boost the adaptive immune reconstitution of the patient while sparing the risk of developing severe Graft-versus-Host Disease (GvHD).\n\nThe primary objective of Phase 1a is to determine the recommended Phase 2 dose (RP2D) administered after infusion of αβdepleted-HSCT in children and young adults with hematologic malignancies.\n\nA Phase 1b extension will occur after dose escalation, enrolling at the RP2D for the T-allo10 cells determined in the Phase 1 portion to evaluate the safety and efficacy of infusion of T-allo10 after receipt of αβdepleted-HSCT. Additionally, Phase 1b aims to explore improvements in immune reconstitution.\n\nAll participants on this study must be enrolled on another study: NCT04249830",null,[19],"Hematologic Diseases",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE1",{"count":26,"type":27},22,"ESTIMATED",[29,37,42],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BIOLOGICAL","Allogeneic Stem Cell Transplant","The allogeneic stem cell transplant involves transferring the stem cells from a healthy person (donor) to the participant via infusion.",[34,35,36],"Cohort 1","Cohort 2","Cohort 3",{"type":38,"name":39,"description":40,"armGroupLabels":41},"DEVICE","CliniMACS Prodigy System","Device used for production of T-allo10 cells.",[34,35,36],{"type":43,"name":44,"description":45,"armGroupLabels":46},"DRUG","T-allo10 cells addback","T-allo10 cells are made by manipulating the participant's stem cell donor's white blood cells (CD4+ T cells) in the presence of their (participant's) CD14+ monocytes.",[34,35,36],[48,52,56],{"measure":49,"description":50,"timeFrame":51},"Recommended Phase 2 Dose (RP2D) of T-allo10 in Phase 1a","RP2D was determined by testing 3 different escalating doses (1x10\\^5, 3x10\\^5 and 1x10\\^6 cells\u002FKg recipient body weight) in dose escalation cohorts 1 to 3 with 3 to 6 participants each. RP2D reflects the acceptable dose levels that did not cause a Dose-Limiting Toxicity (DLT) in ≥33% of participants and resulted in success with response in \\>83% of participants. DLTs were defined as Grade IV aGvHD post T-allo10 infusion; any grade 3 or 4 related TEAE; any grade 3 or 4 suspected AE. Success with response was defined as achieving CD4+ IR by Day +60 (+\u002F- 10 days) after αβdepleted-HSCT.","Up to 28 days after infusion of T-allo10 for each dosing cohort and Day +60 (+\u002F- 10 days) after αβdepleted-HSCT",{"measure":53,"description":54,"timeFrame":55},"Number of participants with absence of dose-limiting toxicity (DLT)","Grade IV aGvHD post T-allo10 infusion; any grade 3 or 4 related treatment emergent adverse events (TEAE); any grade 3 or 4 suspected AE","Assessed at 28 days (after infusion of T-allo10)",{"measure":57,"description":58,"timeFrame":59},"Number of participants who reach immune reconstitution (IR) threshold","IR (a surrogate of reduced risk of leukemia recurrence) is defined reaching the threshold of 50CD3+CD4+T-cells\u002Fµl by Day+60 (+\u002F-10days).","Up to Day 60 (+\u002F- 10 days) after αβdepleted-HSCT",[61,64,68,71,75,78,81],{"measure":62,"timeFrame":63},"Number of participants with ≥grade 3 adverse event related to T-allo10 infusion","Through 1 year after αβdepleted-HSCT",{"measure":65,"description":66,"timeFrame":67},"Number of participants with grade II-IV aGvHD","Cumulative incidence of acute GvHD (graded as II-IV using the Magic criteria)","Assessed at day 90 and day 180 after αβdepleted-HSCT",{"measure":69,"description":70,"timeFrame":67},"Number of participants with grade III-IV aGvHD","Cumulative incidence of acute GvHD (graded as III-IV using the Magic criteria)",{"measure":72,"description":73,"timeFrame":74},"Number of participants with cGvHD","Chronic GvHD is graded according to the NIH Consensus Conference criteria","Assessed at 1 year after αβdepleted-HSCT",{"measure":76,"description":77,"timeFrame":74},"Number of participants who achieved leukemia-free survival","Leukemia-free survival defined as at the time of enrollment to disease relapse or death from any cause.",{"measure":79,"description":80,"timeFrame":74},"Number of participants with disease relapse","Disease relapse is defined as the return of signs and symptoms of a disease after a remission.",{"measure":82,"description":83,"timeFrame":84},"Non-relapse mortality","Non-relapse mortality is defined as death not preceded by recurrent primary malignancy","Assessed at Day 90, 1 year after αβdepleted-HSCT","ALL","1 Month","45 Years",false,{"inclusion":90,"exclusion":95,"raw_text":96},[91,92,93,94],"1\\. Age \\> 1 months (with minimum weight of 10 Kg) and \\\u003C 45 years.","2\\. Patients deemed eligible for allogeneic HSCT under the originating study, NCT 04249830","3\\. Patients with life-threatening hematological malignancies for which HSCT has been recommended:","4\\. All subjects ≥ 18 years of age must be able to give informed consent, or adults lacking capacity to consent must have a LAR available to provide consent. For subjects \\\u003C18 years old their LAR (i.e. parent or guardian) must give informed consent. Pediatric subjects will be included in age appropriate discussion and verbal assent will be obtained for those \\> 7 years of age, when appropriate.",[],"Inclusion Criteria prior to enrollment:\n\n* 1\\. Age \\> 1 months (with minimum weight of 10 Kg) and \\\u003C 45 years.\n* 2\\. Patients deemed eligible for allogeneic HSCT under the originating study, NCT 04249830\n* 3\\. Patients with life-threatening hematological malignancies for which HSCT has been recommended:\n\n  1. High-risk ALL in 1st CR, ALL in 2nd or subsequent CR;\n  2. High-risk AML in 1st CR, AML in 2nd or subsequent CR;\n  3. Myelodysplastic syndrome;\n  4. JMML (Juvenile myelomonocytic leukemia);\n  5. Non-Hodgkin lymphomas in 2nd or subsequent CR;\n  6. Other hematologic malignancies eligible for stem cell transplantation per institutional standard.\n* 4\\. All subjects ≥ 18 years of age must be able to give informed consent, or adults lacking capacity to consent must have a LAR available to provide consent. For subjects \\\u003C18 years old their LAR (i.e. parent or guardian) must give informed consent. Pediatric subjects will be included in age appropriate discussion and verbal assent will be obtained for those \\> 7 years of age, when appropriate.\n\nInclusion criteria prior to T-allo10 infusion:\n\n1. Patient already received αβdepleted-HSCT and has myeloid engraftment.\n2. Absence of active grade II aGvHD requiring \\>0.5 mg\u002FKg of steroids or any diagnosis of grade III\u002FIVaGvHD.\n\nExclusion Criteria prior to MNC collection for Tallo-10 manufacturing.:\n\n1. Not eligible to receive HSCT on NCT04249830\n2. Received another investigational agent within 30 days of enrollment.\n3. Pregnancy (positive serum or urine beta-HCG) within 7 days of MNC donation.\n4. Patient or donor is not willing or able to undergo an additional non-mobilized apheresis for collection of MNC prior to donation of cells for participation in NCT04249830.",[98,99],"CHILD","ADULT",[101],{"facility":102,"status":8,"city":103,"state":104,"zip":105,"country":106,"contacts":107,"geoPoint":120},"Lucile Packard Children's Hospital","Palo Alto","California","94305","United States",[108,113,116,118],{"name":109,"role":110,"phone":111,"email":112},"Stem Cell and Gene Therapy Clinical Trials Program","CONTACT","650-723-0912","DL-SCTIntakeCoordinators@stanfordchildrens.org",{"name":114,"role":115},"Rosa Bacchetta, MD","SUB_INVESTIGATOR",{"name":117,"role":115},"David Shyr, MD",{"name":119,"role":115},"Rajni Agarwal, MD",{"lat":121,"lon":122},37.44188,-122.14302,[],[125],{"name":126,"affiliation":127,"role":128},"Alice Bertaina, MD, PhD","Professor of Pediatrics, Stem Cell Transplantation","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":132,"biomarkers":139},[133,134,135,136,137,138],"Acute Lymphoblastic Leukemia","Acute Myeloid Leukemia","Hematologic Neoplasm","Juvenile Myelomonocytic Leukemia","Myelodysplastic Syndrome","Non-Hodgkin Lymphoma",[],{"nct_id":4,"found":15,"summary":141,"prompt_version":151},{"design":142,"status":143,"heading":144,"summary":145,"follow_up":146,"word_count":147,"commitments":148,"compensation":149,"drugs_mentioned":150},"This is an interventional study, meaning participants will receive a specific treatment. It aims to determine the recommended dose of T-allo10 and assess its safety and effectiveness.","completed","Stem Cell Transplant with T-allo10 for Hematologic Diseases","This study is testing a new cell therapy called T-allo10, given after an allogeneic stem cell transplant (a transplant using stem cells from a healthy donor). The goal is to see if T-allo10 can help your immune system recover better after the transplant, while also reducing the risk of a serious complication called Graft-versus-Host Disease (GvHD). Researchers want to find the safest and most effective dose of T-allo10. This study is for children and young adults, aged 1 month to 45 years, who have life-threatening blood cancers and are eligible for a stem cell transplant. The study is currently unclear on its recruitment status and plans to enroll 22 participants.","Safety and immune recovery will be assessed up to 60 days after the stem cell transplant.",110,"Not specified in the trial record.","Not stated in the trial record.",[31],"v2"]