[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100411702":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":41,"centralContacts":30,"locations":46,"responsibleParty":74,"collaborators":77,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":30,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":30,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":30,"overallStatus":49,"whyStopped":30,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},{"fullName":5,"class":6},"Stanford University","OTHER",[8,16,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1","EXPERIMENTAL","The participant will undergo a alpha-beta depleted stem cell transplant using donor cells. The participant's cells will then be manipulated via a T-allo10 cell addback to reach a dose level of 1 X 10\\^5\u002Fkg",[13,14,15],"Biological: Allogeneic Stem Cell Transplant","Device: CliniMACS Prodigy System","Drug: T-allo10 cells addback",{"label":17,"type":10,"description":18,"interventionNames":19},"Cohort 2","The participant will undergo a alpha-beta depleted stem cell transplant using donor cells. The participant's cells will then be manipulated via a T-allo10 cell addback to reach a dose level of 3 X 10\\^5\u002Fkg",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"Cohort 3","The participant will undergo a alpha-beta depleted stem cell transplant using donor cells. The participant's cells will then be manipulated via a T-allo10 cell addback to reach a dose level of 1 X 10\\^6\u002Fkg",[13,14,15],[25,31,36],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"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.",[9,17,21],null,{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":30},"DEVICE","CliniMACS Prodigy System","Device used for production of T-allo10 cells.",[9,17,21],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":30},"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.",[9,17,21],[42],{"name":43,"affiliation":44,"role":45},"Alice Bertaina, MD, PhD","Professor of Pediatrics, Stem Cell Transplantation","PRINCIPAL_INVESTIGATOR",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Lucile Packard Children's Hospital","RECRUITING","Palo Alto","California","94305","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-122.14302,37.44188,{"lat":59,"lon":58},[62,67,70,72],{"name":63,"role":64,"phone":65,"phoneExt":30,"email":66},"Stem Cell and Gene Therapy Clinical Trials Program","CONTACT","650-723-0912","DL-SCTIntakeCoordinators@stanfordchildrens.org",{"name":68,"role":69,"phone":30,"phoneExt":30,"email":30},"Rosa Bacchetta, MD","SUB_INVESTIGATOR",{"name":71,"role":69,"phone":30,"phoneExt":30,"email":30},"David Shyr, MD",{"name":73,"role":69,"phone":30,"phoneExt":30,"email":30},"Rajni Agarwal, MD",{"type":45,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Alice Bertaina","Professor of Pediatrics",[78],{"name":79,"class":6},"California Institute for Regenerative Medicine (CIRM)","100411702","phase-1-stem-cell-transplant-from-donors-after-alpha-beta-cell-depletion-in-children-and-adults-with-t-allo10-cells-addback-100411702",false,"NCT04640987","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","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.","ALL","1 Month","45 Years",{"count":91,"type":92},22,"ESTIMATED","INTERVENTIONAL",[95],"PHASE1","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",[98],"Hematologic Diseases","2026-01-06",{"date":101,"type":102},"2026-01-08","ACTUAL",{"date":104,"type":102},"2021-02-10",{"date":106,"type":92},"2029-03",{"name":108,"class":6},"Porteus, Matthew, MD",1]