[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546340":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":19,"responsibleParty":37,"collaborators":7,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":7,"eligibilityCriteria":47,"healthyVolunteers":43,"sex":48,"minAge":7,"maxAge":49,"enrollmentInfo":7,"targetDuration":7,"studyType":50,"phases":7,"briefSummary":51,"conditions":52,"keywords":55,"overallStatus":22,"whyStopped":7,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":7,"completionDateStruct":7,"leadSponsor":62,"locationsCount":63},{"fullName":5,"class":6},"University of Texas Southwestern Medical Center","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DEVICE","CliniMACS® CD34 TCR Alpha\u002FBeta","CliniMACS System uses an automated antibody\u002Fmagnetic beads column system that allows efficient depletion of TCRαβ and CD19+ cells without relevant loss of cell viability. Hematopoietic stem cells are retained in sufficient numbers to permit engraftment and hematopoietic reconstitution. Humanitarian Exemption IDE approval has been obtained for CD34+ cell selection as a method of T-cell depletion.",[14],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Victor Aquino, MD","CONTACT","214-648-3896","Victor.Aquino@utsouthwestern.edu",[20],{"facility":21,"status":22,"city":23,"state":24,"zip":25,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":34},"Children's Medical Center - Dallas","AVAILABLE","Dallas","Texas","75235","United States","US",{"type":29,"coordinates":30},"Point",[31,32],-96.80667,32.78306,{"lat":32,"lon":31},[35],{"name":15,"role":16,"phone":36,"phoneExt":7,"email":18},"214-456-2382",{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"SPONSOR_INVESTIGATOR","Victor Aquino","Professor","100546340","treatment-use-of-the-clinimacs-cd34-tcr-alphabeta-for-allogenic-transplant-expanded-access-use-100546340",false,"NCT06393660","Treatment Use of the CliniMACS® CD34 TCR Alpha\u002FBeta for Allogenic Transplant (Expanded Access Use)","Treatment Use of the CliniMACS® CD34 TCR Alpha\u002FBeta to Prepare Cells for an Unlabeled Indication Using an HLA-Compatible Related or Unrelated Donor for Allogenic Transplant","Recipient Inclusion Criteria:\n\n* Age less than 22 years of age\n* No available genotypically matched related donor (sibling)\n* Availability of a suitable donor and graft source\n* Haploidentical related mobilized peripheral blood cells\n* 9\u002F10 or 10\u002F10 allele matched (HLA-A, -B, -C, -DRB1, -DQB1) volunteer unrelated donor mobilized peripheral blood cells\n\nDonor Inclusion Criteria:\n\n* Matching as described in the Recipient and Donor Suitability Criteria\n* Size and vascular access appropriate by center standard for peripheral blood stem cell (PBSC) collection. Donors with inadequate peripheral access will require placement of an apheresis catheter for collection.\n* Must meet appropriate screening\u002Feligibility requirements:\n\n  * Haploidentical matched family members: screened by center health screens and found to be eligible.\n  * Unrelated donors: meet suitability criteria to donate PBSC\n  * HIV negative\n  * Not pregnant or lactating\n  * Recipient must not have high-level donor specific anti-HLA antibodies according to institutional practices.\n  * Must agree to donate PBSC\n  * Must give informed consent\n\nRecipient Suitability:\n\n\\- Adequate organ functioning as demonstrated by:\n\n* MUGA ≥ 50% or ECHO \\>30%\n* 24-hour Creatinine Clearance or Glofil ≥ 50 ml\u002Fmin or Serum Creatinine ≤2 times the upper limit of normal\n* DLCO \\> 65% of predicted value. FEV1 \\>65% of predicted\n* AST \u002F ALT ≤ 2.5 and\u002For Bilirubin ≤ 1.5 times the upper limit of normal\n* Pregnancy test negative\n* HIV 1 \u002F 2 (HIV screen) negative with a negative qualitative HIV PCR.\n* HTLV I negative\n* RPR or VDRL negative\n* RVP (Respiratory Viral PCR) with a negative result\n* Positive hepatitis testing does not make the patient ineligible. Hepatitis results will be evaluated on a case-by-case basis by the transplant physician to determine donor suitability\u002Feligibility.\n\nDonor Suitability:\n\n\\- Allowed Donor Sources\n\n* Fully matched sibling donors are not allowed.\n* Unrelated donors. HLA typing of at least 10 alleles is required. Donor must be matched at 9\u002F10 or 10\u002F10 alleles (HLA-A, -B, -C, -DRB1, -DQB1). Haploidentical matched family members. Minimum match level full haploidentical (at least 5\u002F10; HLA-A, -B, -C, -DRB1, -DQB1 alleles), but use of haploidentical donors with extra matches (e.g., 6, 7, or 8\u002F10) encouraged.\n* Cord blood is not allowed as a stem cell source on this IDE.\n\nRecipient and Donor Exclusion Criteria:\n\n* Pregnant or lactating females are ineligible as the risk to unborn children and infants is unknown\n* Presence of life-threatening, uncontrolled opportunistic infection (fungal, bacterial, or viral infections). Patients with history of fungal disease during induction therapy may proceed if they have a significant response to antifungal therapy with no or minimal evidence of disease remaining by CT evaluation.\n* HIV or HTLV I\u002FII infection","ALL","21 Years","EXPANDED_ACCESS","The protocol is designed to provide access to patients to the Clinimacs® CD34 TCRαβ system to prepare cells for an unlabeled indication using an HLA-compatible related or unrelated donor for allogenic transplant.",[53,54],"Transplant-Related Disorder","GVH - Graft Versus Host Reaction",[56,57],"TCR Alpha\u002FBeta","CliniMACS","2025-10-11",{"date":60,"type":61},"2025-10-14","ACTUAL",{"name":39,"class":6},1]