[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100347357":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":41,"centralContacts":45,"locations":53,"responsibleParty":201,"collaborators":40,"id":203,"slug":40,"hasResults":204,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":40,"eligibilityCriteria":208,"healthyVolunteers":204,"sex":209,"minAge":210,"maxAge":211,"enrollmentInfo":212,"targetDuration":40,"studyType":215,"phases":216,"briefSummary":218,"conditions":219,"keywords":40,"overallStatus":56,"whyStopped":40,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":233},{"fullName":5,"class":6},"Orca Biosystems, Inc.","INDUSTRY",[8,14,18,22,26,30],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A","EXPERIMENTAL","Recipients with human leukocyte antigen (HLA)-identical related or unrelated or 1-allele mismatched (7\u002F8 alleles) unrelated donor undergoing myeloablative conditioning (MAC); with single- or dual-agent graft-versus-host disease (GVHD) prophylaxis given",[13],"Biological: OrcaGraft (Orca-Q)",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm B","Recipients with haploidentical-related donors undergoing MAC; with single- or dual-agent GVHD prophylaxis given",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Arm C","Recipients with an HLA-identical related or unrelated donor undergoing MAC; no GVHD prophylaxis given",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Arm D","Recipients with an HLA-identical related or unrelated donor undergoing non-myeloablative (NMA)\u002Freduced intensity conditioning (RIC); with dual agent GVHD prophylaxis given",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Arm E","Recipients with 1-allele mismatched (7\u002F8 alleles) unrelated donor undergoing NMA\u002FRIC; with dual-agent GVHD 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States","US",{"type":63,"coordinates":64},"Point",[65,66],-117.97729,34.13945,{"lat":66,"lon":65},[69],{"name":70,"role":48,"phone":40,"phoneExt":40,"email":40},"Amandeep Salhotra, MD",{"facility":72,"status":56,"city":73,"state":58,"zip":74,"country":60,"countryCode":61,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"UC Davis","Sacramento","95817",{"type":63,"coordinates":76},[77,78],-121.4944,38.58157,{"lat":78,"lon":77},[81],{"name":82,"role":48,"phone":40,"phoneExt":40,"email":40},"Mehrdad Abedi, MD",{"facility":84,"status":56,"city":85,"state":58,"zip":86,"country":60,"countryCode":61,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Stanford Health Care","Stanford","94305",{"type":63,"coordinates":88},[89,90],-122.16608,37.42411,{"lat":90,"lon":89},[93],{"name":94,"role":48,"phone":40,"phoneExt":40,"email":40},"Robert Lowsky, MD",{"facility":96,"status":56,"city":97,"state":98,"zip":99,"country":60,"countryCode":61,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Moffitt Cancer Center","Tampa","Florida","33612",{"type":63,"coordinates":101},[102,103],-82.45843,27.94752,{"lat":103,"lon":102},[106],{"name":107,"role":48,"phone":40,"phoneExt":40,"email":40},"Rawan Faramand, MD",{"facility":109,"status":110,"city":111,"state":112,"zip":113,"country":60,"countryCode":61,"cosmosGeoPoint":114,"geoPoint":118,"contacts":40},"Emory University","ACTIVE_NOT_RECRUITING","Atlanta","Georgia","30322",{"type":63,"coordinates":115},[116,117],-84.38798,33.749,{"lat":117,"lon":116},{"facility":120,"status":121,"city":122,"state":123,"zip":124,"country":60,"countryCode":61,"cosmosGeoPoint":125,"geoPoint":129,"contacts":40},"The University of Kansas Hospital","WITHDRAWN","Kansas City","Kansas","66160",{"type":63,"coordinates":126},[127,128],-94.62746,39.11417,{"lat":128,"lon":127},{"facility":131,"status":56,"city":132,"state":133,"zip":134,"country":60,"countryCode":61,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"John Theurer Cancer Center at Hackensack University Medical Center","Hackensack","New Jersey","07601",{"type":63,"coordinates":136},[137,138],-74.04347,40.88593,{"lat":138,"lon":137},[141],{"name":142,"role":48,"phone":40,"phoneExt":40,"email":40},"Siddhartha Reddy, MD",{"facility":144,"status":56,"city":145,"state":145,"zip":146,"country":60,"countryCode":61,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Memorial Sloan Kettering Cancer Center","New York","10065",{"type":63,"coordinates":148},[149,150],-74.00597,40.71427,{"lat":150,"lon":149},[153],{"name":154,"role":48,"phone":40,"phoneExt":40,"email":40},"Roni Tamari, MD",{"facility":156,"status":110,"city":157,"state":158,"zip":159,"country":60,"countryCode":61,"cosmosGeoPoint":160,"geoPoint":164,"contacts":40},"Ohio State University","Columbus","Ohio","43210",{"type":63,"coordinates":161},[162,163],-82.99879,39.96118,{"lat":163,"lon":162},{"facility":166,"status":56,"city":167,"state":168,"zip":169,"country":60,"countryCode":61,"cosmosGeoPoint":170,"geoPoint":174,"contacts":175},"University of Texas MD Anderson Cancer Center","Houston","Texas","77054",{"type":63,"coordinates":171},[172,173],-95.36327,29.76328,{"lat":173,"lon":172},[176],{"name":177,"role":48,"phone":40,"phoneExt":40,"email":40},"Samer Srour, MD",{"facility":179,"status":56,"city":180,"state":181,"zip":182,"country":60,"countryCode":61,"cosmosGeoPoint":183,"geoPoint":187,"contacts":188},"Fred Hutchinson Cancer Center","Seattle","Washington","98109",{"type":63,"coordinates":184},[185,186],-122.33207,47.60621,{"lat":186,"lon":185},[189],{"name":190,"role":48,"phone":40,"phoneExt":40,"email":40},"Boglarka Gyurkocza, MD",{"facility":192,"status":121,"city":193,"state":194,"zip":195,"country":60,"countryCode":61,"cosmosGeoPoint":196,"geoPoint":200,"contacts":40},"Froedtert Memorial Lutheran Hospital","Milwaukee","Wisconsin","53226",{"type":63,"coordinates":197},[198,199],-87.90647,43.0389,{"lat":199,"lon":198},{"type":202,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100347357",false,"NCT03802695","A Phase 1 Study of Orca-Q in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies","A Phase 1 Dose Escalation and Expansion Study of Orca-Q, an Engineered Donor Graft Derived From Mobilized Peripheral Blood, in Recipients Undergoing Allogeneic Hematopoietic Cell Transplantation for Hematologic Malignancies","Key Inclusion Criteria:\n\n1. Age at the time of enrollment:\n\n   1. For MAC with fully matched donor (Arm A with 8\u002F8 donor and Arm C) and NMA\u002FRIC: Age ≥ 12 and ≤ 78 years\n   2. For MAC with mismatched donors (Arm A with 7\u002F8 donor and Arm B): Age ≥ 12 and ≤ 65 years\n2. Diagnosed acute myeloid, lymphoblastic or mixed phenotype leukemia, or high or very high risk myelodysplastic syndrome (MDS) either in complete remission (CR) or with ≤ 10 percent of blast cells in bone marrow (BM)\n3. Indicated for allogeneic hematopoietic stem cell transplant (alloHCT)\n4. Matched to a 8\u002F8 or 7\u002F8 related or unrelated donor, or to a related haploidentical donor\n5. Estimated glomerular filtration rate (eGFR) \\> 50 mL\u002Fminute (MAC with tacrolimus) or \\> 30 mL\u002Fminute (NMA\u002FRIC or MAC without tacrolimus)\n6. Cardiac parameters: Cardiac ejection fraction ≥ 45 percent (MAC) or ≥ 40 percent (NMA\u002FRIC)\n7. Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50 percent for MAC or ≥ 40 percent for NMA\u002FRIC\n8. Liver function: Total bilirubin \\\u003C 1.5 times upper limit of normal (ULN) (MAC) or \\\u003C 3 times ULN (NMA\u002FRIC); alanine transaminase (ALT)\u002Faspartate transaminase (AST) \\\u003C 3 times ULN (MAC) or \\\u003C 5 times ULN (NMA\u002FRIC)\n9. Participants enrolling on NMA\u002FRIC-alloHCT arms must be deemed unfit for a myeloablative alloHCT per assessment of the principal investigator (PI)\n\nKey Exclusion Criteria:\n\n1. Prior alloHCT\n2. Currently receiving corticosteroids or other immunosuppressive therapy except for approved disease-specific therapy for the patient's underlying hematologic malignancy. Topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg\u002Fday are allowed\n3. Planned donor lymphocyte infusion (DLI)\n4. Planned pharmaceutical in vivo or ex vivo T cell depletion, e.g., post-transplant cyclophosphamide (Cy) or alemtuzumab\n5. Positive anti-donor HLA antibodies against a mismatched allele in the selected donor\n6. Low performance score: For MAC: Karnofsky Performance Score (KPS) \\\u003C 70 percent, For NMA\u002FRIC: \\\u003C60 percent\n7. High HCT-specific Comorbidity Index (HCT-CI): For MAC \\> 4, For NMA\u002FRIC \\>6\n8. Uncontrolled bacterial, viral or fungal infections (currently taking antimicrobial therapy and with progression or no clinical improvement) at time of enrollment\n9. Seropositive for human immunodeficiency virus (HIV)-1 or -2, human T-lymphotropic virus (HTLV)-1 or -2 or Hepatitis B surface antigen (HbsAg) or anti-Hepatitis C virus (HCV) antibody (Ab)\n10. Any uncontrolled autoimmune disease requiring active immunosuppressive treatment\n11. Concurrent malignancies or active disease within 1 year, except non-melanoma skin cancers that have been curatively resected. Patients with concurrent indolent hematologic malignancies that do not require active treatment and are under active surveillance only (such as CLL, low-grade lymphomas, smoldering MM, MZL) may be included with the approval of Medical Monitor\n12. History of idiopathic or secondary myelofibrosis\n13. Women who are pregnant or breastfeeding","ALL","12 Years","78 Years",{"count":213,"type":214},300,"ESTIMATED","INTERVENTIONAL",[217],"PHASE1","This study will evaluate the safety, tolerability, and efficacy of engineered donor grafts (\"OrcaGraft\"\u002F\"Orca-Q\") in participants undergoing allogeneic hematopoietic cell transplant (alloHCT) transplantation for hematologic malignancies.",[220,221,222,223],"Acute Myeloid Leukemia","Myelodysplastic Syndromes","Mixed Phenotype Acute Leukemia","Acute Lymphoblastic Leukemia","2026-06-29",{"date":226,"type":227},"2026-07-01","ACTUAL",{"date":229,"type":227},"2019-04-08",{"date":231,"type":214},"2027-12",{"name":5,"class":6},12]