[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637009":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":41,"collaborators":20,"id":43,"slug":20,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":20,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":20,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":70,"whyStopped":20,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Laguna Biotherapeutics, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"QUAIL-100 SIngle Ascending Dose","EXPERIMENTAL","Single doses of QUAIL-100 at 3x10\\^7 to 1x10\\^9 CFU",[13],"Biological: QUAIL-100",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","QUAIL-100","live, attenuated bacterial therapeutic",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Russell Carrington, PhD","CONTACT","888-498-6065","clinical@lagunabio.com",[28],{"facility":29,"status":20,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":20},"Lucille Packard Children's Hospital of Stanford University","Palo Alto","California","94304","United States","US",{"type":36,"coordinates":37},"Point",[38,39],-122.14302,37.44188,{"lat":39,"lon":38},{"type":42,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100637009",false,"NCT07573111","Study of QUAIL-100 in Pediatric and Young Adult Participants With High-Risk Hematologic Malignancies Who Have Received a Hematopoietic Stem Cell Transplantation","An Open-label, First-in-Human, Single Ascending Dose Study of QUAIL-100 in Pediatric and Young Adult Subjects With High-Risk Acute Leukemias and Myelodysplastic Syndrome Who Have Received a T-cell Receptor (TCR) αβ+ T Cell\u002FCD-19+ B Cell-Depleted Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* Weight \\>\u002F= 10 kg\n* Have received HLA-partially matched related or unrelated donor ab-depleted hematopoietic stem cell transplant (HSCT) for high-risk malignant disease and has achieved myeloid and platelet engraftment\n* Lanksy\u002FKarnofsky score \\> 60\n* Participants of childbearing potential must agree to use contraception to prevent pregnancy\n\nExclusion Criteria:\n\n* Active Grade II acute graft versus host disease (aGVHD) requiring \\> 0.5 mg\u002Fkg methylprednisolone or any diagnosis of Grade III\u002FIV aGVHD\n* Significant cardiac, pulmonary, renal, hepatic, GI, neurological or immunological disease that could compromise safe participation\n* Known allergies, hypersensitivity or intolerance to both amoxicillin and gentamycin\n* Implanted medical devices with high potential for bacterial seeding, including pacemakers, artificial cardiac valves, prosthetic joints, orthopedic plates or screws, atrial appendage or inferior vena cava devices for thrombosis prevention\n* Planned anti-leukemic therapy within 21 days of planned dosing\n* Use of tumor necrosis factor (TNF) a or phosphatidylinositol 3-kinase (PI3K) inhibitors within 60 days of screening\n* Any prior investigational Listeria product including QUAIL-100\n* Live, attenuated vaccine within 4 weeks of first dose","ALL","18 Months","39 Years",{"count":53,"type":54},12,"ESTIMATED","INTERVENTIONAL",[57],"PHASE1","Study of QUAIL-100 in Patients With High Risk Acute Leukemia and Myelodysplastic Syndrome Who Have Received Hematopoietic Stem Cell Transplant",[60,61],"Acute Leukemia","Myelodysplastic Syndrome",[63,64,65,66,67,68,69],"Leukemia","Myelodysplastic Syndrome (MDS)","Acute Lymphocytic Leukemia (ALL)","Acute Myeloid Leukemia (AML)","transplant","hematopoietic stem cell transplant","LGNA-100","NOT_YET_RECRUITING","2026-05-08",{"date":73,"type":74},"2026-05-13","ACTUAL",{"date":76,"type":54},"2026-06",{"date":78,"type":54},"2029-03",{"name":5,"class":6},1]