[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637009":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":45,"collaborators":20,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":20,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":20,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":24,"whyStopped":20,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"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],{"facility":23,"status":24,"city":25,"state":26,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"Lucille Packard Children's Hospital of Stanford University","RECRUITING","Palo Alto","California","94304","United States","US",{"type":31,"coordinates":32},"Point",[33,34],-122.14302,37.44188,{"lat":34,"lon":33},[37,42],{"name":38,"role":39,"phone":40,"phoneExt":20,"email":41},"Noor Akhter","CONTACT","650-725-9709","scgt_clinical_trials_office@lists.stanford.edu",{"name":43,"role":44,"phone":20,"phoneExt":20,"email":20},"Orly Klein, MD","PRINCIPAL_INVESTIGATOR",{"type":46,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100637009","phase-1-study-of-quail-100-in-pediatric-and-young-adult-participants-with-high-risk-hematologic-malignancies-who-have-received-a-hematopoietic-stem-cell-transplantation-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":58,"type":59},12,"ESTIMATED","INTERVENTIONAL",[62],"PHASE1","Study of QUAIL-100 in Patients With High Risk Acute Leukemia and Myelodysplastic Syndrome Who Have Received Hematopoietic Stem Cell Transplant",[65,66],"Acute Leukemia","Myelodysplastic Syndrome",[68,69,70,71,72,73,74],"Leukemia","Myelodysplastic Syndrome (MDS)","Acute Lymphocytic Leukemia (ALL)","Acute Myeloid Leukemia (AML)","transplant","hematopoietic stem cell transplant","LGNA-100","2026-08-19",{"date":77,"type":78},"2026-08-21","ACTUAL",{"date":80,"type":59},"2026-08",{"date":82,"type":59},"2029-03",{"name":5,"class":6},1]