[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100490190":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":27,"centralContacts":32,"locations":40,"responsibleParty":67,"collaborators":69,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":21,"enrollmentInfo":83,"targetDuration":21,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":97,"whyStopped":21,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"German Cancer Research Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Donor-derived CD33-deleted CD34+ HSC combined with Gemtuzumab-Ozogamicin (GO)","EXPERIMENTAL","Patients will be transplanted with CD33-deleted CD34+ HSC derived from the initially matched family donor. Upon HSC engraftment, patients will be treated with escalating doses of the anti-CD33 antibodydrugconjugate Gemtuzumab-Ozogamicin (GO). A conditioning regimen containing GO (d-14, d-11, d-8), Fludarabine 30 mg\u002Fm2 (d-6 to d-3) and Melphalan 140mg\u002Fm2 (d-2) is used prior to transplantation.",[13,14],"Biological: Donor-derived CD34+ HSC with CRISPR\u002FCas9-mediated CD33 deletion","Drug: Gemtuzumab Ozogamicin",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"BIOLOGICAL","Donor-derived CD34+ HSC with CRISPR\u002FCas9-mediated CD33 deletion","CD33-deleted CD34+ hematopoietic stem cells derived from the initially matched family donor",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":21},"DRUG","Gemtuzumab Ozogamicin","Intrapatient intra-individual dose escalation Level 0: GO day 1 Level 1: GO day 1, day 4 Level 2: GO day 1, day 4, day 7 with repetition after 21 to 28 days up to 84 days.",[9],[28],{"name":29,"affiliation":30,"role":31},"Tim Sauer, Dr. med.","University Hospital Heidelberg","PRINCIPAL_INVESTIGATOR",[33,37],{"name":29,"role":34,"phone":35,"phoneExt":21,"email":36},"CONTACT","+49 6221 56 38010","tim.sauer@med.uni-heidelberg.de",{"name":38,"role":34,"phone":21,"phoneExt":21,"email":39},"Carsten Müller-Tidow, Prof. Dr. med.","carsten.mueller-tidow@med.uni-heidelberg.de",[41,56],{"facility":42,"status":21,"city":43,"state":21,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"University Hospital Dresden, Department of Medicine I","Dresden","01307","Germany","DE",{"type":48,"coordinates":49},"Point",[50,51],13.73832,51.05089,{"lat":51,"lon":50},[54],{"name":55,"role":34,"phone":21,"phoneExt":21,"email":21},"Martin Bornhäuser, Prof. Dr. med.",{"facility":57,"status":21,"city":58,"state":21,"zip":59,"country":45,"countryCode":46,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"University Hospital Heidelberg, Internal Medicine V","Heidelberg","69120",{"type":48,"coordinates":61},[62,63],8.69079,49.40768,{"lat":63,"lon":62},[66],{"name":29,"role":34,"phone":21,"phoneExt":21,"email":21},{"type":68,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR",[70,71],{"name":30,"class":6},{"name":72,"class":6},"University Hospital Dresden","100490190","phase-1-genetic-ablation-of-cd33-in-hsc-to-broaden-the-therapeutic-index-of-cd33-directed-immunotherapy-in-patients-with-aml-100490190",false,"NCT05662904","Genetic Ablation of CD33 in HSC to Broaden the Therapeutic Index of CD33-directed Immunotherapy in Patients with AML","Genetic Ablation of CD33 in Hematopoietic Stem Cells to Broaden the Therapeutic Index of CD33-directed Immunotherapy in Patients with Acute Myeloid Leukemia (AML)","GALAXY33","Key Inclusion Criteria:\n\n* confirmed AML according to the WHO classification\n* relapsed disease after allo-SCT from an HLA-identical family donor (≥ 2 months after allo-SCT at time of inclusion)\n* ≤ 29% of bone marrow blasts as detected by cytomorphology or immunohistochemistry\n* age ≥ 18 years\n* confirmed CD33 expression on leukemic blasts at current relapse (as detected by flow cytometry)\n* adequate organ function:\n\n  * Renal function defined as: serum creatinine of ≤ 2x ULN or eGFR ≥ 30 mL\u002Fmin\u002F1.73 m2\n  * Liver function defined as:\n\n    * ALT ≤ 3 times the ULN for the respective age\n    * Bilirubin ≤ 2.0 mg\u002Fdl with the exception of patients with hyperbilirubinemia explained by Gilbert-Meulengracht syndrome (may be included if total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN) or extrahepatic disease (e.g. chronic hemolytic anemia)\n* Minimum level of pulmonary reserve defined as ≤ grade 1 dyspnea and pulse oxygenation \\> 90% on room air\n* Hemodynamic stability and LVEF ≥ 40% as confirmed by echocardiogram\n* Absolute lymphocyte count (ALC) ≥ 100\u002Fmm3\n\nKey Exclusion Criteria:\n\n* ECOG performance status \\>2\n* Confirmed CNS involvement\n* Acute or chronic Graft versus Host disease (GvHD)\n* Availability of other curative standard treatment options\n* Prior treatment with GO\n* Prior hepatic veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS)\n* Uncontrolled active hepatitis B or C\n* HIV-positivity\n* Uncontrolled bacterial, viral or fungal infection\n* Participation in another clinical trial at the time of screening\n* Organ dysfunction (liver, kidney, lung, heart) that is a contraindication for conditioning therapy\n* Severe concomitant disease (e.g. uncontrolled arterial hypertension, heart failure NYHA III-IV, uncontrolled diabetes mellitus, uncontrolled hyperlipidemia)\n* Unstable angina and\u002For myocardial infarction within 3 months prior to screening\n* Pregnant or nursing (lactating) women","ALL","18 Years",{"count":84,"type":85},12,"ESTIMATED","INTERVENTIONAL",[88],"PHASE1","The study \"GALAXY33\" is an open-label, prospective, nonrandomized, one arm phase I clinical trial in which patients with relapsed AML after allogeneic hematopoietic stem cell transplantation will be transplanted with CD33-deleted CD34+ HSC derived from the initially matched family donor.",[91],"Relapsed\u002FRefractory Acute Myeloid Leukemia (AML)",[93,94,95,96],"AML","allogeneic stem cell transplantation","gene editing","chemotherapy resistance","NOT_YET_RECRUITING","2025-03-12",{"date":100,"type":101},"2025-03-14","ACTUAL",{"date":103,"type":85},"2028-01",{"date":105,"type":85},"2030-01",{"name":5,"class":6},2]