[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603357":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":45,"collaborators":19,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":19,"eligibilityCriteria":53,"healthyVolunteers":50,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":19,"studyType":60,"phases":61,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":32,"whyStopped":19,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Sheba Medical Center","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single arm, open label, dose escalation: Anti CD22 CAR-T (SHB-04-CD22)","EXPERIMENTAL","Phase 1 of this study includes a dose escalation plan of anti CD22 CAR-T (SHB-04-CD22). Treatment will start at dose level 1. According to safety assessments, dose will increase to next dose level.\n\nDose level 1: 3x10\\^5 CAR+ T cells per kilogram Dose level 2: 1x10\\^6 CAR+ T cells per kilogram Dose level 3: 3x10\\^6 CAR+ T cells per kilogram\n\nPhase 2 of this study will be a dose expansion phase of the dose recommended based on safety and expected efficacy.",[13],"Other: CD22 CAR-T cells",[15],{"type":16,"name":17,"description":17,"armGroupLabels":18,"otherNames":19},"OTHER","CD22 CAR-T cells",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Prof. Elad Jacoby, MD","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Sivan Yakobi","CONTACT","972 03 5309046","sivan.yakobi@sheba.health.gov.il",[31],{"facility":5,"status":32,"city":33,"state":34,"zip":19,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"RECRUITING","Ramat Gan","G","Israel","IL",{"type":38,"coordinates":39},"Point",[40,41],34.81065,32.08227,{"lat":41,"lon":40},[44],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},{"type":23,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Elad Jacoby, MD","Principal Investigator, Pediatric Hematology and Oncology","100603357","phase-1-a-phase-12-study-of-t-cell-expressing-an-anti-cd22-chimeric-antigen-receptor-shb-04-cd22-in-patients-with-cd22-expressing-b-cell-malignancies-100603357",false,"NCT07135466","A Phase 1\u002F2 Study of T-cell Expressing an Anti-CD22 Chimeric-Antigen Receptor (SHB-04-CD22) in Patients With CD22-expressing B-cell Malignancies","Inclusion Criteria:\n\n* Patient must have a CD22-expressing hematologic malignancy, relapsed or refractory after receiving at least 2 lines of standard therapy including CD19-directed therapy (For CD19 positive disease):\n* Relapse following standard relapse protocol (2nd relapse), including CD19 CART.\n* Primary refractory, i.e. failed to achieve morphologic remission after 2 lines of induction chemotherapy.\n* Age 1-80 years\n* CD22 expression shown by flow cytometry on at least 70% of leukemic blasts \u002F lymphoma cells\n* Adequate CD3 count (above 120 CD3+ cells per microliter blood)\n* Clinical performance status: Patients \\> 10 years of age: Karnofsky ≥ 50%; Patients ≤ 10 years of age: Lansky scale ≥ 50%. Exception for neurologic symptoms (e.g. paralysis) that are explained by the malignancy.\n* Females of child-bearing potential must have a negative pregnancy test\n* Cardiac function: LV ejection fraction \\>45% or shortening fraction \\>28%\n* At least 60 days after autologous or allogeneic BMT\n* At least 30 days after prior CAR therapy in absence of response","ALL","1 Year","80 Years",{"count":58,"type":59},50,"ESTIMATED","INTERVENTIONAL",[62,63],"PHASE1","PHASE2","This is a phase I\u002FII trial of T-cell expressing an anti-CD22 Chimeric-Antigen-Receptor (CAR) in patients with CD22 expressing B-cell malignancies. This trial is an open label, single-arm, for pediatric and adult patients with relapsed\u002Frefractory B-cell malignancies.",[66],"B Cell Malignancies",[54,68,69,70,71,72,73,74],"NHL","DLBCL","CAR-T","CD22","Chimeric Antigen Receptor","Leukemia","Lymphoma","2026-01-14",{"date":77,"type":78},"2026-01-16","ACTUAL",{"date":80,"type":59},"2026-02-01",{"date":82,"type":59},"2028-01-01",{"name":5,"class":6},1]