[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100394733":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":35,"responsibleParty":51,"collaborators":20,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":20,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":20,"enrollmentInfo":62,"targetDuration":20,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":76,"whyStopped":20,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"University of Pennsylvania","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Retreatment with CTL019\u002FCTL119","EXPERIMENTAL","All subjects will receive retreatment with CTL019\u002FCTL119 and be followed per the schedule of procedures.",[13],"Drug: CD19 redirected autologous T cells (CTL019 or CTL119 cells)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","CD19 redirected autologous T cells (CTL019 or CTL119 cells)","Retreatment with CD19-directed Chimeric Antigen Receptor-modified T Cells (CART19 cells) or huCD19-directed Chimeric Antigen Receptor-modified T Cells (huCART19 cells) in subjects with late relapse of B-cell lymphomas.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Stephen J Schuster","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Stephen J Schuster, MD","CONTACT","215.614.1846","schustes@pennmedicine.upenn.edu",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},"Emerging Medicine","855-216-0098","PennCancerTrials@careboxhealth.com",[36],{"facility":5,"status":20,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Philadelphia","Pennsylvania","19104","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-75.16362,39.95238,{"lat":46,"lon":45},[49,50],{"name":27,"role":28,"phone":33,"phoneExt":20,"email":34},{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},{"type":52,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100394733","phase-1-retreatment-with-ctl019ctl119-100394733",false,"NCT04419909","Retreatment With CTL019\u002FCTL119","Retreatment With CTL019\u002FCTL119 in Patients With Late Relapse of B-Cell Lymphomas","Inclusion Criteria:\n\n1. Diffuse Large B-Cell Lymphoma or Follicular lymphoma, previously identified as CD19+\n2. Previously treated on UPCC13413\u002F NCT02030834 with CTL019\u002FCTL119, with historical manufactured product available at Penn for reinfusion\n3. Previous complete response to CAR T-cells with a duration ≥ 6 months (defined as 168 days)\n4. No available curative treatment options (such as autologous or allogeneic HSCT) with limited prognosis (several months to \\\u003C 2 year survival) with currently available therapies.\n5. Age ≥18 years\n6. Creatinine \\\u003C 1.6 mg\u002FdL\n7. ALT\u002FAST \\\u003C 3x upper limit of normal\n8. Bilirubin \\\u003C 2.0 mg\u002FdL, unless subject has Gilbert's Syndrome (≤3.0 mg\u002FdL)\n9. Measurable or assessable disease according to the \"Revised Response Criteria for Malignant Lymphoma\" (Cheson et al., J. Clin. Onc., 2007)88. Patients in complete remission with no evidence of disease are not eligible.\n10. Performance status (ECOG) 0 or 1.\n11. Left Ventricle Ejection Fraction (LVEF) \\> 40% confirmed by ECHO\u002FMUGA\n12. Agree to contraceptive requirements outlined in Section 4.3.\n13. Provide written informed consent.\n\nExclusion Criteria:\n\n1. Uncontrolled active infection.\n2. Active hepatitis B or hepatitis C infection.\n3. Any uncontrolled active medical disorder that would preclude participation as outlined.\n4. Class III\u002FIV cardiovascular disability according to the New York Heart Association Classification (see Appendix 1).\n5. HIV infection.\n6. Patients with active CNS involvement by malignancy. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was \\>4 weeks before enrollment\n7. Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system.","ALL","18 Years",{"count":63,"type":64},12,"ESTIMATED","INTERVENTIONAL",[67],"PHASE1","This research study is designed to evaluate the effects of retreatment with CTL019\u002FCTL119 in patients with late relapse of B-cell lymphomas.",[70],"Lymphoma, B-Cell",[72,73,74,75],"CTL019","CTL119","CAR T-cell","CART","NOT_YET_RECRUITING","2025-06-27",{"date":79,"type":80},"2025-07-02","ACTUAL",{"date":82,"type":64},"2026-05",{"date":84,"type":64},"2028-07",{"name":5,"class":6},1]