[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591739":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":45,"centralContacts":49,"locations":57,"responsibleParty":81,"collaborators":31,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":31,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":31,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":105,"whyStopped":31,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Genentech, Inc.","INDUSTRY",[8,17,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation","EXPERIMENTAL","Participants with SLE (with or without LN) will receive the following interventions and dose escalated per protocol:\n\nBiological: P-CD19CD20-ALLO1 Drug: Cyclophosphamide Drug: Fludarabine Drug: Rimiducid",[13,14,15,16],"Biological: P-CD19CD20-ALLO1 Cells","Drug: Cyclophosphamide","Drug: Fludarabine","Drug: Rimiducid",{"label":18,"type":10,"description":19,"interventionNames":20},"Dose Expansion (LN cohort)","Participants with SLE (with LN) will receive the following interventions at or below the maximum tolerated dose (MTD), as determined in the dose escalation stage per protocol:\n\nBiological: P-CD19CD20-ALLO1 Drug: Cyclophosphamide Drug: Fludarabine Drug: Rimiducid",[13,14,15,16],{"label":22,"type":10,"description":23,"interventionNames":24},"Dose Expansion (ERL cohort)","Participants with SLE (with ERL) will receive the following interventions at or below the maximum tolerated dose (MTD), as determined in the dose escalation stage per protocol:\n\nBiological: P-CD19CD20-ALLO1 Drug: Cyclophosphamide Drug: Fludarabine Drug: Rimiducid",[13,14,16],[26,32,37,41],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"BIOLOGICAL","P-CD19CD20-ALLO1 Cells","P-CD19CD20-ALLO1 cells will be administered intravenously as per the schedule specified in the protocol.",[9,22,18],null,{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":31},"DRUG","Cyclophosphamide","Cyclophosphamide will be administered intravenously.",[9,22,18],{"type":33,"name":38,"description":39,"armGroupLabels":40,"otherNames":31},"Fludarabine","Fludarabine will be administered intravenously.",[9,18],{"type":33,"name":42,"description":43,"armGroupLabels":44,"otherNames":31},"Rimiducid","Rimiducid will be used as a rescue therapy in the event of the occurrence of severe or life-threatening adverse events. It will be administered intravenously.",[9,22,18],[46],{"name":47,"affiliation":5,"role":48},"Clinical Trials","STUDY_DIRECTOR",[50,55],{"name":51,"role":52,"phone":53,"phoneExt":31,"email":54},"Reference Study ID Number: GA45767 https:\u002F\u002Fforpatients.roche.com\u002F","CONTACT","888-662-6728 (U.S.)","global-roche-genentech-trials@gene.com",{"name":56,"role":52,"phone":31,"phoneExt":31,"email":31},"Fastest response: use the inquiry form. No email attachments https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",[58,71],{"facility":59,"status":31,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":31},"University of Alabama at Birmingham: The Kirklin Clinic","Birmingham","Alabama","35233","United States","US",{"type":66,"coordinates":67},"Point",[68,69],-86.80249,33.52066,{"lat":69,"lon":68},{"facility":72,"status":31,"city":73,"state":74,"zip":75,"country":63,"countryCode":64,"cosmosGeoPoint":76,"geoPoint":80,"contacts":31},"University of Iowa","Iowa City","Iowa","52242",{"type":66,"coordinates":77},[78,79],-91.53017,41.66113,{"lat":79,"lon":78},{"type":82,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100591739","phase-1-a-study-to-evaluate-the-safety-tolerability-cellular-kinetics-pharmacodynamics-and-efficacy-of-p-cd19cd20-allo1-in-participants-with-severe-treatment-refractory-systemic-lupus-erythematosus-sle-100591739",false,"NCT06984341","A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in Participants With Severe, Treatment-refractory Systemic Lupus Erythematosus (SLE)","A Phase I, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in Patients With Severe, Treatment-refractory Systemic Lupus Erythematosus","Key Inclusion criteria:\n\n18-75 years old\n\nSLE diagnosis per 2019 EULAR\u002FACR classification criteria ≥ 24 weeks\n\nAutoantibody positive and low complement at screening\n\nTreatment refractory: Failed ≥ 2 treatments for at least 3 months\n\nHighly active disease:\n\nSLEDAI-2K ≥ 8 (excluding alopecia, headache, and fever; additional protocol-specified requirements to enhance specificity of findings)\n\nBILAG-2004 cat A in ≥ 1 organ system and\u002For cat B in ≥ 2 organ systems (excluding constitutional, musculoskeletal, and\u002For mucocutaneous organ systems for category B)\n\nPGA score ≥ 1.0 on a 0 to 3 VAS\n\nFor patients with lupus nephritis:\n\nBiopsy-proven Class III or IV (± Class V) active LN per 2018 ISN\u002FRPS criteria within 12 months of screening\n\nModified NIH activity index ≥ 1\u002F24\n\nUPCR ≥ 1g\u002Fg\n\nKey Exclusion criteria:\n\nParticipants who are pregnant, breastfeeding, or intend to become pregnant within the timeframe in which contraception is required\n\nPrior treatment with CAR T-cell therapy, B-cell-targeting T-cell-dependent bispecific antibody, gene therapy product, total body irradiation, allograft organ transplant, or hematopoietic stem cell transplant\n\nSignificant organ impairment (renal, hepatic, cardiac, or pulmonary) or uncontrolled medical disease which, in the investigator's opinion would preclude patient participation or that may require treatment with systemic corticosteroids or immunosuppressants during the study\n\nActive severe or unstable neuropsychiatric disease\n\nProtocol-specified active or chronic infections, recent major episode of infection\n\nHigh-risk medical conditions (e.g. high bleeding risk, history of cancer, recent major surgery, history of HLH\u002FMAS, substance abuse within the previous year)\n\nOther protocol-defined inclusion\u002Fexclusion criteria apply","ALL","18 Years","75 Years",{"count":94,"type":95},162,"ESTIMATED","INTERVENTIONAL",[98],"PHASE1","The purpose of this study is to evaluate the safety and tolerability of P-CD19CD20-ALLO1 in participants with highly active, severe, refractory SLE with or without lupus nephritis (LN). This study includes a dose-escalation stage followed by an expansion stage. It will also evaluate the cellular kinetics (CK), pharmacodynamics (PD), and efficacy of P-CD19CD20-ALLO1.",[101],"Systemic Lupus Erythematosus",[103,104],"Lupus Nephritis","CAR-T therapy","NOT_YET_RECRUITING","2026-06-19",{"date":108,"type":109},"2026-06-24","ACTUAL",{"date":111,"type":95},"2026-06-30",{"date":113,"type":95},"2033-11-01",{"name":5,"class":6},2]