[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618204":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":27,"collaborators":20,"id":29,"slug":30,"hasResults":31,"nctId":32,"briefTitle":33,"officialTitle":34,"acronym":20,"eligibilityCriteria":35,"healthyVolunteers":31,"sex":36,"minAge":37,"maxAge":38,"enrollmentInfo":39,"targetDuration":20,"studyType":42,"phases":43,"briefSummary":46,"conditions":47,"keywords":50,"overallStatus":58,"whyStopped":20,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":20},{"fullName":5,"class":6},"iCell Gene Therapeutics","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single arm","EXPERIMENTAL","Biologic drug infusion",[13],"Biological: ICG318, BCMA-CD19-IL-15\u002FIL-15 sushi Compound CAR T following cyclophosphamide-only lymphodepletion",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","ICG318, BCMA-CD19-IL-15\u002FIL-15 sushi Compound CAR T following cyclophosphamide-only lymphodepletion","Anti-BCMA, Anti-CD19 Compound CAR-T Cells",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Kevin Pinz, MS","CONTACT","6315386218","kevin.pinz@icellgene.com",{"type":28,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100618204","phase-1-bcma-cd19-ccar-t-for-the-treatment-of-refractory-lupus-100618204",false,"NCT07328581","BCMA-CD19 cCAR T for the Treatment of Refractory Lupus","Phase I, IIa, Single-Arm, Study of BCMA-CD19-IL-15\u002FIL15sushi cCAR T for the Treatment of Refractory Systemic Lupus Erythematosus, With or Without Lupus Nephritis","Key Inclusion Criteria:\n\n1. Age 16-70 years at the time of signing the informed consent\n2. Have a diagnosis of SLE by EULAR\u002FACR 2019 criteria for ≥6 months.\n3. Have at least one of an antinuclear antibody, anti-double-stranded deoxyribonucleic acid (dsDNA), or elevated anti-Smith (Sm) antibody\n4. Inadequate response to 2 prior standard of care therapies, used for at least three months\n5. SLE Disease Activity Index 2000 (SLEDAI-2K) score of ≥7 at Screening\n6. For LN cohort participants. Kidney biopsy result within 6 months prior to Screening indicating Class III or IV (alone or in combination with Class V)6.\n\nKey Exclusion Criteria:\n\n1. Any acute, severe lupus related flare that needs immediate treatment\n2. History of antiphospholipid syndrome with thromboembolic event within 12 months\n3. History or current diagnosis of any disease, condition or treatment that may confound clinical assessments in the study.\n4. Has drug-induced SLE.\n5. History of prior CAR-T therapy.\n6. History of bone marrow\u002Fhematopoietic stem cell or solid organ transplant or planned receipt during the study period.\n7. Recent serious or ongoing infection, or risk for serious infection, or acute or chronic infection\n8. Receipt of a live\u002Flive-attenuated vaccine other than BCG within 8 weeks\n9. History within the past year or current clinically significant central nervous system disease, including but not limited to cerebrovascular accident, seizures, severe brain injury, dementia, Parkinson's disease, cerebellar disease, or multiple sclerosis\n10. Impaired cardiac function or clinically significant cardiac disease\n11. End stage renal disease or severe liver disease\n12. Breastfeeding\u002Flactating or pregnant women or women who intend to become pregnant at any time during the study.","ALL","16 Years","70 Years",{"count":40,"type":41},20,"ESTIMATED","INTERVENTIONAL",[44,45],"PHASE1","PHASE2","This is a Phase I, IIa, Single-Arm, interventional, open label, treatment study to evaluate the safety and tolerability of BCMA-CD19-IL-15\u002FIL15sushi cCAR T cells in patients with relapsed and\u002For refractory SLE, with or without Lupus Nephritis.",[48,49],"Systemic Lupus Erythematosus (SLE)","Lupus Nephritis (LN)",[51,52,53,54,55,56,49,57],"Lupus","autoimmune disease","CAR-T Cell","Refractory disease","CD19","BCMA","Systemic Lupus Erythrematosus (SLE)","NOT_YET_RECRUITING","2026-01-07",{"date":61,"type":62},"2026-01-09","ACTUAL",{"date":64,"type":41},"2026-01",{"date":66,"type":41},"2028-12",{"name":5,"class":6}]