[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100505232":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":29,"responsibleParty":56,"collaborators":59,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":22,"eligibilityCriteria":68,"healthyVolunteers":65,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":22,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":22,"overallStatus":32,"whyStopped":22,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"RenJi Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"GC012F injection (CD19-BCMA CAR-T cells)","EXPERIMENTAL","Dose escalation phase:\n\nDL-1：0.5±20%×10\\^5\u002Fkg, DL1：1±20%×10\\^5\u002Fkg, DL2：2±20%×10\\^5\u002Fkg DL3：3±20%×10\\^5\u002Fkg",[13],"Drug: GC012F injection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","GC012F injection","Each subject will receive GC012F injection (CD19-BCMA CAR-T cells) by intravenous infusion on Day 0.",[9],[21],"CD19-BCMA CAR-T cells",null,[24],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},"Qiong Fu, PhD","CONTACT","13585603288","fuqiong5@163.com",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Department of Rheumatology, Ren Ji Hospital South Campus, School of Medicine, Shanghai JiaoTong University","RECRUITING","Shanghai","Shanghai Municipality","200001","China","CN",{"type":39,"coordinates":40},"Point",[41,42],121.45806,31.22222,{"lat":42,"lon":41},[45,48,52,54],{"name":46,"role":26,"phone":47,"phoneExt":22,"email":28},"Qiong Fu, MD","86-13585603288",{"name":49,"role":26,"phone":50,"phoneExt":22,"email":51},"Chunmei Wu, MD","86-15800605296","wuchunmei_1988@163.com",{"name":46,"role":53,"phone":22,"phoneExt":22,"email":22},"PRINCIPAL_INVESTIGATOR",{"name":55,"role":53,"phone":22,"phoneExt":22,"email":22},"Shuang Ye, MD",{"type":53,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"Qiong Fu","Professor",[60],{"name":61,"class":62},"Gracell Biotechnologies (Shanghai) Co., Ltd.","INDUSTRY","100505232","early-phase-1-dual-target-car-t-cell-treatment-for-refractory-systemic-lupus-erythematosus-sle-patients-100505232",false,"NCT05858684","Dual Target CAR-T Cell Treatment for Refractory Systemic Lupus Erythematosus (SLE) Patients","Inclusion Criteria:\n\n1. 18-70 years old;\n2. Total score ≥ 10 on the EULAR\u002FACR 2019 SLE classification criteria;\n3. LLDAS response criteria are not achieved after administration with at least two immunosuppressants (including, but not limited to, azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, leflunomide, tacrolimus, ciclosporin and iguratimod) and\u002For at least one approved biological agent for more than 6 months.\n4. SELENA-SLEDAI≥8;\n5. Patients with CD19+ B-cell;\n6. Hemoglobin≥85 g\u002FL;\n7. WBC≥2.5×10\\^9\u002FL\n8. NEUT≥1×10\\^9\u002FL;\n9. BPC≥50×10\\^9\u002FL;\n10. AST\u002FALT below 2 times the upper limit of normal; Creatinine clearance ≥30 mL\u002Fmin; blood bilirubin ≤2.0 mg\u002Fdl; echocardiography indicates that the ejection fraction is ≥50%;\n11. Adequate venous access for apheresis, and no other contraindications for leukapheresis;\n12. Women of childbearing age should have a negative serum or urine pregnancy test at screening and baseline. Subjects agree to take effective contraceptive measures during the trial until at least 1 year after CAR-T cells infusion.\n13. Agree to attend follow-up visits as required;\n14. Voluntary participation and informed consent signed by the patient or his\u002Fher legal\u002Fauthorized representative;\n\nExclusion Criteria:\n\n1. Renal disease: severe lupus nephritis (serum creatinine \\> 2.5 mg\u002FdL or 221 μmol\u002FL) within 8 weeks prior to leukapheresis, or subjects who need hemodialysis;\n2. CNS disease: including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident \\[CVA\\], encephalitis or CNS vasculitis, psychiatric patients with depression or suicidal thoughts;\n3. Patients with serious lesions and history of present illness of vital organs such as heart, liver, kidney and blood and endocrine system;\n4. Patients with immunodeficiency, uncontrolled active infections and active or recurrent peptic ulcers;\n5. Received immunosuppressive therapy within 1 week prior to leukapheresis;\n6. Patients with HIV infection; Active infection of hepatitis B virus or hepatitis C virus; Patients with syphilis infection;\n7. The presence or suspicion of an active fungal, bacterial, viral or other infection that cannot be controlled during screening;\n8. Received live vaccine treatment within 4 weeks prior to screening;\n9. Severe allergies or hypersensitivity;\n10. Contraindication to cyclophosphamide in combination with fludarabine;\n11. Subjects who have undergone major surgery within 2 weeks prior to signing the informed consent form, or who are scheduled to have surgery (other than local anesthetic surgery) during the trial or within 2 weeks of the infusion;\n12. cannula or drainage tubes other than central venous catheters;\n13. Pregnant or lactating women, or subjects who plan to have children within 1 year of treatment;\n14. Subjects with prior CD19 or BCMA-targeted therapy\n15. Participated in any clinical study within 3 months prior to enrollment\n16. Subjects with malignant tumour, except for Non-melanoma Skin Cancer with PFS\\>5yr; Cervical Cancer in situ; Bladder Cancer; Breast Cancer;\n17. Any situations that the investigator believes the patients are not suitable for the study.","ALL","18 Years","70 Years",{"count":73,"type":74},18,"ESTIMATED","INTERVENTIONAL",[77],"EARLY_PHASE1","This is an early exploratory phase, single arm, non-randomized, open label, treatment study trial to determine the maximum tolerated dose of GC012F injection (CD19-BCMA CAR-T cells) in patients with refractory systemic lupus erythematosus.",[80],"CAR-T Cell Therapy","2026-05-29",{"date":83,"type":84},"2026-06-01","ACTUAL",{"date":86,"type":84},"2023-05-11",{"date":88,"type":74},"2029-06-10",{"name":5,"class":6},1]