protocolSection identificationModule nctId: NCT06340490, orgStudyIdInfo id: RJMty19-AID002, briefTitle: A Study of RJMty19 in Refractory Systemic Lupus Erythematosus (SLE), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Guangdong Ruishun Biotech Co., Ltd, class: INDUSTRY, collaborators name: RenJi Hospital, collaborators name: Peking University People's Hospital, collaborators name: Changhai Hospital, collaborators name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, descriptionModule briefSummary: This study is an open-label, single-arm, dose escalation and dose expansion study to evaluate the safety, maximum tolerated dose, pharmacokinetic characteristics of allogeneic CD19-CAR-DNT cells (RJMty19) after infusion, and preliminary efficacy in systemic lupus erythematosus (SLE) subjects., conditionsModule conditions: Systemic Lupus Erythematosus, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: RJMty19 (CD19-CAR-DNT cells), outcomesModule primaryOutcomes measure: Dose-Limiting Toxicity (DLT), primaryOutcomes measure: Maximum Tolerated Dose (MTD), primaryOutcomes measure: Incidence of abnormalities, secondaryOutcomes measure: Pharmacokinetics (PK) indicator (Cmax), secondaryOutcomes measure: Pharmacokinetics (PK) indicator (AUC), secondaryOutcomes measure: Pharmacokinetics (PK) indicator (CAR copy numbers), secondaryOutcomes measure: Remission rate of SLE based on DORIS criteria, secondaryOutcomes measure: Remission rate of SLE based on LLDAS criteria, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University People's Hospital, city: Beijing, state: Beijing, zip: 100044, country: China, contacts name: Zhanguo Li, MD, PHD, role: CONTACT, phone: +086-13910713924, email: li99@bjmu.edu.cn, contacts name: Chun Li, MD, PHD, role: CONTACT, phone: +086-13811190098, email: 13811190098@163.com, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Nanjing Drum Tower Hospital, city: Nanjing, state: Jiangsu, zip: 210008, country: China, contacts name: Lingyun Sun, MD, PhD, role: CONTACT, phone: +086-025-83105555, email: lingyunsun2012@163.com, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, city: Shanghai, state: Shanghai, zip: 200001, country: China, contacts name: Shuang Ye, MD, PHD, role: CONTACT, phone: +086-13817615871, email: ye_shuang2000@163.com, contacts name: Qiong Fu, MD, PHD, role: CONTACT, phone: +086-13585603288, email: fuqiong@renji.com, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Changhai Hospital, city: Shanghai, state: Shanghai, zip: 200433, country: China, contacts name: Dongbao Zhao, MD, PhD, role: CONTACT, phone: +86-15921061314, email: dongbaozhao@163.com, contacts name: Jie Gao, MD, PhD, role: CONTACT, phone: +086-13585561861, email: gaojif@tom.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False