[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642308":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":42,"collaborators":20,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":20,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":20,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":20,"overallStatus":29,"whyStopped":20,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},{"fullName":5,"class":6},"The First Affiliated Hospital of Soochow University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Allogeneic CAR-T cell therapy","EXPERIMENTAL","Newly Diagnosed Multiple Myeloma Patients are treated with allogeneic CAR-T cell therapy",[13],"Drug: BCMA\u002FCD19-targeted allogeneic CAR-T",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","BCMA\u002FCD19-targeted allogeneic CAR-T","Lymphodepletion chemotherapy followed by allogeneic CAR-T cell (RN1201) infusion",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Xiaowen Tang","CONTACT","13913538266","tangxiaowen@suda.edu.cn",[28],{"facility":5,"status":29,"city":30,"state":31,"zip":20,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"RECRUITING","Suzhou","Jiangsu","China","CN",{"type":35,"coordinates":36},"Point",[37,38],120.59538,31.30408,{"lat":38,"lon":37},[41],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"type":43,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100642308","phase-1-safety-and-efficacy-of-rn1201-injection-as-first-line-treatment-for-newly-diagnosed-multiple-myeloma-100642308",false,"NCT07652138","Safety and Efficacy of RN1201 Injection as First-Line Treatment for Newly Diagnosed Multiple Myeloma","An Exploratory Clinical Study on the Safety and Efficacy of RN1201 Injection as First-Line Treatment for Newly Diagnosed Multiple Myeloma","Inclusion Criteria:\n\n1. Willingness to participate in the trial and provide written informed consent.\n\n   * 2\\. Diagnosis of multiple myeloma (MM) per the 2017 revised WHO criteria.\n   * 3\\. BCMA-positive multiple myeloma documented at screening or in prior medical records.\n   * 4\\. Aged 18 - 70 years, any gender.\n   * 5\\. Life expectancy of at least 12 weeks.\n   * 6\\. Serum total bilirubin \\\u003C twice the upper limit of normal (ULN); serum creatinine within normal range;\n   * 7\\. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C three times ULN.\n   * 8\\. ECOG performance status score of 0 - 2.\n   * 9\\. Left ventricular ejection fraction (LVEF) ≥50% with no pericardial effusion.\n   * 10\\. Ability to adhere to the study visit schedule and protocol requirements.\n\nExclusion Criteria:\n\n1. Patients with serious active infections.\n\n   * 2\\. Subjects with acquired or congenital immunodeficiency.\n   * 3\\. Subjects with Class III\u002FIV heart failure per NYHA criteria.\n   * 4\\. Subjects with epilepsy or other central nervous system diseases.\n   * 5\\. Subjects with a history of primary cancer, except:\n\n     1. Resected non-melanoma (e.g., basal cell carcinoma)\n     2. Cured carcinoma in situ (e.g., cervical, bladder, breast cancer)\n   * 6\\. Systemic high-dose steroid use within 2 weeks before treatment.\n   * 7\\. Pregnant, breastfeeding women, or those planning pregnancy in 6 months.\n   * 8\\. Participation in other clinical trials within one month.\n   * 9\\. Major surgery within 14 days before the first study drug dose.\n   * 10\\. Any condition the investigator deems may raise subject risks or affect trial results.","ALL","18 Years","70 Years",{"count":55,"type":56},18,"ESTIMATED","INTERVENTIONAL",[59],"PHASE1","This is a single-arm, dose-escalation exploratory study evaluating the safety and efficacy of RN1201, a BCMA\u002FCD19-targeted allogeneic CAR-T cell therapy, in patients with newly diagnosed multiple myeloma. Patients will receive lymphodepletion followed by a single infusion of RN1201. Primary endpoints include incidence and severity of treatment-emergent adverse events. Secondary endpoints assess response rate and minimal residual disease (MRD) status.",[62,63],"Multiple Myloma","Newly Diagnosed Multiple Myeloma (NDMM)","2026-06-11",{"date":66,"type":67},"2026-06-16","ACTUAL",{"date":69,"type":67},"2025-07-30",{"date":71,"type":56},"2027-11-30",{"name":5,"class":6},1]