[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598887":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":25,"responsibleParty":49,"collaborators":11,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":11,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":77,"whyStopped":11,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Chinese PLA General Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"This is a single arm treatment of CAR19BCMA CAR-T cell","EXPERIMENTAL",null,[13],"Other: CAR19BCMA-T cells",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":11},"CAR19BCMA-T cells","CAR19BCMA-T cells Each subject will be infused with single dose of CD19BCMA-CAR-T cells. A classic \"3+3\" dose escalation will be employed. The low dose is 1×10\\^6 \u002Fkg, the medium dose is 2×10\\^6 \u002Fkg, and the high dose is 3×10\\^6 \u002Fkg.\n\nDrug: fludarabine and cyclophosphamide Drug: Fludarabine Fludarabine will be given at a dose of 30 mg\u002Fm2\u002Fday intravenously (IV) for 3 days prior to the infusion of CD19BCMA-CAR-T cells. Drug: Cyclophosphamide Cyclophosphamide will be given at a dose of 300 mg",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},"Yi Liu Dr","CONTACT","+86 186 0031 0985","18600310985@163.com",[26,42],{"facility":27,"status":11,"city":28,"state":11,"zip":11,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":37},"The Four Medical Center of PLA General Hospital, China","Beijing","China","CN",{"type":32,"coordinates":33},"Point",[34,35],116.39723,39.9075,{"lat":35,"lon":34},[38],{"name":39,"role":22,"phone":40,"phoneExt":11,"email":41},"XiaoHong Li Dr","+86 136 9366 6349","lily.lxh@163.com",{"facility":43,"status":11,"city":28,"state":11,"zip":11,"country":29,"countryCode":30,"cosmosGeoPoint":44,"geoPoint":46,"contacts":47},"The Six Medical Center of PLA General Hospital, China",{"type":32,"coordinates":45},[34,35],{"lat":35,"lon":34},[48],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Chunji Gao","Principal Investigator","100598887","early-phase-1-car19bcma-car-t-cells-for-the-treatment-of-rr-plasma-cell-neoplasms-100598887",false,"NCT07077330","CAR19BCMA CAR-T Cells for the Treatment of R\u002FR Plasma Cell Neoplasms","A Clinical Study on the Safety and Efficacy of CAR19-BCMA Dual-target CAR-T Cell Therapy for Relapsed\u002FRefractory Plasma Cell Neoplasms","CAR19BCMA","Inclusion Criteria:\n\n1. Relapsed\u002Frefractory CD19BCMA positive plasma cell neoplasms must be assured and meet all of the following conditions:\n\n   1.1 Confirmation for either BCMA or CD19 positivity using immunohistochemistry or flow cytometry.\n\n   1.2 Patients with multiple myeloma, plasma cell carcinoma, and plasma cell leukemia who have received at least three 3 lines treatment (including anti-CD38 monoclonal antibodies, protease inhibitors, immunosuppressants, etc.) but have failed or experienced relapse.\n\n   1.3 Patients with system light chain amyloidosis who have received at least 2 lines treatments in the past \\[anti-CD38 monoclonal antibody, proteasome inhibitor (PI), or immunomodulatory drug (IMiD)\\], but have failed or experienced relapse.\n2. Age 18-75 years,\n3. no gender restrictions;\n4. ECOG score ≤ 2 points;\n5. Expected survival period is not less than 3 months;\n6. HGB≥60g\u002FL;\n7. Liver and kidney function and cardiopulmonary function meet the following requirements: (1) Creatinine ≤ 2× ULN; (2)left ventricular ejection fraction≥50%; (3) Oxygen saturation \\>90%; (4)Total bilirubin ≤1.5×ULN, ALT and AST≤2.5×ULN;\n8. Participants agreed to use contraception from the time of informed consent until 1 year after CAR-T cell infusion.\n\nExclusion Criteria:\n\n1. Severe heart failure with left ventricular ejection fraction \\\u003C50%;\n2. A history of severe lung function impairment; Combined with other advanced malignant tumors;\n3. Complicated with severe infection that could not be effectively controlled;\n4. Severe autoimmune disease or congenital immune deficiency;\n5. Active viral hepatitis (defined as positive hepatitis B virus DNA \\[HBV-DNA\\] or hepatitis C virus RNA \\[HCV-RNA\\] detection, with test results exceeding the lower limit of quantification); Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection;\n6. History of severe allergy to biological products (including antibiotics);\n7. Allogeneic hematopoietic stem cell transplant patients who still have an acute graft-versus-host response (GVHD) one month after discontinuation of immunosuppressants;\n8. Patients with other serious physical or mental illnesses or laboratory abnormalities that could increase the risk of participating in the study or interfere with the results of the study, and those who were deemed by the investigator to be unsuitable for participation in the study;\n9. Female patients (those with fertility) are in pregnancy or lactation.","ALL","18 Years","75 Years",{"count":65,"type":66},20,"ESTIMATED","INTERVENTIONAL",[69],"EARLY_PHASE1","This is a single arm study to evaluate the safety and efficacy of CAR19BCMA CAR-T cells in the treatment of relapsed\u002Frefractory CD19\u002FBCMA positive plasma cell neoplasms.",[72],"Relapsed or Refractory Plasma Cell Neoplasms",[74,75,76],"CAR-T","plasma cell neoplasms","CD19\u002FBCMA","NOT_YET_RECRUITING","2025-07-21",{"date":80,"type":81},"2025-07-22","ACTUAL",{"date":83,"type":66},"2025-08-01",{"date":85,"type":66},"2027-08-01",{"name":5,"class":6},2]