[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lymphomasleukemias-with-plasmacytic-differentiation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lymphomasleukemias-with-plasmacytic-differentiation":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100591900","early-phase-1-car19bcma-car-t-cells-for-the-treatment-of-rr-plasma-cell-neoplasms-and-lymphomasleukemias-with-plasmacytic-differentiation-100591900",false,"NCT06986434","CAR19BCMA CAR-T Cells for the Treatment of R\u002FR Plasma Cell Neoplasms and Lymphomas\u002FLeukemias With Plasmacytic Differentiation","A Clinical Study on the Safety and Efficacy of CAR19-BCMA Dual-target CAR-T Cell Therapy for Relapsed\u002FRefractory Plasma Cell Neoplasms and Lymphomas\u002FLeukemias With Plasmacytic Differentiation","Inclusion Criteria:\n\n1. Relapsed\u002Frefractory CD19BCMA positive plasma cell neoplasms and lymphomas\u002Fleukemias with plasmacytic differentiation must be assured and meet all of the following conditions:\n\n   * Confirmation for either BCMA or CD19 positivity using immunohistochemistry or flow cytometry\n   * Patients with multiple myeloma, plasma cell carcinoma, plasma cell leukemia and lymphomas\u002Fleukemias with plasmacytic differentiation 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   * 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 18-80 years, no gender restrictions\n3. ECOG score ≤ 2 points\n4. Expected survival period is not less than 3 months\n5. HGB≥60g\u002FL\n6. Liver function and cardiopulmonary function meet the following requirements:\n\n   * left ventricular ejection fraction≥50%\n   * Oxygen saturation \\>90%\n   * Total bilirubin ≤1.5×ULN, ALT and AST≤2.5×ULN\n7. Participants agreed to use contraception from the time of informed consent until 1 year after CAR-T cell infusion\n\nExclusion Criteria:\n\n* Severe heart failure with left ventricular ejection fraction \\\u003C50%\n* A history of severe lung function impairment\n* Combined with other advanced malignant tumors\n* Complicated with severe infection that could not be effectively controlled\n* Severe autoimmune disease or congenital immune deficiency\n* Active hepatitis (hepatitis B virus DNA \\[HBV-DNA\\] or hepatitis C virus RNA \\[HCV-RNA\\] test results above the lower limit of detection)\n* Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection\n* History of severe allergy to biological products (including antibiotics)\n* 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\n* Female patients (those with fertility) are in pregnancy or lactation","ALL","18 Years","75 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"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 and lymphomas\u002Fleukemias with plasmacytic differentiation.",[27,28],"Relapsed or Refractory Plasma Cell Neoplasms","Lymphomas\u002FLeukemias With Plasmacytic Differentiation",[30,31,32,33],"CAR-T","plasma cell neoplasms","CD19\u002FBCMA","lymphomas\u002Fleukemias with plasmacytic differentiation","NOT_YET_RECRUITING","2026-04-07",{"date":37,"type":38},"2026-04-08","ACTUAL",{"date":40,"type":21},"2026-04-02",{"date":42,"type":21},"2028-08-25",{"name":44,"class":45},"Affiliated Hospital to Academy of Military Medical Sciences","OTHER"]