[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsed-or-refractory-plasma-cell-neoplasms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsed-or-refractory-plasma-cell-neoplasms":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,72],{"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":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100632861","early-phase-1-car-70-bcma-car-t-cells-for-the-treatment-of-relapsed-or-refractory-plasma-cell-neoplasms-100632861",false,"NCT07519187","CAR 70-BCMA CAR-T Cells for the Treatment of Relapsed or Refractory Plasma Cell Neoplasms","Clinical Study on the Safety and Efficacy of CAR 70-BCMA Dual-Target CAR-T Therapy for Relapsed or Refractory Plasma Cell Neoplasms","Inclusion Criteria:\n\n1. The subject or their legally authorized representative has provided written informed consent and is willing and able to comply with scheduled visits, study treatment, laboratory tests, and other study procedures\n2. Diagnosis of relapsed or refractory plasma cell neoplasms, defined as follows:\n\n   * Clonal plasma cells positive for BCMA and\u002For CD70 expression as determined by flow cytometry or immunohistochemistry\n   * Patients with multiple myeloma, plasmacytoma, or plasma cell leukemia who have received at least three prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody, and whose best response was less than partial response (PR) or who experienced disease progression after achieving at least PR\n   * Patients with systemic light chain amyloidosis who have received at least two prior lines of therapy, including an anti-CD38 monoclonal antibody and either a proteasome inhibitor (PI) or an immunomodulatory agent (IMiD), and whose best response was less than partial response (PR) or who experienced disease progression after achieving at least PR\n3. Aged 18 to 75 years (inclusive), male or female\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n5. Life expectancy greater than 3 months from the date of informed consent\n6. Hemoglobin (HGB) ≥ 60 g\u002FL (transfusion permitted)\n7. Adequate hepatic, renal, cardiac, and pulmonary function meeting the following criteria:\n\n   * Creatinine ≤ 2 × upper limit of normal (ULN)\n   * Left ventricular ejection fraction (LVEF) ≥ 50%\n   * Oxygen saturation \\> 90%\n   * Total bilirubin ≤ 1.5 × ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN\n8. The subject agrees to use contraceptive measures from the time of signing the informed consent form until 1 year after CAR-T cell infusion\n\nExclusion Criteria:\n\n* Severe cardiac dysfunction with left ventricular ejection fraction (LVEF) \\\u003C 50%\n* History of severe pulmonary function impairment\n* Concurrent progressive malignancy\n* Concurrent severe infection that cannot be adequately controlled\n* Concurrent severe autoimmune disease or congenital immunodeficiency\n* Active hepatitis, defined as hepatitis B virus deoxyribonucleic acid (HBV-DNA) or hepatitis C virus ribonucleic acid (HCV-RNA) 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 allergic reaction to biological products (including antibiotics)\n* Patients who have undergone allogeneic hematopoietic stem cell transplantation and still have acute graft-versus-host disease (GVHD) one month after discontinuation of immunosuppressive agents\n* Presence of any other serious physical or mental illness, or laboratory abnormality that may increase the risk of study participation, interfere with the interpretation of study results, or render the patient unsuitable for study enrollment in the opinion of the investigator\n* Female patients of childbearing potential who are pregnant or breastfeeding","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 CAR70-BCMA dual-target CAR-T cell therapy for relapsed and refractory plasma cell neoplasms.",[27],"Relapsed or Refractory Plasma Cell Neoplasms",[29,30,31,32],"Relapsed and Refractory Plasma Cell Neoplasms.","BCMA","CD70","CAR-T","RECRUITING","2026-06-05",{"date":36,"type":37},"2026-06-09","ACTUAL",{"date":39,"type":37},"2026-04-23",{"date":41,"type":21},"2028-04-01",{"name":43,"class":44},"The General Hospital of Western Theater Command","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":45},"100591900","early-phase-1-car19bcma-car-t-cells-for-the-treatment-of-rr-plasma-cell-neoplasms-and-lymphomasleukemias-with-plasmacytic-differentiation-100591900","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",{"count":20,"type":21},[24],"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.",[27,57],"Lymphomas\u002FLeukemias With Plasmacytic Differentiation",[32,59,60,61],"plasma cell neoplasms","CD19\u002FBCMA","lymphomas\u002Fleukemias with plasmacytic differentiation","NOT_YET_RECRUITING","2026-04-07",{"date":65,"type":37},"2026-04-08",{"date":67,"type":21},"2026-04-02",{"date":69,"type":21},"2028-08-25",{"name":71,"class":44},"Affiliated Hospital to Academy of Military Medical Sciences",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":82,"conditions":83,"keywords":84,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100598887","early-phase-1-car19bcma-car-t-cells-for-the-treatment-of-rr-plasma-cell-neoplasms-100598887","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.",{"count":20,"type":21},[24],"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.",[27],[32,59,60],"2025-07-21",{"date":87,"type":37},"2025-07-22",{"date":89,"type":21},"2025-08-01",{"date":91,"type":21},"2027-08-01",{"name":93,"class":44},"Chinese PLA General Hospital",2]