[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"plasma-cell-neoplasms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:plasma-cell-neoplasms":27},{"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":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100637392","early-phase-1-in-vivo-bcmagprc5d-tandem-dual-car-t-therapy-for-relapsedrefractory-plasma-cell-neoplasms-100637392",false,"NCT07586709","In Vivo BCMA\u002FGPRC5D Tandem Dual CAR-T Therapy for Relapsed\u002FRefractory Plasma Cell Neoplasms","A Clinical Study on the Safety of in Vivo-CAR-T Cell Immunotherapy Targeting BCMA\u002FGPRC5D for the Treatment of Relapsed\u002FRefractory Plasma Cell Neoplasms","Inclusion Criteria:\n\n* Voluntary signing of informed consent by the subject or legally authorized representative, with willingness and ability to comply with scheduled visits, study treatment, laboratory tests, and other study procedures.\n* Diagnosis of relapsed or refractory plasma cell neoplasms meeting the following criteria:\n\n  1. Clonal plasma cells confirmed to be BCMA and\u002For GPRC5D positive by flow cytometry or immunohistochemistry;\n  2. Previously treated with at least 2 lines of anti-plasma cell neoplasms therapy, with at least 1 complete treatment cycle for each line, and evidence of disease progression within 12 months after the most recent anti-plasma cell neoplasms treatment, or being refractory to both immunomodulatory drugs and proteasome inhibitors, with disease progression within 2 months after the most recent anti-plasma cell neoplasms treatment (according to the IMWG diagnostic criteria)\n* Age 18 to 75 years (inclusive), male or female.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Life expectancy \\> 3 months from the date of informed consent.\n* Hemoglobin (HGB) ≥ 60 g\u002FL (transfusion allowed).\n* Adequate organ function (hepatic, renal, cardiac, and pulmonary):\n\n  1. Creatinine ≤ 2 × ULN;\n  2. Left ventricular ejection fraction (LVEF) ≥ 50%;\n  3. Oxygen saturation \\> 90%;\n  4. Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN.\n* Willingness to use highly effective contraception from signing of informed consent until 1 year after SL4903 infusion.\n\nExclusion Criteria:\n\n* Severe cardiac dysfunction with left ventricular ejection fraction (LVEF) \\\u003C 50%.\n* History of severe pulmonary impairment.\n* Concurrent diagnosis of another active malignancy.\n* Uncontrolled active infection.\n* History of severe autoimmune disease or primary immunodeficiency.\n* Active hepatitis (defined as HBV DNA or HCV RNA above the lower limit of detection).\n* Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), or active syphilis.\n* History of severe hypersensitivity to biological products (including antibiotics).\n* Allogeneic hematopoietic stem cell transplant recipients with ongoing acute graft-versus-host disease (GVHD) despite discontinuation of immunosuppressive therapy for at least one month prior to screening.\n* Any other severe comorbidities or laboratory abnormalities that, in the investigator's opinion, would increase the risk to the subject or interfere with study results, rendering the subject unsuitable for participation.\n* Pregnant or breastfeeding women (including women of childbearing potential who are pregnant or lactating).","ALL","18 Years","75 Years",{"count":20,"type":21},18,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","This study aims to assess the safety profile of in vivo BCMA\u002FGPRC5D-targeted CAR-T cell immunotherapy in patients with relapsed or refractory plasma cell neoplasms.",[27],"Plasma Cell Neoplasms",[29,30,31,32],"in vivo CAR-T Cell Therapy","BCMA","GPRC5D","plasma cell neoplasms","NOT_YET_RECRUITING","2026-05-07",{"date":36,"type":37},"2026-05-14","ACTUAL",{"date":39,"type":21},"2026-05-09",{"date":41,"type":21},"2029-03-31",{"name":43,"class":44},"Liping Dou","OTHER"]