[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607202":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":19,"locations":19,"responsibleParty":20,"collaborators":19,"id":22,"slug":23,"hasResults":24,"nctId":25,"briefTitle":26,"officialTitle":27,"acronym":9,"eligibilityCriteria":28,"healthyVolunteers":24,"sex":29,"minAge":30,"maxAge":19,"enrollmentInfo":31,"targetDuration":19,"studyType":34,"phases":35,"briefSummary":37,"conditions":38,"keywords":19,"overallStatus":41,"whyStopped":19,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":19},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"IASO104","EXPERIMENTAL","IASO104 will be administered in one infusion.",[13],"Biological: IASO104",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","IASO104 is a personalized, BCMA-targeted, genetically modified autologous T-cell immunotherapy product.",[9],null,{"type":21,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100607202","early-phase-1-iaso104-for-the-treatment-of-patients-with-relapsedrefractory-multiple-myeloma-100607202",false,"NCT07185490","IASO104 for the Treatment of Patients With Relapsed\u002FRefractory Multiple Myeloma","Exploratory Clinical Study Protocol on the Safety and Efficacy of Fully Human BCMA-Targeted Chimeric Antigen Receptor Autologous T-Cell Injection (IASO104) for the Treatment of Patients With Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n1. Age 18-75 years, any gender.\n2. Diagnosis of multiple myeloma (MM) per International Myeloma Working Group (IMWG) diagnostic criteria.\n3. Prior therapy requirements:\n\n   MM patients: ≥3 prior lines of therapy, including:\n   * 1 proteasome inhibitor (PI)\n   * 1 immunomodulatory drug (IMiD)\n   * 1 anti-CD38 monoclonal antibody Exception: No minimum line requirement for subjects refractory to PIs, IMiDs, and anti-CD38 therapy.\n\n   Primary plasma cell leukemia (pPCL): ≥1 prior line including ≥1 PI and ≥1 IMiD.\n4. Documented disease progression during\u002Fwithin 12 months after last anti-myeloma therapy (exemption: No 12-month requirement if last line was CAR-T).\n5. Measurable disease at screening (≥1 of the following):\n\n   Serum M-protein:\n\n   IgG ≥10 g\u002FL IgA\u002FIgD\u002FIgE\u002FIgM ≥5 g\u002FL Urine M-protein ≥200 mg\u002F24h Serum free light chains (FLC): Involved FLC ≥100 mg\u002FL with abnormal κ\u002Fλ ratio Bone marrow plasma cells ≥30% (if no measurable M-protein\u002FFLC).\n6. ECOG performance status 0-1.\n7. Life expectancy ≥12 weeks.\n8. Adequate organ function (all lab values within 7 days prior to enrollment):\n\n   Hematology:\n\n   Absolute neutrophil count (ANC) ≥1×10⁹\u002FL (allowed: growth factor support, but none within 7 days) Absolute lymphocyte count (ALC) ≥0.3×10⁹\u002FL Platelets ≥50×10⁹\u002FL (no transfusion within 7 days) Hemoglobin ≥60 g\u002FL (no RBC transfusion within 7 days; erythropoietin allowed)\n\n   Liver:\n\n   ALT\u002FAST ≤2.5×ULN Total bilirubin ≤1.5×ULN Renal: Calculated CrCl ≥40 mL\u002Fmin (Cockcroft-Gault)\n\n   Coagulation:\n\n   Fibrinogen ≥1.0 g\u002FL aPTT\u002FPT ≤1.5×ULN Pulmonary: SpO₂ \\>91% (room air) Cardiac: LVEF ≥50% (echocardiography).\n9. Contraception: Subjects\u002Fpartners must use effective contraception from consent through 1 year post CAR-T infusion (excluded: calendar method).\n10. Signed informed consent approved by the Ethics Committee prior to screening.\n\nExclusion Criteria:\n\n1. Active graft-versus-host disease (GVHD) or requiring long-term immunosuppressive therapy.\n2. Prior hematopoietic stem cell transplantation (HSCT):\n\n   Autologous HSCT (Auto-HSCT) within 12 weeks before apheresis,\n\n   ≥2 prior Auto-HSCTs, Any prior allogeneic HSCT (Allo-HSCT).\n3. Prior cell therapy targeting plasma cells within 3 months before apheresis, or detectable residual cellular therapy products in peripheral blood.\n4. Recent anti-myeloma therapies (relative to apheresis):\n\n   Monoclonal antibody treatment within 21 days, Cytotoxic chemotherapy or proteasome inhibitors within 14 days, Immunomodulatory drugs within 7 days, Other anti-tumor therapies within 14 days or 5 half-lives (whichever is shorter).\n5. Chronic corticosteroid use (\\>20 mg\u002Fday prednisone or equivalent), except for physiologic replacement, topical, or inhaled use.\n6. Uncontrolled hypertension despite medication.\n7. Severe cardiac disease, including:\n\n   Unstable angina, Myocardial infarction (within 6 months before screening), Congestive heart failure (NYHA Class ≥III), Severe arrhythmias.\n8. Unstable systemic illnesses per investigator's judgment (e.g., severe hepatic, renal, or metabolic disorders requiring medication).\n9. Other malignancies within 5 years, excluding:\n\n   Carcinoma in situ of the cervix, Basal\u002Fsquamous cell skin cancer, Localized prostate cancer post-radical resection, Ductal breast carcinoma in situ post-resection.\n10. History of solid organ transplantation.\n11. Suspected or confirmed CNS involvement by plasma cell neoplasms.\n12. Major surgery within 2 weeks before apheresis or planned within 2 weeks post-treatment (allowed: minor procedures under local anesthesia).\n13. Investigational drugs within 1 month before apheresis.\n14. Uncontrolled active infections:\n\n    Persistent symptoms despite appropriate therapy, Requiring IV antimicrobials at screening.\n15. Viral infections:\n\n    HBV: HBsAg(+) or HBcAb(+) with detectable HBV DNA, HCV: HCV Ab(+) with detectable HCV RNA, HIV Ab(+), CMV DNA(+), Syphilis: TRUST(+) and TPPA(+).\n16. Pregnancy or lactation.\n17. Psychiatric disorders, cognitive impairment, or active CNS diseases.\n18. Other conditions deemed ineligible by the investigator.","ALL","18 Years",{"count":32,"type":33},40,"ESTIMATED","INTERVENTIONAL",[36],"EARLY_PHASE1","This study is a single-center, open-label, dose-exploration trial designed to evaluate the tolerability and safety of different doses of IASO104 in patients with relapsed\u002Frefractory plasma cell neoplasms, determine the recommended dose of IASO104, and assess its pharmacokinetic and pharmacodynamic characteristics. Additionally, the study will preliminarily observe the efficacy of the investigational drug in a small sample of subjects with relapsed\u002Frefractory multiple myeloma.",[39,40],"Relapsed\u002FRefractory Multiple Myeloma (RRMM)","Plasma Cell Leukemia (PCL)","NOT_YET_RECRUITING","2026-01-15",{"date":44,"type":45},"2026-01-20","ACTUAL",{"date":47,"type":33},"2026-02-15",{"date":49,"type":33},"2029-08-15",{"name":5,"class":6}]