[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsedrefractory-multiple-myeloma-rrmm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsedrefractory-multiple-myeloma-rrmm":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,39,63,91,119,143,162],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100644052","phase-1-a-phase-i-open-label-multicenter-study-to-evaluate-the-safety-and-tolerability-of-bp2202-in-patients-with-relapsedrefractory-multiple-myeloma-100644052",false,"NCT07667868","A Phase I, Open-label, Multicenter Study to Evaluate the Safety and Tolerability of BP2202 in Patients With Relapsed\u002FRefractory Multiple Myeloma","A Phase I, Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of BP2202 in Patients With Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n* Diagnosis of Multiple Myeloma with relapsed or refractory disease.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1\n* Adequate organ function.\n* Have measurable disease\n\nExclusion Criteria:\n\n* Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of Multiple Myeloma.\n* Known second malignancy that is progressing or requires active treatment or may interfere with study endpoints.","ALL","18 Years",{"count":19,"type":20},18,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The purpose of this study is to find out if BP2202 is safe and can treat participants with Relapsed\u002FRefractory Multiple Myeloma.",[26],"Relapsed\u002FRefractory Multiple Myeloma (RRMM)","NOT_YET_RECRUITING","2026-06-29",{"date":30,"type":31},"2026-07-01","ACTUAL",{"date":33,"type":20},"2026-10-01",{"date":35,"type":20},"2028-12-31",{"name":37,"class":38},"BrightPath Biotherapeutics Co., Ltd.","INDUSTRY",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":4,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":62},"100538014","a-study-of-clinical-outcomes-in-patients-with-relapsedrefractory-multiple-myeloma-rrmm-treated-with-t-cell-redirectors-outside-of-clinical-trials-100538014","NCT06285318","A Study of Clinical Outcomes in Patients With Relapsed\u002FRefractory Multiple Myeloma (RRMM) Treated With T-cell Redirectors Outside of Clinical Trials","A Retrospective, Multicountry Study of Clinical Outcomes in Patients With Relapsed\u002FRefractory Multiple Myeloma Treated With T-cell Redirectors Outside of Clinical Trials","REALiTEC\u002FTAL","Inclusion Criteria:\n\n* Have a documented diagnosis of multiple myeloma\n* Received the first dose of teclistamab on or before 31 December 2022, regardless of the duration of teclistamab treatment (REALiTEC cohort 1) OR Received the first dose of teclistamab from 01 January 2023 to 31 December 2024, inclusive, regardless of the duration of teclistamab treatment (REALiTEC cohort 2) OR Received the first dose of teclistamab from 01 January 2025 to 31 December 2025, inclusive, regardless of the duration of teclistamab treatment (REALiTEC cohort 3) OR Received the first dose of talquetamab on or before 31 December 2023, regardless of the duration of talquetamab treatment (REALiTAL cohort). Participants who received both teclistamab \\& talquetamab can be included in both REALiTEC and REALiTAL cohorts\n* Received at least one dose of teclistamab\u002Ftalquetamab\n* Provision of a patient-signed informed consent form (ICF), or an ICF waiver for deceased patients as applicable based on country\u002Fsite-specific requirements\n\nExclusion Criteria:\n\n* To be excluded from REALiTEC cohorts if received teclistamab as part of an interventional clinical trial\n* To be excluded from REALiTAL cohort if received talquetamab as part of an interventional clinical trial\n* Participants who have received teclistamab as part of a Janssen pre-approval access program are excluded from the REALiTEC Cohort 2 and REALiTEC Cohort 3",{"count":48,"type":20},900,"OBSERVATIONAL","The purpose of this study is to describe the use of teclistamab\u002Ftalquetamab in the treatment of patients with RRMM outside of clinical trials.",[26],"RECRUITING","2026-06-04",{"date":55,"type":31},"2026-06-05",{"date":57,"type":31},"2023-12-18",{"date":59,"type":20},"2026-09-24",{"name":61,"class":38},"Janssen-Cilag Ltd.",68,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":73,"briefSummary":75,"conditions":76,"keywords":77,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":4},"100638612","phase-4-adult-outpatient-linvoseltamab-with-tocilizumab-prophylaxis-to-mitigate-the-risk-of-cytokine-release-syndrome-crs-100638612","NCT07609940","Adult Outpatient Linvoseltamab With Tocilizumab Prophylaxis to Mitigate the Risk of Cytokine Release Syndrome (CRS)","A Phase 4, Single-Arm, Multicenter Study of Prophylactic Tocilizumab in Participants With Relapsed\u002FRefractory Multiple Myeloma Treated With Linvoseltamab in the Outpatient Setting","POPLIN","Key Inclusion Criteria:\n\n1. Disease progression on or after at least 4 prior lines of therapy including a(n) Protease Inhibitor (PI), Immunomodulatory imide Drug (IMiD), and anti-CD 38 antibody\n2. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2\n3. Confirmed progressive disease according to IMWG criteria during or after the most recent line of therapy\n\nKey Exclusion Criteria:\n\n1. Diagnosis of plasma cell leukemia, symptomatic amyloidosis (including myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin changes (POEMS) syndrome\n2. Known myeloma brain lesions or meningeal involvement\n3. History of neurodegenerative condition, Progressive Multifocal Leukoencephalopathy \\[PML\\], or Central Nervous System (CNS) movement disorder\n\nNOTE: Other protocol defined inclusion\u002Fexclusion criteria apply",{"count":72,"type":20},30,[74],"PHASE4","This study is researching whether the use of tocilizumab before the first dose of linvoseltamab will decrease the risk of Cytokine Release Syndrome (CRS) in participants who have Relapsed or Refractory Multiple Myeloma (RRMM) who have already been treated with at least four lines of treatment for their multiple myeloma, including medicines called a proteasome inhibitor, an immunomodulatory drug, and an anti-Cluster of Differentiation (CD) 38 antibody.\n\nThe aim of the study is to see how safe, tolerable and effective linvoseltamab is when given after tocilizumab.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking tocilizumab before the first dose of linvoseltamab\n* Whether tocilizumab has an impact on CRS, including whether participants require hospital care and, if so, how many hospital visits occur and how long they last\n* How frequently other medications (for example, corticosteroids or additional doses of tocilizumab) are used to support participants' care if needed",[26],[78,79,80,81],"Cytokine Release Syndrome (CRS)","Linvoseltamab","Tocilizumab","Bispecific antibodies","2026-05-20",{"date":84,"type":31},"2026-05-27",{"date":86,"type":20},"2026-07-17",{"date":88,"type":20},"2028-12-06",{"name":90,"class":38},"Regeneron Pharmaceuticals",{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":98,"enrollmentInfo":99,"targetDuration":101,"studyType":49,"phases":4,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":118},"100631168","epunamin-combined-with-decp-for-relapsedrefractory-multiple-myeloma-100631168","NCT07497165","Epunamin Combined With DECP for Relapsed\u002FRefractory Multiple Myeloma","A Multicenter Real-World Study Evaluating Epunamin in Combination With a DECP-Based Regimen for Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\nAdults aged 18 to 75 years with relapsed\u002Frefractory Multiple Myeloma diagnosed according to revised IMWG criteria.\n\nReceived at least one prior systemic treatment regimen. Eastern Cooperative Oncology Group Performance Status score of 0-3. Able to understand treatment-related changes and management options during therapy and follow-up, with good treatment adherence and follow-up compliance.\n\nProvided written informed consent. -\n\nExclusion Criteria:\n\nSevere dysfunction of major organs, including cardiac, pulmonary, hepatic, or renal impairment, defined as left ventricular ejection fraction \\\u003C50%, diffusion capacity for carbon monoxide \\\u003C50% of predicted value due to chronic respiratory disease, serum bilirubin \\>2 mg\u002FdL, alanine aminotransferase or aspartate aminotransferase \\>2.5 × upper limit of normal, or estimated glomerular filtration rate \\\u003C30 mL\u002Fmin.\n\nToxicities from prior chemotherapy not recovered to baseline or grade ≤1. Peripheral neuropathy grade ≥2, or grade 1 with pain. Major surgery, radiotherapy, infection requiring systemic antibiotic treatment, or other severe infection within 14 days before enrollment.\n\nHigh-risk plasma cell leukemia with peripheral blood plasma cells ≥20%. Psychiatric disorders, cognitive impairment, or other conditions affecting self-control or study compliance.\n\nPregnant or breastfeeding women, or fertile patients unwilling to use adequate contraception during the study. Male patients unwilling to use effective contraception or refrain from sperm donation during treatment and for 3 months after the last dose.\n\nDiagnosis or treatment of another malignancy within 2 years before enrollment. Known hypersensitivity to Epunamin, Dexamethasone, Cisplatin, Etoposide, or Cyclophosphamide.\n\nHuman Immunodeficiency Virus Infection positive. Participation in another clinical trial within 30 days before enrollment or during the study period.\n\nAny condition considered unsuitable for participation by the investigator.","75 Years",{"count":100,"type":20},48,"17 Months","Background:\n\nMultiple Myeloma remains an incurable hematologic malignancy, and outcomes for relapsed\u002Frefractory multiple myeloma (RRMM) remain unsatisfactory despite advances in therapy. This study aims to evaluate the efficacy and safety of Epunamin combined with a DECP-based regimen in a real-world clinical setting.\n\nMethods:\n\nThis multicenter, single-arm, real-world observational study will enroll 48 patients aged 18-75 years with RRMM diagnosed according to revised IMWG criteria who have received at least one prior systemic treatment. Eligible patients must have an ECOG performance status of 0-3, adequate treatment compliance, and written informed consent.\n\nKey exclusion criteria include severe cardiac, pulmonary, hepatic, or renal dysfunction; unresolved prior treatment toxicity above grade 1; grade ≥2 peripheral neuropathy or grade 1 with pain; severe infection within 14 days; plasma cell leukemia; psychiatric disorders affecting compliance; pregnancy or lactation; recent other malignancies; hypersensitivity to study drugs; HIV infection; participation in another clinical trial within 30 days; or any condition deemed unsuitable by investigators.\n\nEndpoints:\n\nThe primary endpoint is overall response rate (ORR) after four treatment cycles. Secondary endpoints include very good partial response (VGPR), complete response (CR), stringent complete response (sCR), minimal residual disease (MRD), duration of response (DOR), and time to next treatment (TTNT), assessed according to revised IMWG criteria.\n\nStatistical Analysis:\n\nContinuous variables will be summarized using mean, median, standard deviation, minimum, and maximum values. Normally distributed data will be analyzed using Student's t-test or ANOVA, while non-normally distributed data will use rank-sum tests. Categorical variables will be analyzed using chi-square or Fisher's exact tests, and ordinal variables by Ridit analysis or nonparametric tests. Survival outcomes including progression-free survival (PFS) and overall survival (OS) will be estimated using Kaplan-Meier analysis and compared by log-rank test. A two-sided P value \\\u003C0.05 will be considered statistically significant.\n\nStudy Period:\n\nOctober 2025 to September 2027.",[26,104],"Multiple Myeloma",[106,107,104],"Epunamin","DECP-Based Regimen","2026-03-23",{"date":110,"type":31},"2026-03-27",{"date":112,"type":31},"2025-11-01",{"date":114,"type":20},"2027-06-30",{"name":116,"class":117},"Shanxi Bethune Hospital","OTHER",1,{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":21,"phases":129,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":4},"100607202","early-phase-1-iaso104-for-the-treatment-of-patients-with-relapsedrefractory-multiple-myeloma-100607202","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","IASO104","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.",{"count":128,"type":20},40,[130],"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.",[26,133],"Plasma Cell Leukemia (PCL)","2026-01-15",{"date":136,"type":31},"2026-01-20",{"date":138,"type":20},"2026-02-15",{"date":140,"type":20},"2029-08-15",{"name":142,"class":117},"Institute of Hematology & Blood Diseases Hospital, China",{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":98,"enrollmentInfo":150,"targetDuration":4,"studyType":21,"phases":152,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":159,"leadSponsor":161,"locationsCount":4},"100617710","early-phase-1-iaso206-in-patients-with-relapsedrefractory-multiple-myeloma-100617710","NCT07322159","IASO206 in Patients With Relapsed\u002FRefractory Multiple Myeloma","An Exploratory Study of Safety and Efficacy of IASO206 in Patients With Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n* 18 to 75 years old, male or female;\n* Diagnosed with relapsed\u002Frefractory multiple myeloma (RRMM) according to IMWG criteria, and have received at least 2 lines of treatment including one proteasome inhibitor and one immunomodulator; with documented disease progression (based on examination data) during or within 12 months after the latest anti-myeloma treatment (subjects whose last-line treatment was CAR-T therapy are not required to have progression within 12 months);\n* Presence of measurable lesions during screening according to any of the following criteria:\n\n  * Serum monoclonal protein (M-protein) level: ≥5 g\u002FL f；\n  * Urine M protein level ≥200 mg\u002F24 hours;\n  * Light chain multiple myeloma without measurable lesions in serum or urine: the affected serum free light chain ≥100 mg\u002FL with abnormal serum κ\u002Fλ free light chain ratio;\n* BCMA expression on MM cells determined by flow cytometry or pathology immunohistochemistry;\n* ECOG score ≤ 2;\n* Expected survival time ≥12 weeks;\n* Subjects must have adequate organ function:\n* Hematology: Absolute neutrophil count (ANC) ≥ 1×10\\^9\u002FL (supportive treatment within 7 days before laboratory test is not allowed); Absolute lymphocyte count (ALC) )≥0.3×10\\^9\u002FL; platelets≥50×10\\^9\u002FL (blood transfusion support within 7 days before laboratory test is not allowed); hemoglobin ≥60 g\u002FL (without red blood cell \\[RBC\\] transfusion within 7 days before laboratory test);\n\n  * Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤1.5×upper limit of normal (ULN); serum total bilirubin≤1.5×ULN;\n  * Renal function: creatinine clearance calculated according to Cockcroft-Gault formula≥ 40 ml\u002Fmin.\n  * Coagulation function: fibrinogen ≥1.0 g\u002FL; activated partial thromboplastin time≤1.5×ULN, prothrombin time (PT)≤1.5×ULN;\n  * Blood oxygen saturation\\>91%;\n  * Left ventricular ejection fraction (LVEF) ≥50%;\n* Subjects and their spouses agree to use effective contraceptive methods with tools or drugs from the time the subject signs the informed consent form until one year after administration;\n* Subjects must sign a written informed consent form approved by the ethics committee before initiating the screening process.\n\nExclusion Criteria:\n\n* Patients with suspected or confirmed central nervous system involvement by plasma cell neoplasms;\n* Multiple myeloma patients with plasma cell leukemia;\n* Patients with amyloidosis;\n* Patients who have received autologous hematopoietic stem cell transplantation (Auto-HSCT) within 12 weeks before enrollment, or have a history of allogeneic hematopoietic stem cell transplantation (Allo-HSCT);\n* Patients who have received previous BCMA-targeted therapy;\n* Patients who have received plasma cell-targeted cellular therapy within 3 months before the screening period, or in whom received cellular therapy products can still be detected in peripheral blood;\n* Patients who have received other anti-tumor treatments requires an appropriate washout period：\n\n  * Received Bendamustine, fludalabine or high-dose cyclophosphoyl within 9 months before enrollment，or；\n  * Received Monoclonal antibody treatment for multiple myeloma within 21 days before enrollment, or;\n  * Received cytotoxic chemotherapy or proteasome inhibitor treatment within 14 days before enrollment, or；\n  * Received immunomodulatory treatment within 7 days before enrollment, or;\n  * Received other anti-tumor treatments (including but not limited to experimental drugs) listed above within 14 days before enrollment or at least 5 half-lives (whichever is longer);\n* Patients requiring long-term use of therapeutic doses of corticosteroids during the study period (defined as prednisone or equivalent \\>20 mg\u002Fday), except for physiological replacement, topical, and inhaled use;\n* Severe heart diseases：including but not limited to unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥ grade III), severe arrhythmia，hypertension that cannot be controlled by medication;\n* Unstable systemic diseases judged by the investigator: including but not limited to severe liver, kidney or metabolic diseases；\n* Patient who needs chronic use of immunosuppressive agents;\n* Patients with malignant tumors other than multiple myeloma within 5 years before screening, excluding fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, and those after radical resection Ductal carcinoma in situ of breast and papillary thyroid carcinoma;\n* Patients with a history of solid organ transplantation;\n* Major surgery history within 2 weeks before entering the study, or scheduled surgery during the study period or within 2 weeks after the study treatment；\n* Serious uncontrolled infections during screening: Bacterial, viral, fungal, etc. infections;\n* Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and detectable hepatitis B virus (HBV) DNA in peripheral blood; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus ( HCV) RNA positive; human immunodeficiency virus (HIV) antibody positive; cytomegalovirus (CMV) DNA test positive; syphilis test positive;\n* Patients who have received inactivated vaccines within 4 weeks before enrollment;\n* Women who are pregnant or breastfeeding;\n* Patients with mental illness, consciousness disorder, or central nervous system diseases, including but not limited to epilepsy or a history of Parkinson's disease;\n* Known severe allergic reaction to IASO206 or its formulation components (such as tocilizumab);\n* Patients with unresolved non-hematological toxic reactions from previous treatments, which have not returned to baseline or ≤Grade 1 (except for alopecia and Grade 2 peripheral neuropathy);\n* Other situations considered unsuitable by the investigator.",{"count":151,"type":20},12,[130],"This study is an open-label, single-arm early exploratory clinical study, aiming to evaluate the safety, tolerability and preliminary efficacy of IASO206 Injection(In Vivo CAR-T) in Patients with Relapsed\u002FRefractory Multiple Myeloma",[26],"2025-12-22",{"date":157,"type":31},"2026-01-07",{"date":134,"type":20},{"date":160,"type":20},"2028-10-15",{"name":142,"class":117},{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":21,"phases":171,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":178,"leadSponsor":180,"locationsCount":4},"100607201","early-phase-1-a-single-arm-single-center-trial-of-bridging-gprc5dcd3-bispecific-antibody-treatment-with-bcma-car-t-cell-therapy-for-relapsedrefractory-multiple-myeloma-100607201","NCT07185477","A Single-arm Single-center Trial of Bridging GPRC5D\u002FCD3 Bispecific Antibody Treatment With BCMA CAR-T Cell Therapy for Relapsed\u002FRefractory Multiple Myeloma","QLS32015","Inclusion Criteria:\n\n1. Voluntary Participation: Ability to understand and voluntarily sign the informed consent form (ICF).\n2. Age ≥18 years.\n3. Confirmed symptomatic MM diagnosis per the Chinese Guidelines for Diagnosis and Management of Multiple Myeloma (2022 Revision).\n4. Relapsed\u002FRefractory MM (RRMM) meeting one of the following:\n\n   Triple-class refractory RRMM: Resistant to ≥1 immunomodulatory drug (IMiD), ≥1 proteasome inhibitor (PI), and ≥1 anti-CD38 monoclonal antibody.\n\n   Penta-drug refractory RRMM: Resistant to ≥2 IMiDs, ≥2 PIs, and ≥1 anti-CD38 antibody.\n\n   Secondary plasma cell leukemia (sPCL):\n\n   MM diagnosis per Chinese Guidelines (2022), plus Peripheral blood plasma cells ≥20% of leukocytes or absolute circulating plasma cells \\>2×10⁹\u002FL.\n5. Successful apheresis for CAR-T cell manufacturing.\n6. ECOG performance status ≤3.\n7. No active infections:\n\n   HBV-DNA negative, HCV-RNA negative, HIV negative.\n8. Liver function:\n\n   Total bilirubin \\\u003C1.5×ULN (\\\u003C3×ULN for Gilbert's syndrome). AST\u002FALT \\\u003C3×ULN.\n9. Renal function: Calculated CrCl ≥30 mL\u002Fmin (Cockcroft-Gault formula).\n10. Baseline oxygen saturation \\>92% (room air).\n11. Hematologic criteria (within 7 days of screening):\n\nWBC ≥1.0×10⁹\u002FL, ANC ≥1.0×10⁹\u002FL, hemoglobin ≥70 g\u002FL, and Platelets ≥75×10⁹\u002FL (or ≥50×10⁹\u002FL if bone marrow plasma cells ≥50%). Investigator discretion permitted for clinical justification. 12.Growth factor restrictions: 2-week washout required for erythropoietin, G-CSF, GM-CSF, or thrombopoietin agonists (e.g., eltrombopag).\n\n13.Reproductive requirements: Non-childbearing women eligible; Childbearing potential women: Negative serum\u002Furine pregnancy test (β-hCG) at screening.\n\n14.Contraception: Males\u002Ffemales of reproductive potential must use effective contraception (per investigator judgment) during treatment and for ≥3 months post CAR-T infusion.\n\n15.Sperm donation prohibition: Males must refrain from sperm donation from screening until 90 days post-treatment.\n\n16.Compliance: Willing and able to complete study procedures and follow-up.\n\nExclusion Criteria:\n\n1. Prior GPRC5D-targeted immunotherapy.\n2. Investigator-assessed contraindications to GPRC5D×CD3 bispecific antibody therapy (e.g., severe cardiopulmonary diseases incompatible with treatment).\n3. Grade \\>2 peripheral neuropathy or ≥grade 2 painful neuropathy at screening (regardless of current medication).\n4. Known intolerance, hypersensitivity, or contraindication to GPRC5D×CD3 bispecific antibody components.\n5. Initiation of bridging therapy for BCMA CAR-T cell treatment.\n6. Unstable\u002Factive cardiovascular or cerebrovascular disease, including any of:\n\n   1. Unstable angina, symptomatic myocardial ischemia, myocardial infarction, or coronary revascularization within 180 days prior to first dose.\n   2. Uncontrolled hypertension (\\>140\u002F90 mmHg with historical readings \\>180\u002F100 mmHg within 6 months).\n   3. Clinically significant uncontrolled arrhythmias (excluded: asymptomatic 1st-degree AV block or LAFB\u002FRBBB).\n   4. LVEF \\\u003C40% by echocardiography.\n   5. Stroke or intracranial hemorrhage within 12 months before screening.\n   6. Pre-treatment severe thrombotic events.\n7. Active HIV infection or seropositivity.\n8. Active HBV\u002FHCV infection:\n\n   HBV: HBsAg(+) requires confirmed negative HBV-DNA PCR (allowed: if on antiviral therapy with confirmed suppression).\n\n   HCV: HCV Ab(+) requires negative HCV-RNA PCR.\n9. Pregnancy or lactation.\n10. Active gastrointestinal disorders affecting swallowing or drug absorption.\n11. Major surgery within 2 weeks pre-enrollment or planned during study (excluded: kyphoplasty\u002Fvertebroplasty; allowed: local anesthesia procedures).\n12. Live vaccines within 4 weeks before first study dose.\n13. Active psychiatric\u002Fmedical conditions impairing compliance\u002Fconsent capacity per investigator judgment.\n14. Contraindications to required concomitant medications\u002Fsupportive care.\n15. Any condition interfering with study procedures.\n16. Inability\u002Funwillingness to comply with protocol.",{"count":170,"type":20},20,[130],"This study is a prospective, single-arm, multicenter trial designed to evaluate the hematologic response rate and safety of GPRC5D\u002FCD3 bispecific antibody bridging therapy prior to CAR-T cell infusion in patients with relapsed\u002Frefractory multiple myeloma (RRMM).",[26],"2025-09-15",{"date":176,"type":31},"2025-09-22",{"date":174,"type":20},{"date":179,"type":20},"2028-05-31",{"name":142,"class":117}]