[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"plasma-cell-leukemia-pcl\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:plasma-cell-leukemia-pcl":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,46,78,105,128],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100641588","phase-2-cm336-plus-isa-vr-in-newly-diagnosed-primary-plasma-cell-leukemia-100641588",false,"NCT07652905","CM336 Plus Isa-VR in Newly Diagnosed Primary Plasma Cell Leukemia","A Prospective, Single-Arm, Single-Center, Phase II Study Evaluating the Safety and Efficacy of CM336 in Combination With Isatuximab, Lenalidomide, and Bortezomib in Newly Diagnosed Primary Plasma Cell Leukemia","CAREMM-011","Inclusion Criteria:\n\n1. Able to understand and voluntarily sign a written informed consent form (ICF).\n2. Age 18 to 75 years.\n3. Newly diagnosed primary plasma cell leukemia (pPCL) according to International Myeloma Working Group (IMWG) criteria, defined as either:\n\n   * ≥5% circulating plasma cells on peripheral blood smear; or\n   * Absolute circulating plasma cell count \\>2 × 10⁹\u002FL.\n\n   Patients who have received no more than one prior cycle of anti-myeloma therapy before enrollment are eligible, provided they have not received monoclonal antibodies or immunotherapy agents.\n4. Measurable disease, defined by at least one of the following:\n\n   * Serum M-protein ≥10 g\u002FL as measured by serum protein electrophoresis (SPEP); for IgA or IgD myeloma, quantitative IgA or IgD levels may be used instead;\n   * Urine M-protein ≥200 mg\u002F24 hours;\n   * If neither serum nor urine M-protein meets the above criteria, involved serum free light chain (FLC) ≥100 mg\u002FL with an abnormal serum FLC ratio (normal range: 0.26-1.65).\n5. Adequate hepatic function, defined as:\n\n   * Total bilirubin \\\u003C1.5 × upper limit of normal (ULN), except for participants with Gilbert syndrome, who must have total bilirubin \\\u003C3 × ULN;\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN.\n6. Adequate renal function, defined as creatinine clearance ≥30 mL\u002Fmin, calculated using the Cockcroft-Gault formula.\n7. Adequate hematologic function within 7 days prior to enrollment, defined as:\n\n   * White blood cell (WBC) count ≥1.5 × 10⁹\u002FL;\n   * Absolute neutrophil count (ANC) ≥1.0 × 10⁹\u002FL;\n   * Hemoglobin ≥70 g\u002FL;\n   * Platelet count ≥50 × 10⁹\u002FL;\n\n   Alternatively, eligibility may be determined by the investigator based on clinical judgment.\n8. Participants receiving hematopoietic growth factor support, including erythropoietin, granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), or thrombopoietic agents, must have a washout period of at least 2 weeks between the last administration of growth factor support and screening assessments.\n9. Participants receiving blood product transfusions must meet the following requirements:\n\n   * At least 2 weeks between the last red blood cell (RBC) transfusion and hemoglobin assessment at screening;\n   * At least 1 week between the last platelet transfusion and platelet count assessment at screening.\n10. Able and willing to receive protocol-recommended prophylactic anticoagulation therapy.\n11. Female participants of childbearing potential must have a negative serum pregnancy test at screening and agree to use effective contraception from the time of signing the informed consent form, throughout study treatment, and for at least 3 months after the last dose of study treatment.\n\nMale participants, including those who have undergone vasectomy, must agree to use condoms during sexual intercourse with women of childbearing potential and must not plan to father a child from the time of signing informed consent through 3 months after the last dose of study treatment.\n\nExclusion Criteria:\n\n1. Diagnosis of smoldering multiple myeloma (SMM), monoclonal gammopathy of undetermined significance (MGUS), Waldenström macroglobulinemia, POEMS syndrome, amyloidosis, or secondary plasma cell leukemia.\n2. Central nervous system (CNS) involvement or clinical evidence of leptomeningeal involvement.\n3. Known intolerance, hypersensitivity, allergy, or contraindication to CM336, isatuximab, bortezomib or lenalidomide.\n4. Severe and\u002For uncontrolled cardiovascular disease, including:\n\n   Unstable angina; Symptomatic congestive heart failure; Myocardial infarction within 6 months prior to enrollment; Severe and uncontrolled cardiac arrhythmias; Any other cardiovascular or cerebrovascular condition deemed by the investigator to make participation inappropriate.\n5. Active infection, including:\n\n   Human immunodeficiency virus (HIV) infection; Active hepatitis B infection (HBV DNA positive); Active hepatitis C infection (HCV RNA positive); Active or latent syphilis infection (positive Treponema pallidum antibody test); Active pulmonary tuberculosis, as evidenced by chest imaging or other relevant assessments within 3 months prior to screening or during the screening period; Any other infection considered by the investigator to make participation inappropriate.\n6. Concurrent active malignancy or any serious concomitant disease that, in the investigator's judgment, could compromise participant safety or interfere with study participation.\n7. Pregnant or breastfeeding women.\n8. Estimated life expectancy of less than 6 months.\n9. Active gastrointestinal disorders that may impair the participant's ability to swallow oral medication or may interfere with the absorption of study treatment.\n10. Major surgery within 2 weeks prior to enrollment (e.g., surgery requiring general anesthesia), incomplete recovery from prior surgery, or planned major surgery during study participation. Kyphoplasty and vertebroplasty are not considered major surgery. Participants undergoing procedures under local anesthesia may be eligible.\n11. Receipt of a live attenuated vaccine within 4 weeks before the first dose of study treatment.\n12. Any active severe psychiatric disorder, medical condition, symptom, or other circumstance that, in the investigator's judgment, may interfere with treatment, protocol compliance, or the ability to provide informed consent.\n13. Inability or unwillingness to provide written informed consent.","ALL","18 Years","75 Years",{"count":21,"type":22},24,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The goal of this clinical trial is to learn whether CM336, a BCMA\u002FCD3 bispecific antibody, can improve treatment outcomes when combined with isatuximab, lenalidomide, and bortezomib in adults with newly diagnosed primary plasma cell leukemia (pPCL). The study will also evaluate the safety of this treatment combination.\n\nThe main questions it aims to answer are:\n\nHow many participants achieve minimal residual disease (MRD) negativity after 9 treatment cycles? What side effects occur during treatment with CM336 combined with isatuximab, lenalidomide, and bortezomib? How many participants respond to treatment, and how long do those responses last? How long do participants remain free from disease progression, and how long do they survive after starting treatment? All participants will receive the study treatment. There is no comparison group in this study.\n\nParticipants will:\n\nReceive CM336 by subcutaneous injection together with isatuximab, lenalidomide, and bortezomib in 28-day treatment cycles.\n\nUndergo regular blood tests, bone marrow examinations, and disease assessments to monitor treatment response and safety.\n\nHave stem cells collected after the first 3 treatment cycles if appropriate. Continue treatment for up to 18 cycles, followed by maintenance treatment with isatuximab and lenalidomide until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision.\n\nBe monitored throughout the study for side effects.",[28],"Plasma Cell Leukemia (PCL)",[30,31,32],"BCMA\u002FCD3 bispecific antibody","CM336","Primary plasma cell leukemia","NOT_YET_RECRUITING","2026-06-11",{"date":36,"type":37},"2026-06-17","ACTUAL",{"date":39,"type":22},"2026-06-20",{"date":41,"type":22},"2031-12-30",{"name":43,"class":44},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100641948","phase-3-personalising-treatment-for-myeloma-patients-based-on-initial-response-to-nhs-treatment-and-their-overall-fitness-level-100641948","NCT07649525","Personalising Treatment for Myeloma Patients Based on Initial Response to NHS Treatment and Their Overall Fitness Level","iFIT (UK-MRA Myeloma XVIII): Immunotherapy Approaches Adapted for Fitness in Newly Diagnosed Transplant Ineligible Patients With Myeloma","iFIT","Eligibility criteria for registration:\n\nInclusion criteria for registration:\n\n1. Newly diagnosed as having symptomatic MM, plasma cell leukaemia or non-secretory MM according to IMWG diagnostic criteria 2014.\n2. Considered not suitable to receive autologous stem cell transplant as part of their first line therapy by the treating clinician,\n3. Planned for treatment with Daratumumab, Lenalidomide and dexamethasone (DRd) as first line therapy as standard of care,\n4. Aged 18 years or greater,\n5. Able to provide full informed consent, and\n6. Prepared to comply with pregnancy prevention plan.\n\nExclusion criteria for registration:\n\n1. Smouldering myeloma (SMM), primary amyloidosis, solitary plasmacytoma of bone or extramedullary plasmacytoma (without additional evidence of myeloma),\n2. Pregnant, breastfeeding, plans to become pregnant, or plans to father a child whilst enrolled in the study or within 3 months after the last dose,\n3. Previous treatment for myeloma, except as specified in the protocol,\n4. Active systemic viral, fungal or bacterial infection requiring systemic therapy. Criteria for specific chronic infections clarified in the protocol, or\n5. Participation in any other interventional study for myeloma that involves an IMP during treatment and active monitoring.\n\nAdditional eligibility criteria for randomisation into iFIT1\u002FiFIT2\u002FiFIT3 pathways, as follows:\n\nInclusion criteria for randomisation into all iFIT1\u002FiFIT2\u002FiFIT3 pathways:\n\n* Completed 6 cycles of DRd induction therapy after registering within the iFIT study,\n* Able to provide full informed consent, and\n* Prepared to comply with pregnancy prevention plan.\n\nInclusion criteria specific to randomisation pathways:\n\n* Dexamethasone may have been stopped due to toxicity and the participant will remain eligible (iFIT1 and iFIT3),\n* Planned to continue on at least daratumumab (monthly) and lenalidomide (at any dose level) (iFIT1 and iFIT3),\n* Planned to continue on all three DRd medications (dose reductions are allowed) (iFIT2),\n* Achieved a partial response (PR) biochemically (irrespective of MRD status) or achieved a ≥VGPR and are MRD positive, as confirmed by HMDS (central laboratory) (iFIT1 and iFIT2),\n* Achieved a ≥VGPR and are MRD negative, as confirmed by HMDS (central laboratory) (iFIT3),\n* Categorised as FIT or UNFIT according to the IMWG frailty index (iFIT1),\n* Categorised as FRAIL according to the IMWG frailty index (iFIT2), and\n* Meet the blood criteria specified in the protocol within 14 days before randomisation (haematological and biochemical) (iFIT1).\n\nExclusion criteria for randomisation into all iFIT1\u002FiFIT2\u002FiFIT3 pathways:\n\n* Received systemic anti-myeloma therapy other than DRd prior to randomisation. Steroids given (by any route) for reasons other than myeloma disease control are allowed,\n* Received a stem cell transplant,\n* Participation in any other interventional study for myeloma that involves an IMP during treatment and active monitoring, and\n* Pregnant, breast feeding, plans to become pregnant, or plans to father a child whilst enrolled in the study or within a specified period after the last dose.\n\nExclusion criteria specific to randomisation pathways:\n\n* Stable disease (SD) or progressive disease (PD) as per IMWG response criteria (iFIT1 and iFIT2),\n* Partial response (PR), stable disease (SD) or progressive disease (PD) as per IMWG response criteria (iFIT3), and\n* Further exclusion criteria related to safety of interventions (iFIT1).\n\nFull inclusion and exclusion criteria are listed in the protocol.",{"count":55,"type":22},1226,[57],"PHASE3","iFIT is a trial for newly diagnosed transplant-ineligible patients with the bone marrow cancer myeloma. These patients are generally older and have a lower level of fitness than others. Patients can take part if their doctor would otherwise recommend the standard NHS treatment daratumumab, lenalidomide and dexamethasone (DRd). After six months of DRd, the subsequent treatment a patient receives in iFIT is based on two factors: the patient's fitness level and treatment response. The trial compares different treatment strategies to determine whether outcomes can be improved for specific patient groups.",[60,28],"Multiple Myeloma (MM)",[62,63,64,65,66,67],"Myeloma","Platform adaptive design","Immunotherapy","Frailty","Personalised therapy","Biomarker-driven","2026-06-09",{"date":70,"type":37},"2026-06-16",{"date":72,"type":22},"2026-06",{"date":74,"type":22},"2037-05",{"name":76,"class":44},"University of Leeds",4,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":45},"100632084","phase-2-il-15-armored-car-t-therapy-in-relapsed-or-refractory-multiple-myeloma-and-plasma-cell-leukemia-100632084","NCT07509086","IL-15-Armored CAR-T Therapy in Relapsed or Refractory Multiple Myeloma and Plasma Cell Leukemia","A Clinical Study Evaluating the Safety and Efficacy of IL-15-armored Novel CAR-T Cell Therapy in Patients With Relapsed\u002FRefractory Multiple Myeloma and Plasma Cell Leukemia","Inclusion Criteria:\n\n1. Able and willing to provide written informed consent and comply with the scheduled visits, study treatment, laboratory assessments, and other study procedures.\n2. Clinically diagnosed relapsed or refractory multiple myeloma or plasma cell leukemia (PCL). Patients with persistent minimal residual disease (MRD) positivity or conversion from MRD-negative to MRD-positive status following induction and consolidation therapy are also eligible for enrollment.\n3. Age 18 to 80 years, inclusive.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.\n5. Estimated life expectancy \\> 3 months from the date of signing the informed consent form.\n6. Hemoglobin ≥ 60 g\u002FL (transfusion permitted).\n7. Adequate organ function as defined below:\n\n   * Creatinine clearance (CrCl) ≥ 40 mL\u002Fmin, calculated using the Cockcroft-Gault formula;\n   * Left ventricular ejection fraction (LVEF) ≥ 50%;\n   * Oxygen saturation \\> 90% on room air;\n   * Total bilirubin ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN.\n8. Participants of childbearing potential must agree to use effective contraception prior to study enrollment and for at least 6 months after completion of study treatment. Participants who become pregnant or suspect pregnancy must notify the investigator immediately.\n\nExclusion Criteria:\n\n1. History within 1 year prior to signing the informed consent form of any of the following:\n\n   * New York Heart Association (NYHA) Class III or IV heart failure;\n   * Myocardial infarction;\n   * Cardiac angioplasty or stent placement;\n   * Unstable angina;\n   * Other clinically significant symptomatic cardiac disease;\n2. Active graft-versus-host disease (GVHD) or requirement for systemic immunosuppressive therapy.\n3. History of other malignancies within 5 years prior to screening, except for adequately treated carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin, localized prostate cancer after radical surgery, or ductal carcinoma in situ of the breast after curative surgery.\n4. Active infection requiring systemic therapy or uncontrolled infection within 7 days prior to screening (excluding mild genitourinary or upper respiratory tract infections).\n5. Evidence of active viral or infectious disease as follows:\n\n   * Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA above the lower limit of detection;\n   * Positive hepatitis C virus (HCV) antibody with detectable HCV RNA;\n   * Positive human immunodeficiency virus (HIV) antibody;\n   * Positive Treponema pallidum particle agglutination assay (TPPA).\n6. Participation in another clinical trial within 4 weeks prior to signing the informed consent form, or if the time from the last dose of an investigational drug to informed consent is less than 5 half-lives of that drug (whichever is longer).\n7. History of severe allergic reactions to biologic products.\n8. Any unstable systemic disease, as judged by the investigator, including but not limited to severe hepatic, renal, or metabolic disorders requiring medical treatment.\n9. Pregnant or breastfeeding women; women planning to become pregnant within 2 years after cell infusion; or male participants whose partners plan to become pregnant within 2 years after cell infusion.\n10. Any condition that, in the opinion of the investigator, may increase the participant's risk or interfere with study participation or interpretation of study results.","80 Years",{"count":87,"type":22},25,[25],"This is an open-label, single-arm, Phase 2 study to evaluate the efficacy and safety of IL-15-armored chimeric antigen receptor T-cell (CAR-T) therapy in subjects with relapsed or refractory multiple myeloma and plasma cell leukemia.",[91,28],"Relapsed\u002FRefractory Multiple Myeloma",[91,93,94],"Plasma Cell Leukemia","IL-15-armored CAR-T","RECRUITING","2026-03-28",{"date":98,"type":37},"2026-04-03",{"date":100,"type":37},"2025-12-29",{"date":102,"type":22},"2029-07-15",{"name":104,"class":44},"The First Hospital of Jilin University",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":23,"phases":115,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"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":114,"type":22},40,[116],"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.",[119,28],"Relapsed\u002FRefractory Multiple Myeloma (RRMM)","2026-01-15",{"date":122,"type":37},"2026-01-20",{"date":124,"type":22},"2026-02-15",{"date":126,"type":22},"2029-08-15",{"name":43,"class":44},{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":17,"minAge":134,"maxAge":19,"enrollmentInfo":135,"targetDuration":4,"studyType":23,"phases":137,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":45},"100599520","early-phase-1-safety-and-efficacy-of-metabolically-armed-bcma-car-t-cells-meta10-bcma-in-the-treatment-of-rr-plasma-cell-neoplasms-clinical-research-100599520","NCT07085559","Safety and Efficacy of Metabolically Armed BCMA CAR-T Cells (Meta10-BCMA) in the Treatment of r\u002Fr Plasma Cell Neoplasms Clinical Research","Inclusion Criteria:\n\n* Age 19 to 75 years old, male or female. The subject or his\u002Fher guardian voluntarily signed the informed consent;\n* Subjects with relapsed or refractory Plasma Cell Neoplasms（including Multiple Myeloma, Plasma Cell Leukemia, AL Amyloidosis）according to IMWG criteria and have had at least 3 prior lines of therapy (including chemotherapy based on proteasome inhibitors and immunomodulatory agents). Disease progression must be documented during or within 12 months following the most recent anti-myeloma treatment (for subject whose last-line treatment was CAR-T, disease progression was not limited to occurring within 12 months after treatment).\n* Evidence of cell membrane BCMA expression, as determined by a validated immunohistochemistry (IHC) or flow cytometry of tumor tissue.\n* The subjects were unable to receive autologous hematopoietic stem cell transplantation treatment, or relapsed after autologous hematopoietic stem cell transplantation, and the researchers determined that treatment was needed.\n* ECOG performance score 0-2 (except for subjects with central nervous system invasion, which needs to be confirmed by the investigator).\n* Estimated life expectancy≥12 weeks.\n* Subjects should have adequate organ function:\n\n  1. Complete blood count (CBC) test \\[the following criteria should be met within 24 hours prior to apheresis, and supportive treatment such as transfusion, platelet transfusion, cell growth factor (except recombinant erythropoietin) should be avoided within 7 days prior to detection\\]: Absolute neutrophil count (ANC) ≥1×10\\^9 \u002FL; hemoglobin ≥70 g\u002FL.; platelets ≥50×10\\^9 \u002FL; absolute lymphocyte count (ALC) ≥0.3×10\\^9 \u002FL;\n  2. Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×upper limit of normal (ULN); total serum bilirubin ≤ 1.5×ULN.\n  3. Kidney function: Serum creatinine ≤2.5×upper limit of normal (ULN), or； Creatinine clearance rate (CrCl) calculated according to Cockcroft-Gault formula ≥ 60 ml\u002Fmin.\n  4. Electrolytes: Serum potassium ≥ 3.0 mmol\u002FL; Serum calcium ≥ 2.0 mmol\u002FL; Serum magnesium ≥ 0.5 mmol\u002FL.\n  5. Coagulation function: Fibrinogen ≥ 1.0 g\u002FL; activated partial thromboplastin time (APTT) ≤ ULN+10s, prothrombin time (PT) ≤ ULN+3s.\n  6. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%.\n* The subjects must be willing to provide valid initial diagnostic evidence and undergo bone marrow examinations before and after treatment.\n* Women of childbearing age and all male patients must consent to use a effective contraception for at least 12 months after Meta10-BCMA infusion and until two consecutive PCR tests show no more CAR T cells in vivo；\n* The subjects should have measurable disease based on at least one of the following parameters:\n\n  1. The proportion of primitive naive or monoclonal plasma cells ≥ 5% by bone marrow cytology, bone marrow biopsy histology or flow cytometry;\n  2. Serum monoclonal protein (M-protein) level: M protein ≥10 g\u002FL for IgG type, M protein ≥5g\u002FL for IgA, IgD, IgM, and IgE type;\n  3. Urine M protein level ≥200 mg\u002F24 hours;\n  4. 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  5. There are measurable extramedullary plasmacytoma lesions.\n\nExclusion Criteria:\n\n* Treatment with the following therapies within the specified period:\n\n  1. Any hematopoietic stem cell transplant(HSCT) within 2 months prior to the start of infusion of Meta10-BCMA, or any immunosuppressive therapy due to graft-versus-host disease after HSCT within the screening period;\n  2. Any major surgery within 4 weeks prior to screening;\n  3. Any radiotherapy 2 weeks prior to screening;\n  4. Any intrathecal treatment within 1 week prior to the start of infusion of Meta10-BCMA;\n  5. Any live vaccination within 4 weeks prior to the start of infusion of Meta10-BCMA and\u002For plan to receive live vaccines after participation in the trial;\n  6. Any clinical trial therapy within 4 weeks prior to the start of infusion of Meta10-BCMA, or ongoing participation in other clinical trials.\n* Following disease or surgical history:\n\n  1. ≥ grade 2 arrhythmia according to NCI CTCAE 5.0 grade or QTc\\> 450 ms (male), QTc\\> 470ms (female) (QTc is calculated using Fridericia correction formula QTc = QT \u002F RR0.33) subjects with a history of Torsades de pointes ventricular tachycardia or congenital prolonged QT syndrome;\n  2. Subjects with any of the following diseases within 12 months before the screening: including but not limited to unstable angina pectoris, myocardial infarction, congestive heart failure and severe arrhythmia, coronary artery bypass grafting or peripheral artery bypass grafting surgery, cerebrovascular events (including transient ischemic attacks), etc.;\n  3. Uncontrollable and active infections during the screening period regarded by the investigators;\n  4. Subjects infected with human immunodeficiency virus (HIV);\n  5. Subjects with active hepatitis B (defined as hepatitis B surface antigen positive or hepatitis B core antibody positive, concomitant hepatitis B virus DNA level \\> 100 IU\u002Fml);\n  6. The hepatitis C virus (HCV) antibody is positive, and the peripheral blood HCV RNA is positive;\n  7. Subjects with severe electrolyte disturbance regarded by the investigators;\n  8. Subjects with a clear gastrointestinal bleeding tendency, including the following: active local ulcer lesions, and fecal occult blood (≥ ++); subjects with a history of melena and hematemesis within two months prior to screening; Subjects who may have a major gastrointestinal bleeding history;\n  9. Subjects with a history of solid organ transplantation;\n  10. Subjects with other acute, severe, or chronic medical or psychological conditions regarded by investigators as not suitable for enrollment;\n  11. Pregnant or lactating women.\n* Prohibited treatment and\u002For medication:\n\n  1. Ongoing therapy with other anti-tumor drugs, including traditional Chinese medicine;\n  2. On-going therapy with drugs that extend the QT interval (including Class Ia and III antiarrhythmic drugs);\n  3. Subjects who need to receive oxygen daily;\n  4. Long-term use of corticosteroids (except for local inhalation).\n* Others:\n\n  1. Subject with a history of psychotropic substance abuse who are unable to quit or have mental disorders;\n  2. Subjects with concomitant diseases or comorbidities that could seriously endanger the safety of the patient or affect the completion of the trial as judged by the investigators;\n  3. There are not enough unmobilized mononuclear cells available for collection for CAR-T cell production.","19 Years",{"count":136,"type":22},36,[116],"A Study of Metabolically Armed BCMA CAR-T Cells Therapy for Patients With Relapsed and\u002For Refractory Plasma Cell Neoplasms.",[60,28,140],"AL Amyloidosis (AL)",[142,143,144],"Meta10-BCMA","CAR-T Cells Therapy","r\u002Fr plasma cell neoplasms","2025-07-24",{"date":147,"type":37},"2025-07-25",{"date":149,"type":37},"2025-06-23",{"date":151,"type":22},"2027-10-15",{"name":153,"class":154},"Anhui Provincial Hospital","OTHER_GOV"]