[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsed-or-refractory-multiple-myeloma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsed-or-refractory-multiple-myeloma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,51,74,84,115,141,163,185,205,225,247,269,290,311,332,352,372,391,412],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100053442","phase-3-a-study-to-evaluate-mezigdomide-bortezomib-and-dexamethasone-mezivd-versus-pomalidomide-bortezomib-and-dexamethasone-pvd-in-participants-with-relapsed-or-refractory-multiple-myeloma-rrmm-100053442",false,"NCT05519085","A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)","A Phase 3, Two-Stage, Randomized, Multicenter, Open-Label Study Comparing Mezigdomide (CC-92480), Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM): SUCCESSOR-1","SUCCESSOR-1","Inclusion Criteria\n\n\\- Participant has documented diagnosis of MM and measurable disease, defined as any of the following:.\n\ni) M-protein ≥ 0.5 grams per deciliter (g\u002FdL) by serum protein electrophoresis (sPEP) or.\n\nii) M-protein ≥ 200 milligrams (mg) per 24-hour urine collection by urine protein electrophoresis (uPEP).\n\niii) For participants without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels \\> 100 mg\u002FL (10 mg\u002FdL) involved light chain and an abnormal kappa\u002Flambda FLC ratio.\n\n* Participants received 1 to 3 prior lines of antimyeloma therapy.\n* Participants achieved minimal response \\[MR\\] or better to at least 1 prior antimyeloma therapy.\n\nExclusion Criteria\n\n\\- Participant has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor, except as noted below:.\n\ni) Subjects who progressed while being treated with, or within 60 days of last dose of bortezomib maintenance given once every 2 weeks (or less frequently) are not excluded.\n\nii) Participants who progressed while being treated with ixazomib monotherapy maintenance ≥ 6 months prior to the time of starting study treatment are not excluded.\n\n* For participants with prior treatment of a bortezomib containing regimen, the best response achieved was not a minimal response (MR) or better, or participant discontinued bortezomib due to toxicity.\n* Participant has had prior treatment with mezigdomide or pomalidomide.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","ALL","18 Years",{"count":20,"type":21},810,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.",[27],"Relapsed or Refractory Multiple Myeloma",[29,30,31,32,33,34,35,36,37],"Multiple myeloma","RRMM","MeziVd","PVd","CC92480","pomalidomide","bortezomib","dexamethasone","mezigdomide","RECRUITING","2026-07-10",{"date":41,"type":42},"2026-07-13","ACTUAL",{"date":44,"type":42},"2022-09-20",{"date":46,"type":21},"2033-11-30",{"name":48,"class":49},"Celgene","INDUSTRY",266,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100510525","phase-1-a-study-evaluating-the-safety-pharmacokinetics-and-activity-of-the-combination-of-cevostamab-and-elranatamab-in-participants-with-relapsed-or-refractory-multiple-myeloma-rr-mm-100510525","NCT05927571","A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma (R\u002FR MM)","An Open-Label, Multicenter, Phase Ib Trial Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Patients With Relapsed or Refractory Multiple Myeloma","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Diagnosis of R\u002FR MM per IMWG criteria\n* For female participants of childbearing potential: agreement to remain abstinent or use contraception\n* For male participants: agreement to remain abstinent or use a condom\n\nExclusion Criteria:\n\n* Prior treatment with cevostamab or another agent targeting fragment crystallizable receptor-like 5 (FcRH5)\n* Prior treatment with elranatamab\n* Prior allogeneic stem cell transplantation (SCT)\n* Absolute plasma cell count exceeding 500 per milliliter (mL) or 5% of the peripheral blood white cells\n* Diagnosis of Waldenström macroglobulinemia or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, skin changes (POEMS) syndrome\n* Participants with known history of amyloidosis\n* History of autoimmune disease\n* History of confirmed progressive multifocal leukoencephalopathy\n* Peripheral motor polyneuropathy of prespecified grade\n* Known or suspected chronic cytomegalovirus (CMV) and\u002For Epstein-Barr virus (EBV) infection\n* Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)\n* Acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection\n* Human immunodeficiency virus (HIV) seropositivity\n* History of central nervous system (CNS) myeloma disease\n* Significant cardiovascular disease",{"count":59,"type":21},120,[61],"PHASE1","The purpose of the study is to evaluate safety and tolerability of the combination of cevostamab plus elranatamab and also determine the recommended Phase II regimen (RP2R) for the study treatment. The study consists of a safety lead-in stage, and an expansion stage.",[27],"2026-07-01",{"date":66,"type":42},"2026-07-02",{"date":68,"type":42},"2023-08-10",{"date":70,"type":21},"2027-07-31",{"name":72,"class":49},"Genentech, Inc.",14,{"id":75,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":25,"conditions":78,"keywords":79,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":80,"startDateStruct":81,"completionDateStruct":82,"leadSponsor":83,"locationsCount":50},"100479138",{"count":20,"type":21},[24],[27],[29,30,31,32,33,34,35,36,37],{"date":66,"type":42},{"date":44,"type":42},{"date":46,"type":21},{"name":48,"class":49},{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":95,"conditions":96,"keywords":97,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":114},"100645375","phase-1-a-modular-phase-iii-multicentre-study-to-evaluate-azd4045-in-participants-with-relapsed-or-refractory-multiple-myeloma-100645375","NCT07681596","A Modular, Phase I\u002FII, Multicentre Study to Evaluate AZD4045, in Participants With Relapsed or Refractory Multiple Myeloma","A Modular, Phase I\u002FII, Open-label, Multicentre Study to Evaluate the Safety, Tolerability, Cellular Kinetics, and Efficacy of AZD4045, an Allogeneic Chimeric Antigen Receptor-T Cell (CAR-T) Therapy Targeting B Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma","Inclusion Criteria:\n\n* Participant must be 18 years or older at the time of signing the informed consent form.\n* Participants must have documented diagnosis of MM according to the IMWG diagnostic criteria.\n* Participant must have one or more of the following measurable disease criteria:\n\n  * Serum M-protein level ≥ 1.0 g\u002FdL.\n  * Urine M-protein ≥ 200 mg\u002F24 h.\n  * Serum immunoglobulin free light chain ≥ 10 mg\u002FdL (100 mg\u002FL) and abnormal serum immunoglobulin kappa lambda free light chain ratio.\n* ECOG performance score of 0 to 1.\n* Participant must have screening bone marrow aspirate and\u002For archival sample adequate for clonal sequence calibration for MRD. An archival sample obtained from any time prior is acceptable.\n* Participant must have adequate organ and bone marrow function.\n* Participant must have received at least 3 prior classes of therapy, including a PI, an IMiD, and an anti-CD38 antibody\n* Participant must have documented evidence of PD by IMWG 2016 criteria based on Investigator's determination during or after the most recent line of therapy\n\nExclusion Criteria:\n\n* Participant has a history of any grade IEC-HS and\u002For history of Grade ≥ 3 CRS and\u002For Grade ≥ 2 neurotoxicities during prior CAR-T cell therapy or T cell engaging therapy.\n* Participant has ongoing toxicity from previous anti-cancer therapy that did not resolve to baseline levels or to Grade ≤ 1 with the exception of alopecia or peripheral neuropathy.\n* Participant has a known active, or prior history of CNS involvement or exhibits clinical signs of meningeal involvement of MM.\n* Participant has systemic immunoglobulin light chain amyloidosis, active plasma cell leukaemia (presence of ≥ 5% of circulating plasma cells on a conventional peripheral blood smear) at time of screening, Waldenstrom macroglobulinemia or Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin (POEMS) syndrome.\n* Participant has a history of haematologic malignancies, other than MM, regardless of remission status.\n* Participant has a history of a prior non-haematologic malignancy unless the participant has been disease-free with no evidence of recurrence for ≥ 2 years.\n* Participant has significant neurological or psychiatric condition (active or history of).\n* Participant is positive for any of the following:\n\n  1. HIV (with exceptions)\n  2. Chronic or active hepatitis B\n  3. Active hepatitis C\n* Participant has clinically significant cardiovascular disease, including but not limited to:\n\n  1. Myocardial infarction within 6 months prior to eligibility confirmation, or an unstable or uncontrolled disease\u002Fcondition related to or affecting cardiac function.\n  2. Uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities.\n  3. Congestive heart failure Class III or IV.\n  4. Impaired cardiac function (LVEF \\\u003C 45%).\n* Participant has any other significant medical condition which, in the opinion of the Investigator, places the participant at an unacceptable risk for treatment-related complications, could interfere with the successful or safe delivery of therapy, or could interfere with evaluation of study intervention or interpretation of participant safety or study results. These include but are not limited to:\n\n  1. Serious active or uncontrolled infection.\n  2. Requirement of supplemental oxygen to maintain oxygen saturation.\n  3. Active autoimmune disease or a history of autoimmune disease within 2 years.\n  4. Inflammatory bowel disease requiring treatment within the past 5 years or other clinically significant gastrointestinal condition.\n* Participant received live, attenuated vaccine within 28 days prior to eligibility confirmation\n* Participant has undergone major surgery within 28 days prior to eligibility confirmation\n* Concurrent enrolment in another clinical study (unless the study is observational, or the participant is in the follow-up period of an interventional study).\n* Participant has a known life-threatening allergy, hypersensitivity, intolerance, or a contraindication to any study intervention or their excipients.\n* Participant received any prior CAR-T or CAR-NK therapy directed at any target within 6 months prior to eligibility confirmation.\n* Participant received any prior TCE therapy directed at any target within 6 months prior to eligibility confirmation.\n* Participant received any prior BCMA-targeted treatment within 6 months prior to eligibility confirmation.\n* Participant with a history of refractoriness to the most recent BCMA-targeted treatment received as defined as PD on or within 60 days of last dose or non-responsiveness (ie, did not achieve at least minimal response) on therapy.\n* Participant received prior allogeneic stem cell transplant at any time.\n* Participant received autologous stem cell transplant within 3 months prior to eligibility confirmation.\n* Participant received radiation therapy for treatment of plasmacytoma within 14 days before eligibility confirmation.\n* Participant received prior anti-tumour therapy as follows prior to the first dose of lymphodepletion:\n\n  a) Within 7 days:\n* Immunomodulatory or cereblon E3 ligase modulatory drugs. b) Within 14 days:\n* PI therapy.\n* Monoclonal antibody treatment for MM.\n* Cytotoxic therapy.\n* Other systemic anti-myeloma therapy.\n* Radiation. c) Within 14 days or at least 5 half-lives, whichever is longer:\n* Targeted therapy, epigenetic therapy, investigational drug or used an invasive investigational medical device.",{"count":92,"type":21},101,[61,94],"PHASE2","The purpose of this study is to assess the safety, tolerability, preliminary efficacy, cellular kinetics, and other exploratory endpoints of AZD4045 as a monotherapy and in association with daratumumab and aldesleukin for the treatment of adult participants with RRMM.",[27],[29,98,30,99,100,101,102,103,104],"Relapsed or refractory multiple myeloma","Relapsed multiple myeloma","Refractory multiple myeloma","AZD4045","CAR-T","CART","Allogeneic","NOT_YET_RECRUITING","2026-06-26",{"date":66,"type":42},{"date":109,"type":21},"2026-07-09",{"date":111,"type":21},"2029-10-30",{"name":113,"class":49},"AstraZeneca",12,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":125,"conditions":126,"keywords":127,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"100601908","phase-1-a-study-of-mrna-2808-in-participants-with-relapsed-or-refractory-multiple-myeloma-100601908","NCT07116616","A Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma","A Phase 1\u002F2, Open-label, Multicenter Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma","Key Inclusion Criteria:\n\n* RRMM with prior exposure to a proteasome inhibitor, an immunomodulatory drug (IMiD), and an anti-cluster of differentiation (CD38) monoclonal antibody.\n* Measurable disease defined as at least 1 of the following:\n\n  * Serum M-protein ≥0.5 grams\u002Fdeciliter\n  * Urine M-protein ≥200 milligrams (mg)\u002F24-hour\n  * Involved free light chain (FLC) ≥100 mg\u002Fliter and an abnormal FLC ratio\n  * Plasmacytoma with a single diameter ≥2 centimeters\n  * Bone marrow plasma cells \\>30%\n\nKey Exclusion Criteria:\n\n* Known central nervous system (CNS) myeloma or clinical signs and symptoms of CNS involvement of myeloma.\n* Active plasma cell leukemia, defined as peripheral blood plasma cells ≥20%.\n* Radiotherapy or cytotoxic chemotherapy within 2 weeks prior to Day 1 (Baseline), except palliative radiotherapy of limited field is permissible within 2 weeks after discussion with the Sponsor medical monitor.\n* Antibody-based immunotherapy (monoclonal antibody, bispecific antibody, antibody drug conjugate) within 21 days prior to Day 1 (Baseline).\n* Proteasome inhibitor therapy or immunomodulatory agent within 14 days prior to Day 1 (Baseline).\n* Autologous hematopoietic cell transplant within 100 days prior to Day 1 (Baseline).\n* Allogeneic hematopoietic cell transplant within 180 days prior to Day 1 (Baseline).\n* Genetically modified adoptive autologous or allogeneic cellular therapy (for example, chimeric antigen receptor T cell, chimeric antigen receptor natural killer) within 12 weeks prior to Day 1 (Baseline).\n* Corticosteroid therapy ≥140 mg prednisone or equivalent cumulative dose within 14 days prior to Day 1 (Baseline).\n\nNote: Other inclusion and exclusion criteria may apply.",{"count":123,"type":21},166,[61,94],"The purpose of this study is to evaluate the safety and tolerability of mRNA-2808 in participants with relapsed or refractory multiple myeloma (RRMM).",[27],[128,30,129,130],"relapsed or refractory multiple myeloma","multiple myeloma","MM","2026-06-25",{"date":133,"type":42},"2026-06-29",{"date":135,"type":42},"2025-09-30",{"date":137,"type":21},"2032-06-17",{"name":139,"class":49},"ModernaTX, Inc.",10,{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":22,"phases":150,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":162},"100594331","phase-2-phase-ii-study-of-qls32015-combination-therapy-in-the-treatment-of-multiple-myeloma-100594331","NCT07018050","Phase II Study of QLS32015 Combination Therapy in the Treatment of Multiple Myeloma","A Multicenter, Open-Label Phase II Study to Evaluate QLS32015 Combination Therapy in the Treatment of Multiple Myeloma","Inclusion Criteria:\n\n* Diagnosis of multiple myeloma confirmed according to the 2016 International Myeloma Working Group (IMWG) diagnostic criteria;\n* Prior therapy: Relapsed, progressed, or intolerant to ≥1 prior line of anti-multiple myeloma therapy;\n* Measurable disease at screening, defined by at least one of the following:\n\n  * Serum M-protein ≥1.0 g\u002FdL (10 g\u002FL);\n  * Urine M-protein ≥200 mg\u002F24 hours;\n  * Serum immunoglobulin free light chain ≥10 mg\u002FdL (100 mg\u002FL) with an abnormal serum immunoglobulin κ\u002Fλ free light chain ratio.\n\nExclusion Criteria:\n\n* History of Grade 3 or higher cytokine release syndrome (CRS) associated with any T-cell redirecting therapy (e.g., CD3-redirecting technologies or CAR-T cell therapy);\n* Prior anti-myeloma therapies within the specified timeframes before enrollment:\n\n  * Previous treatment with GPRC5D-targeted therapy;\n  * Genetically modified adoptive cell therapy (e.g., chimeric antigen receptor T-cell \\[CAR-T\\], natural killer \\[NK\\] cell therapy) within 3 months;\n  * Targeted therapy, investigational drugs, or invasive investigational medical devices within 21 days or 5 half-lives (whichever is longer);\n  * Bispecific antibody therapy for multiple myeloma within 21 days or 5 half-lives (whichever is longer);\n  * Cytotoxic therapy or monoclonal antibodies within 21 days;\n  * Proteasome inhibitor therapy within 14 days;\n  * Immunomodulatory drug therapy within 7 days;\n* Radiotherapy within 14 days (except low-dose palliative radiation \\[10-30 Gy\\]);\n* Prior intolerance to Pomalidomide (applies to treatment cohorts containing Pomalidomide);\n* Prior intolerance to Bortezomib (applies to treatment cohorts containing bortezomid);\n* Prior intolerance to Lenalidomide (applies to treatment cohorts containing Lenalidomide);\n* Prior intolerance to Daratumumab (applies to treatment cohorts containing Daratumumab).",{"count":149,"type":21},160,[94],"The purpose of the study is to compare the efficacy of QLS32105 (SC) in combination with Pomalidomide, and QLS32105 (SC) in combination with QL2109 or Daratumumab, and QLS32105 (SC) in combination with QL2109 or Daratumumab and Pomalidomide, and QLS32105(SC) in combination with Bortezomib and Lenalidomide.",[27],"2026-06-05",{"date":155,"type":42},"2026-06-08",{"date":157,"type":42},"2025-09-12",{"date":159,"type":21},"2028-07",{"name":161,"class":49},"Qilu Pharmaceutical Co., Ltd.",1,{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":22,"phases":172,"briefSummary":173,"conditions":174,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":184},"100489378","phase-1-a-study-of-jnj-79635322-in-participants-with-relapsed-or-refractory-multiple-myeloma-or-previously-treated-amyloid-light-chain-al-amyloidosis-100489378","NCT05652335","A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis","Phase 1, First-in-Human, Dose Escalation Study of JNJ-79635322, a Trispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated AL Amyloidosis","Inclusion Criteria:\n\nFor participants with relapsed or refractory multiple myeloma:\n\n* Have a documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria\n* Part 1: Have relapsed or refractory disease, have been treated with a proteasome inhibitor, immunomodulatory drug (IMiD) agent, and an anti-CD38-based therapy for the treatment of multiple myeloma (MM),and should have been treated with at least 3 prior lines of therapy, or are refractory to proteosome inhibitor, IMiD agent, and an anti-CD38-based therapy regardless of prior lines of therapy, Part 2: Have relapsed or refractory disease, have been treated with a PI, IMiD and an anti-CD38 based therapy\n* Must have an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n* Have measurable disease at screening as defined by at least 1 of the following: a) Serum M-protein level greater than or equal to (\\>=) 0.5 grams per deciliter (g\u002FdL); or b) Urine M-protein level \\>=200 milligrams (mg)\u002F24 hours; or c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) \\>=10 milligrams per deciliter (mg\u002FdL) and abnormal serum Ig kappa lambda FLC ratio; d) For participants without measurable disease in the serum, urine, or involved FLC, presence of 1 or more focus of extramedullary disease (EMD) which meets the following criteria: extramedullary plasmacytoma not contiguous with a bone lesion, at least 1 lesion \\>=2 centimeter \\[cm\\] (at its greatest dimension) diameter on whole body Positron Emission Tomography and Computed Tomography (PET-CT) Scans (or whole body magnetic resonance imaging \\[MRI\\] approved by sponsor), and not previously radiated (Part 2C participants are not required to have measurable disease)\n\nFor participants with previously treated AL amyloidosis:\n\n* Initial histopathological diagnosis of amyloidosis\n* Participant who is not a candidate for available AL amyloidosis therapy with established clinical benefit and should have received at least 3 cycles of 1 prior line of therapy or a total of at least 2 cycles of 2 or more prior lines of therapy for AL amyloidosis\n* Measurable disease at screening defined by at least 1 of the following: serum involved free light chain (iFLC) \\>=50 mg\u002FL or difference between involved and uninvolved free light chains (dFLC) \\>=50 mg\u002FL, or serum m-protein \\>= 0.5 g\u002FdL\n* One or more organs impacted by systemic AL amyloidosis\n* Left ventricular ejection fraction (LVEF) \\>=45%\n\nExclusion Criteria:\n\nFor participants with relapsed or refractory multiple myeloma:\n\n* Central Nervous System (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required\n* Active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis\n* Received a cumulative dose of corticosteroids equivalent to greater than (\\>) 140 mg of prednisone within the 14-day period before the start of study treatment administration\n* Prior antitumor therapy as follows, in the specified time frame prior to the first dose of study treatment: (proteasome inhibitor \\[PI\\] therapy or radiotherapy within 14 days, immunomodulatory drug (IMiD) agent therapy within 7 days, gene-modified adoptive cell therapy within 90 days \\[not applicable for Part 2C participants\\], or CD3-redirecting therapy within 21 days\\[not applicable for Part 2B or 2C participants\\])\n* Prior allogeneic transplant within 6 months before the start of study treatment administration or autologous transplant within 12 weeks before the start of study treatment administration\n* Live, attenuated vaccine within 4 weeks before the first dose of study treatment\n* Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade less than or equal to (\\\u003C=) 1 (except alopecia, tissue post-RT fibrosis \\[any grade\\] or peripheral neuropathy to Grade \\\u003C=3)\n* The following medical conditions: pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency (HIV) infection, active hepatitis B or C infection, stroke or seizure within 6 months prior to first dose of study treatment, autoimmune disease, serious active viral or bacterial infection, uncontrolled systemic fungal infection, cardiac conditions (myocardial infarction \\\u003C=6 months prior to enrollment, New York Heart Association stage III or IV congestive heart failure, et cetera)\n* Part 2C: have progressive disease or refractory disease per IMWG after CAR-T administration\n\nFor participants with previously treated AL amyloidosis:\n\n* CNS involvement or clinical signs of meningeal involvement of AL amyloidosis. If either is suspected, whole brain MRI and lumbar cytology are required\n* Any form of non-AL amyloidosis, including but not limited to transthyretin (ATTR) amyloidosis\n* Active plasma cell leukemia, Waldenstrom's macroglobulinemia, or POEMS syndrome\n* Pulmonary compromise requiring supplemental oxygen use\n* Any serious medical conditions such as: active viral, bacterial, fungal infection; active autoimmune disease; HIV infection, active hepatitis B or C infection, stroke or seizure within 6 months prior to first dose of study treatment, significant cardiovascular conditions\n* Previous or current diagnosis of symptomatic multiple myeloma\n* Macroglossia that impairs swallowing difficulty\n* Received a cumulative dose of corticosteroids equivalent to \\> 140 mg of prednisone within the 14-day period before the start of study treatment administration\n* Prior antitumor therapy within 21 days prior to the first dose of study treatment (PI therapy or radiotherapy within 14 days, IMiD agent therapy within 7 days, gene-modified adoptive cell therapy within 90 days, or CD3-redirecting therapy within 21 days)\n* Prior allogeneic transplant within 6 months before the start of study treatment administration or autologous transplant within 12 weeks before the start of study treatment administration\n* Live, attenuated vaccine within 4 weeks before the first dose of study treatment\n* Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to \\\u003C=1 (except alopecia, tissue post-RT fibrosis \\[any grade\\] or peripheral neuropathy to Grade \\\u003C=3)",{"count":171,"type":21},180,[61],"The primary purpose of this study is to identify the recommended phase 2 dose (RP2D\\[s\\]) and schedule(s) to be safe for JNJ-79635322 in Part 1 (dose escalation), and to characterize the safety and tolerability of JNJ-79635322 at the RP2D(s) selected and in disease subgroups in Part 2 (dose expansion).",[27,175],"Previously Treated Amyloid Light-chain (AL) Amyloidosis","2026-06-04",{"date":153,"type":42},{"date":179,"type":42},"2022-11-22",{"date":181,"type":21},"2028-08-28",{"name":183,"class":49},"Janssen Research & Development, LLC",29,{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":22,"phases":194,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":201,"leadSponsor":203,"locationsCount":162},"100641005","phase-3-a-study-in-participants-with-relapsed-or-refractory-multiple-myeloma-for-ibi3003-100641005","NCT07623798","A Study in Participants With Relapsed or Refractory Multiple Myeloma for IBI3003","A Phase 3 Randomized Study Comparing IBI3003 Versus Treatment Per Investigator's Choice in Participants With Relapsed or Refractory Multiple Myeloma","Inclusion Criteria：\n\n1. Age ≥18 years.\n2. Documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria.\n3. At least one of the following measurable disease indicators:\n\n   * Serum M-protein ≥ 5 g\u002FL（For IgA and IgD subtypes, it is recommended to use quantitative immunoglobulin measurements instead of M protein）\n   * Urine M-protein ≥200 mg\u002F24h\n   * Serum free light chain (FLC) test: affected FLC level ≥100 mg\u002FL and abnormal serum FLC ratio (\\\u003C0.26 or \\>1.65)\n4. Life expectancy ≥3 months.\n5. Fertile females and sexually active fertile males must agree to use highly effective contraception (failure rate \\\u003C1% per year) during the study and for 90 days after the last dose of the investigational drug. For participants in the clinical trial, contraceptive measures must comply with local regulations regarding the use of contraceptive methods. Females and males must agree not to donate eggs (ova, oocytes) or sperm during the study and for 90 days after the last dose of the investigational drug.\n6. Willing and able to comply with the prohibitions and restrictions specified in this protocol.\n\nExclusion Criteria：\n\n1. Previous treatment with any BCMA-targeted therapy and any GPRC5D-targeted therapy. Patients who have received either BCMA-targeted or GPRC5D-targeted therapy are allowed to participate in the study.\n2. Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.\n3. Spinal cord compression that leads to limited self-care ability occurs within six months prior to informed consent or is expected to occur in the near future.\n4. Have history of primary immunodeficiency.\n5. Have history of organ transplantation.\n6. Have received allogeneic hematopoietic stem cell transplantation within 6 months before the first administration of the study drug, or have received autologous stem cell transplantation within 3 months before the first administration of the study drug.",{"count":193,"type":21},255,[24],"The purpose of this study is to evaluate how well IBI3003 works when compared with the investigator's choice regimen (DPd or PVd)",[27],"2026-05-28",{"date":199,"type":42},"2026-06-03",{"date":153,"type":21},{"date":202,"type":21},"2029-12-31",{"name":204,"class":49},"Innovent Biologics (Suzhou) Co. Ltd.",{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":22,"phases":214,"briefSummary":215,"conditions":216,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":162},"100603568","phase-3-a-study-comparing-qls32015-monotherapy-versus-pomalidomide-dexamethasone-pd-or-selinexor-dexamethasone-sd-in-participants-with-relapsed-or-refractory-multiple-myeloma-100603568","NCT07138209","A Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma","A Phase 3 Randomized Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma","Inclusion Criteria:\n\n* Age ≥18 years old, regardless of gender.\n* Subjects should be willing and able to comply with the study schedule and protocols.\n* Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria.Must have measurable disease as defined by the following: Serum M-protein greater than or equal to 0.5 g\u002FdL; OR Urine M-protein greater than or equal to 200 mg\u002F24 hours; OR Serum free light chain (FLC) assay; involved FLC level greater than or equal to 10 mg\u002FdL provided the serum FLC ratio is abnormal.\n* Received at least 3 prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory drug, and an anti-CD38 monoclonal antibody (mAb).\n\nExclusion Criteria:\n\n* Known hypersensitivity to any of the ingredients of this product.\n* Diagnosis of active plasma cell leukemia or systemic light chain amyloidosis.\n* Has any active severe mental illness, medical illness, or other symptoms\u002Fconditions that may affect treatment, compliance, or the ability to provide informed consent, as determined by the investigator.\n* Disease is considered refractory to pomalidomide and selinexor.",{"count":213,"type":21},228,[24],"The purpose of this study is to compare the safety and efficacy of QLS32015 with Pd\u002FSd for the treatment of relapsed or refractory multiple myeloma.",[27],"2026-05-20",{"date":219,"type":42},"2026-05-22",{"date":221,"type":42},"2025-11-07",{"date":223,"type":21},"2029-12",{"name":161,"class":49},{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":22,"phases":234,"briefSummary":235,"conditions":236,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":246},"100544911","phase-1-study-of-sim0500-alone-in-participants-with-relapsed-or-refractory-multiple-myeloma-100544911","NCT06375044","Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma","A Phase I First-in-human, Open-label Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0500, A Humanized GPRC5D-BCMA-CD3 Tri-specific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma","Inclusion Criteria:\n\n1. Voluntary participation and signature of informed consent form.\n2. ≥18 years of age.\n3. Have documented diagnosis of relapsed or refractory multiple myeloma according to Criteria for Response to Multiple Myeloma Treatment(IMWG)diagnostic criteria who have failed all established standard of care.\n4. Life expectancy ≥12 weeks.\n5. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.\n6. Adequate hematologic, hepatic, and renal function.\n\nExclusion Criteria:\n\n1. Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy.\n2. Active hepatitis B (HBsAg positive and HBV DNA ≥ 1×104 copies\u002FmL or ≥ 2,000 international unit \\[IU\\]\u002FmL) or hepatitis C (HCV antibody positive and HCV RNA ≥ ULN) infection; participant with HBsAg positive or detective HBV-DNA at screening should receive antiviral treatment as per local practice during the trial.\n3. Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).\n4. Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.\n5. Active known or suspected autoimmune disease. Participants with vitiligo, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur in the absence of an external trigger, type 1 diabetes mellitus (blood glucose can be controlled by insulin therapy) can be included.\n6. Current or previous other malignancy within 3 years of study entry, except basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix or breast.\n7. Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.\n8. Participants with known active infection within 14 days prior to the first SIM0500.",{"count":233,"type":21},130,[61],"This is an open-label, multicenter phase 1 clinical trial to evaluate the safety and tolerability, efficacy, and pharmacokinetics of SIM0500 in adult participants with Relapsed or Refractory Multiple Myeloma(RRMM). The trial is consisted of two parts, Part 1 (dose escalation) and Part 2 (dose optimization). In both parts, SIM0500 will be administered until disease progression, intolerable toxicity, withdraw of consent or end of trial.",[27],"2026-03-04",{"date":239,"type":42},"2026-03-06",{"date":241,"type":42},"2024-05-24",{"date":243,"type":21},"2028-12-30",{"name":245,"class":49},"Jiangsu Simcere Pharmaceutical Co., Ltd.",11,{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":254,"enrollmentInfo":255,"targetDuration":4,"studyType":22,"phases":257,"briefSummary":258,"conditions":259,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":114},"100560240","phase-1-a-study-of-ykst02-in-participants-with-relapsed-or-refractory-multiple-myeloma-100560240","NCT06574568","A Study of YKST02 in Participants With Relapsed or Refractory Multiple Myeloma","A Multicenter, Open-label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Efficacy of YKST02 in Participants With Relapsed or Refractory Multiple Myeloma","Inclusion Criteria:\n\n1. Participants or their legally acceptable representative must sign an ICF indicating that the participants understand the purpose of, and procedures required for the study and are willing to participate in the study.\n2. Diagnosis of multiple myeloma according to the IMWG criteria.\n3. Receipt of at least two prior classes of drugs either in separate regimens or as combinations. The three classes are defined as: An immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 drug.\n4. Measurable disease at screening, as defined by at least 1 of the following:\n\n   1. Serum M-protein ≥0.5 g\u002FdL;\n   2. Urinary M-protein excretion ≥200 mg\u002F24 hours;\n   3. Abnormal serum free light chain (FLC) ratio ( \\\u003C0.26 or \\>1.65) and serum immunoglobulin FLC≥10 mg\u002FdL.\n5. Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-1.\n6. An estimated survival time of more than 12 weeks.\n7. Recovery to Grade 0-1 (Graded by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0) from adverse events related to prior therapy except alopecia.\n8. Adequate hematological and organ function.\n9. Female participants of childbearing potential must have a negative serum pregnancy test at screening. Female patients who are sexually active must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment.\n10. Male participants must agree to use reliable methods of contraception (barrier methods or sexual abstinence) and avoid sperm donation throughout the study period and until 3 months after the last dose.\n\nExclusion Criteria:\n\n1. Plasma cell leukemia (\\>2.0×10\\^9\u002FL plasma cells by standard differential), Waldenstrom's Macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary light-chain amyloidosis.\n2. History of antitumor therapy as follows, before the first dose of study drug:\n\n   1. Targeted therapy with small molecule drug within 2 weeks or 5 half-lives, whichever is longer;\n   2. Targeted therapy with macromolecular drug or Immunomodulatory agent therapy within 2 weeks;\n   3. Chemotherapy within 2 weeks;\n   4. Treatment with an investigational drug within 2 weeks or 5 half-lives, whichever is shorter;\n   5. Radical\u002Fextensive radiotherapy within 4 weeks, or local palliative radiotherapy within 2 weeks, or acute toxicity induced by previous radiotherapy have not recovered to grade ≤1;\n   6. Autologous stem cell transplantation within 12 weeks;\n   7. History of organ transplant, or allogeneic stem cell transplantation within 6 months;\n   8. Prior treatment with any B cell maturation antigen (BCMA) targeted therapy;\n   9. Prior treatment with any BCMA targeted chimeric antigen receptor modified \\[CAR\\]-T cells therapy.\n3. Any active acute graft-versus-host disease (GvHD), grade 2-4 (according to Glucksberg criteria) or active chronic GvHD requiring systemic treatment within 2 weeks.\n4. Prior myelodysplastic syndrome or malignancy within 5 years, except for localized malignancies that have been adequately treated or free of the disease for ≥ 5 years, e.g., basal cell carcinoma of the skin, squamous cell carcinoma of the skin, non-muscle invasive bladder cancer, localized prostate cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast.\n5. Active central nervous system (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma, or other evidence of uncontrolled metastases to the CNS or meninges, judged by the investigator.\n6. (a) History of or current relevant CNS pathology as epilepsy, seizure, paresis, aphasia, apoplexia, severe brain injuries, cerebellar disease, organic brain syndrome, psychosis; (b) Evidence for presence of inflammatory lesions and\u002For vasculitis on cerebral MRI.\n7. History or evidence of cardiovascular disease, including:\n\n   1. Acute coronary syndromes (eg, myocardial infarction, unstable angina) within 6 months prior to enrollment;\n   2. Coronary angioplasty or stenting within 6 months prior to enrollment;\n   3. Clinically significant unstable arrhythmias (eg, atrial fibrillation), however, atrial fibrillation has been controlled for over 30 days prior to the first dose of YKST02 were allowed;\n   4. New York Heart Association (NYHA) stage III or higher congestive heart failure within 6 months prior to enrollment; Cardiac valve morphological abnormalities recorded by ECHO (≥ grade 2), note that grade 1 cardiac valve morphological abnormalities (such as mild regurgitation\u002Fstenosis) were allowed, but participants with moderate valve thickening were excluded;\n   5. Left ventricular ejection fraction (LVEF) below lower limit of the study center, or LVEF\\\u003C50% if there is no lower limit at the study center;\n   6. The Fridericia-corrected QT interval (QTcF) ≥ 470 msec (female) or ≥ 450 msec (male)；\n   7. Implantable defibrillator;\n   8. Clinically uncontrollable hypertension (i.e., SBP≥160 mm Hg and\u002For DBP≥100 mm Hg).\n8. Known allergy to monoclonal antibody drugs or exogenous immunoglobulin.\n9. Any major organ surgery or significant trauma within 4 weeks prior to the first dose of YKST02, or those requiring elective surgeries during the study, and all AEs associated with surgery or significant trauma have not recovered before the first dose of the YKST02.\n10. Regular dose of systemic corticosteroids during 4 weeks prior to initiation of study drug, or anticipated need of corticosteroids exceeding prednisone 20 mg\u002Fday or equivalent during the trial, or any other systemic immunosuppressive therapy within 4 weeks prior to study entry.\n11. Virological tests: Hepatitis B virus surface antigen (HBsAg) positive and\u002For hepatitis B core antibody (HBcAb) positive, and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) quantitative \\>ULN of the testing institution; Hepatitis C antibody (HCV-Ab) positive and hepatitis C virus-RNA (HCV-RNA) quantitative \\> ULN of the testing institution; Anti-human immunodeficiency virus (Anti-HIV) positive. Participants will be excluded from the study if any of the above criteria is met.\n12. Uncontrolled active infections requiring oral or intravenous systemic therapy, except for local treatment.\n13. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently).\n14. Pregnant or lactating women.\n15. Known mental disorder that may affect study compliance or poor compliance.\n16. Receipt of any live attenuated vaccines or live virus vaccine within 4 weeks prior to the first dose of study treatment.\n17. Other serious systemic diseases or laboratory abnormalities or other reasons that the investigator believes are not appropriate for participating the study.","75 Years",{"count":256,"type":21},70,[61],"This study aims to provide a basis for further clinical development of YKST02. YKST02 is a study medicine that targets multiple myeloma and activates the human body to fight against this disease.",[27],"2026-02-04",{"date":262,"type":42},"2026-02-05",{"date":264,"type":42},"2024-06-14",{"date":266,"type":21},"2027-06-30",{"name":268,"class":49},"Excyte Biopharma Ltd",{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":254,"enrollmentInfo":276,"targetDuration":4,"studyType":22,"phases":278,"briefSummary":279,"conditions":280,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":162},"100621382","phase-1-clinical-study-of-od-001-injection-in-the-treatment-of-relapsed-or-refractory-multiple-myeloma-100621382","NCT07369895","Clinical Study of O&D-001 Injection in the Treatment of Relapsed or Refractory Multiple Myeloma","A Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Chimeric Antigen Receptor T Cell (O&D-001) Injection Targeting BCMA and GPRC5D in the Treatment of Relapsed or Refractory Multiple Myeloma","Inclusion Criteria:\n\n1. Aged 18-75 years, inclusive, regardless of gender.\n2. Subjects voluntarily agree to participate in this study, sign the informed consent form, and are willing to complete all trial procedures.\n3. Meets the internationally accepted diagnostic criteria for multiple myeloma (IMWG Diagnostic Criteria 2016, Appendix 1).\n4. Tumor specimen (bone marrow) from the subject tests positive for BCMA or GPRC5D expression on the myeloma cell membrane via immunohistochemistry (IHC) or flow cytometry.\n5. Patients with multiple myeloma who have received at least 2 prior lines of anti-myeloma therapy, including failure of at least one proteasome inhibitor and one immunomodulatory agent; each line of therapy should have consisted of at least one complete treatment cycle, unless the best response to that therapy was documented as Progressive Disease (PD) (according to the 2016 IMWG Response Criteria, Appendix 1); must have documented PD during or within 12 months after the last line of therapy.\n6. Has measurable disease, defined as meeting at least one of the following criteria prior to apheresis: serum M-protein ≥5 g\u002FL; urine M-protein ≥200 mg\u002F24 hours; for subjects with light chain multiple myeloma not meeting the above serum or urine M-protein criteria, an abnormal serum free light chain (sFLC) ratio with involved FLC ≥100 mg\u002FL; \\>5% clonal plasma cells in bone marrow aspirate or biopsy as assessed by cytology or flow cytometry.\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.\n8. Life expectancy of at least 3 months.\n9. Major organ function is normal, defined as meeting the following criteria:\n\n   * Hemoglobin ≥8.0 g\u002FdL (No red blood cell (RBC) transfusion within 7 days prior to laboratory testing; use of recombinant human erythropoietin is allowed. For subjects who meet the inclusion criteria at screening, RBC transfusion is permitted after the first hematology test at screening to maintain hemoglobin level ≥8.0 g\u002FdL.)\n   * Platelets ≥50×10⁹\u002FL (No platelet transfusion or transfusion support within 7 days prior to laboratory testing)\n   * Absolute Neutrophil Count (ANC) ≥1.0×10⁹\u002FL (Previous use of growth factor support is allowed, but no supportive treatment within 7 days prior to laboratory testing).\n   * AST and ALT ≤3.0 × Upper Limit of Normal (ULN).\n   * Creatinine Clearance ≥40 mL\u002Fmin (Cockcroft-Gault formula).\n   * Total Bilirubin ≤1.5 × ULN.\n   * Corrected Serum Calcium ≤12.5 mg\u002FdL (≤3.1 mmol\u002FL) or Ionized Calcium ≤6.5 mg\u002FdL (≤1.6 mmol\u002FL).\n   * Fibrinogen ≥1.0 g\u002FL.\n   * Activated Partial Thromboplastin Time (aPTT) ≤1.5×ULN.\n   * Prothrombin Time (PT) ≤1.5 × ULN.\n   * Oxygen Saturation (on room air, without oxygen supplementation) ≥92%.\n   * Left Ventricular Ejection Fraction (LVEF) ≥50%.\n10. Subjects with childbearing potential must use at least one medically recognized contraceptive method (e.g., intrauterine device, oral contraceptives, or condoms) during the study treatment period (from screening to 24 months after cell infusion). Female subjects of childbearing age must have a negative serum\u002Furine HCG test within 7 days prior to cell therapy initiation and must not be lactating.\n\nExclusion Criteria:\n\n1. Prior treatment with CAR-T\u002FTCR-T\u002FTIL or other cell therapies; known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n2. Allergy or intolerance to any of the study drugs (including chemotherapy preconditioning drugs and tocilizumab) or to any component of the cell therapy product.\n3. Received systemic anti-tumor therapy within 2 weeks prior to apheresis; or monoclonal antibody therapy for multiple myeloma within 3 weeks prior to apheresis; or radiotherapy within 2 weeks prior to apheresis, unless the radiation field involved ≤5% of the bone marrow reserve, in which case the subject is eligible regardless of the end date of radiotherapy.\n4. Participated in another clinical trial within 4 weeks prior to apheresis or within 5 half-lives of the investigational drug (whichever is longer).\n5. Use of prednisone \\>10 mg\u002Fday (or equivalent dose of other corticosteroids) within 1 week prior to apheresis.\n6. Underwent major surgery within 2 weeks prior to apheresis.\n7. Presence of any uncontrolled active infection.\n8. Severe cardiac disease, including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association \\[NYHA\\] class ≥Ⅲ), or severe arrhythmia.\n9. Unstable systemic diseases as judged by the investigator, including but not limited to: uncontrolled hypertension despite medication; severe hepatic, renal, or metabolic diseases requiring pharmacological treatment; autoimmune diseases, immunodeficiency, or other conditions requiring immunosuppressive therapy.\n10. Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and have a hepatitis B virus (HBV) DNA titer above the lower limit of the normal range of the study center; subjects who are positive for hepatitis C virus (HCV) antibody and have detectable peripheral blood HCV RNA; subjects who are positive for human immunodeficiency virus (HIV) antibody; subjects with positive syphilis testing.\n11. Diagnosis of malignancies other than multiple myeloma within 5 years prior to screening (except for carcinoma in situ \\[e.g., breast, bladder, cervical carcinoma in situ\\] or basal cell carcinoma or squamous cell carcinoma of the skin that have received potentially curative treatment).\n12. Received autologous stem cell transplantation within 12 weeks prior to apheresis.\n13. Received live vaccines within 4 weeks prior to apheresis.\n14. History of central nervous system (CNS) diseases, such as seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, psychosis; known active or history of CNS involvement or clinical signs indicating meningeal\u002Fspinal meningeal involvement by multiple myeloma.\n15. Diagnosis of plasma cell leukemia.\n16. The investigator deems the subject unsuitable for participation in this clinical study due to any clinical or laboratory abnormality or other reason.",{"count":277,"type":21},18,[61],"This study is a single-center, open and dose-escalation clinical study to evaluate the safety, tolerability, PK\u002FPD characteristics and preliminary efficacy of the investigational drug O\\&D-001 injection in the treatment of relapsed or refractory multiple myeloma.",[27],"2026-01-19",{"date":283,"type":42},"2026-01-27",{"date":285,"type":42},"2025-10-28",{"date":287,"type":21},"2028-03-28",{"name":289,"class":49},"O&D BioTech Group CO., Limited",{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":22,"phases":299,"briefSummary":300,"conditions":301,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":162},"100616943","phase-2-a-study-of-f182112-in-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma-100616943","NCT07312188","A Study of F182112 in the Treatment of Patients With Relapsed or Refractory Multiple Myeloma","A Phase II Study of F182112 Combined With Different Administration Regimens in Patients With Relapsed or Refractory Multiple Myeloma","Inclusion Criteria:\n\n* Be diagnosed with multiple myeloma according to the IMWG 2016 criteria.\n* The previous treatment regimen must contain lenalidomide (lenalidomide must be used continuously for at least 2 cycles) and a proteasome inhibitor.\n* Participants whose previous treatment regimen contained pomalidomide or who were intolerant to pomalidomide cannot be enrolled.\n* Have an ECOG performance status score of 0 - 2.\n* Meet at least one of the following measurable disease indicators:\n\n  1. Serum M - protein ≥ 5 g\u002FL.\n  2. Urine M - protein ≥ 200 mg\u002F24 h.\n  3. Serum free light chain (FLC) test: Involved FLC level ≥ 100 mg\u002FL and abnormal serum free light chain ratio (\\\u003C 0.26 or \\> 1.65).\n\nExclusion Criteria:\n\n* Patients with primary light - chain amyloidosis or plasma cell leukemia .\n* Patients with symptoms of central nervous system involvement of multiple myeloma.\n* Patients with a history of other malignancies other than multiple myeloma within 3 years before the first dose.\n* Patients with active mucosal or visceral bleeding.\n* Patients who have previously received BCMA - targeted therapy.",{"count":298,"type":21},90,[94],"This is a single - arm, multi - cohort, open - label, multi - center Phase II clinical study. It aims to evaluate the efficacy and safety of F182112 combined with different administration regimens in patients with relapsed or refractory multiple myeloma.",[27],"2025-12-16",{"date":304,"type":42},"2025-12-31",{"date":306,"type":42},"2025-07-02",{"date":308,"type":21},"2028-05-20",{"name":310,"class":49},"Shandong New Time Pharmaceutical Co., LTD",{"id":312,"slug":313,"hasResults":11,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":254,"enrollmentInfo":318,"targetDuration":4,"studyType":22,"phases":319,"briefSummary":320,"conditions":321,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":162},"100509467","phase-1-yts104-cell-injection-for-the-treatment-of-relapsed-or-refractory-multiple-myeloma-100509467","NCT05913804","YTS104 Cell Injection for the Treatment of Relapsed or Refractory Multiple Myeloma","An Exploratory Clinical Study on the Safety and Efficacy of YTS104 Cell Injection in the Treatment of Relapsed or Refractory Multiple Myeloma","Inclusion Criteria:\n\n* Aged 18-75 years, gender is not limited;\n* Patients diagnosed as relapsed\u002Frefractory multiple myeloma according to the International Myeloma Working Group (IMWG 2014) criteria for multiple myeloma after at least 3 lines of treatment (including at least one proteasome inhibitor and an immunomodulator based chemotherapy regimen), and at least one complete treatment cycle per line of treatment; Documented disease progression during or within 12 months after the most recent antimyeloma therapy (not limited to 12 months after CAR-T therapy as the last line of therapy);\n* The presence of one or more measurable lesions at screening was defined as any of the following: 1) serum M-protein ≥0.5g\u002FdL (≥5g\u002FL), 2) urinary M-protein level ≥200 mg\u002F24 hours; 3) serum free light chain (sFLC) ≥100 mg\u002FL and serum κ\u002Fλ free light chain ratio abnormal (\\\u003C0.26 or \\>1.65);\n* Good organ function;\n* ECOG score ≤1;\n* The predicted survival time was ≥12 weeks;\n* Female subjects of childbearing age or male subjects with partners of women of childbearing age agreed to use effective methods of contraception throughout the trial and for 12 months after cell infusion;\n* The subjects voluntarily participated in the study, signed the informed consent form, and complied with the follow-up.\n\nExclusion Criteria:\n\n* A history of allergy to any component of the cell product;\n* Patients who had used CAR-T cell therapy or any other gene transduction or other therapeutic products within 3 months after signing the informed consent, except those with undetectable CAR-T cells or CAR-T cells below the lower limit of detection;\n* Subjects had plasma cell leukemia, Waldenström's macroglobulinaemia, POEMS syndrome, or primary light chain amyloidosis;\n* Patients with a history of any of the following cardiovascular and cerebrovascular diseases within the preceding 6 months were screened;\n\n  1. Congestive heart failure (New York Heart Association \\[NYHA\\]≥III), congenital long QT syndrome, left front half block (double bundle block), asymptomatic right bundle branch block allowed; Myocardial infarction, unstable angina pectoris, coronary angioplasty, stent implantation, coronary\u002Fperipheral artery bypass grafting;\n  2. Cerebrovascular accident (CVA) and transient ischemic attack (TIA);\n  3. Severe arrhythmias requiring treatment (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes, etc.); d: Subjects had uncontrolled hypertension (systolic blood pressure greater than 160 mmHg and\u002For diastolic blood pressure greater than 100 mmHg), a history of hypertensive crisis, or hypertensive encephalopathy;\n* Pulmonary embolism, or deep venous thrombosis of the lower extremity requiring anticoagulation, or active lung disease and\u002For pneumonia have occurred within 6 months prior to screening;\n* Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) and HBV DNA in peripheral blood were positive. Hepatitis C virus (HCV) antibody positive and HCV RNA positive; Treponema pallidum antibody was positive;\n* Patients with known systemic lupus erythematosus, co-active or uncontrolled autoimmune diseases (e.g., Crohns disease, rheumatoid arthritis, autoimmune hemolytic anemia, etc.), primary or secondary immunodeficiency (e.g., HIV infection or severe infectious diseases);\n* Patients with previous or concurrent uncured malignant tumors with unstable control, affecting the long-term survival of the subjects, excluding cured cervical carcinoma in situ, non-invasive basal cell or squamous cell skin cancer, or other malignant tumors with local prostate cancer after radical treatment, ductal carcinoma in situ after radical treatment and no recurrence for at least 5 years;\n* Patients with current or previous history of central nervous system disease, such as seizures, stroke, severe brain injury, aphasia, paralysis, dementia, Parkinson's disease, mental illness, etc.;\n* Have central nervous system (CNS) involvement or symptoms of CNS involvement (including cranial neuropathy and extensive lesions or spinal cord compression);\n* Patients had undergone previous solid-organ transplantation or allogeneic hematopoietic stem-cell transplantation (allo-HSCT) 6 months before screening or autologous stem-cell transplantation within 3 months before apheresis;\n* Patients with acute or chronic graft-versus-host disease (GVHD) at screening time;\n* The following anti-MM treatments were used at the indicated times prior to apheresis:\n\n  1. Use of any immunosuppressant or radiotherapy within 2 weeks prior to apheresis;\n  2. Received cytotoxic or proteasome inhibitors or small-molecule targeted therapy within 2 weeks of preapheresis or 3 half-lives, whichever is shorter;\n  3. Received any macromolecular therapy such as monoclonal antibodies within 4 weeks prior to anapheresis or within 3 half-lives, whichever is shorter;\n  4. Received immunomodulator within 1 week;\n* The patient had a history of live vaccination within 4 weeks before signing ICF;\n* Subjects had a history of mental illness, or substance abuse;\n* Subjects were pregnant or lactating;\n* If participating in other interventional clinical studies before apheresis, the requirements of drug washout before apheresis should be met;\n* The investigator believes that there are other factors unsuitable for inclusion or affecting participants' participation in or completion of the study.",{"count":114,"type":21},[61],"This is a single-center, single-arm, open-label phase I clinical study to determine the safety and efficacy of relapsed or refractory multiple myeloma subjects",[27],"2025-08-11",{"date":324,"type":42},"2025-08-15",{"date":326,"type":42},"2023-06-28",{"date":328,"type":21},"2025-12-30",{"name":330,"class":331},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",{"id":333,"slug":334,"hasResults":11,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":22,"phases":341,"briefSummary":342,"conditions":343,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":344,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":351},"100482728","phase-1-safety-and-efficacy-study-of-an-anti-cd38-antibody-drug-conjugate-in-relapsed-or-refractory-multiple-myeloma-100482728","NCT05565807","Safety and Efficacy Study of An Anti-CD38 Antibody Drug Conjugate in Relapsed or Refractory Multiple Myeloma","A Phase Ib\u002FIIa, Open-Label, Dose-Escalation and Extension Study to Evaluate the Safety and Efficacy of An Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With Relapsed or Refractory Multiple Myeloma","Inclusion Criteria:\n\n1. Age ≥18 years old, regardless of gender.\n2. Previously treated with at least three drugs (including PI, IMiD, and anti-CD38 antibody), and relapsed\u002Frefractory after the most recent anti-MM therapy.\n3. Diagnosis of MM according to IMWG criteria with measurable lesions, meeting at least 1 of the following criteria:\n\n   * Serum M protein ≥ 0.5g\u002FdL (≥ 5 g\u002FL); or\n   * Urine M protein ≥ 200mg\u002F24 hours; or\n   * When the serum free light chain (FLC) ratio is abnormal, the affected FLC level is ≥10mg\u002FdL (≥100 mg\u002FL) (the normal FLC ratio is 0.26 to 1.65).\n4. ECOG performance status score is 0, 1, or 2.\n5. Willing and able to comply with the study schedule and all other study protocol requirements.\n6. Women of childbearing potential (WOCBP) (infertile women are defined as sexually mature females who had undergone a hysterectomy or bilateral oophorectomy or bilateral salpingectomy or bilateral tubal ligation\u002Fclosure, or who are infertile due to a congenital or acquired condition or spontaneously menopausal for ≥ 12 months) must have a negative blood pregnancy test during the screening. Female subjects of childbearing potential and male subjects with fertility must use a highly effective method of contraception from screening to 6 months after the last treatment.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to any of the ingredients of this product.\n2. Diagnosis of active plasma cell leukemia.\n3. Diagnosis of systemic light chain amyloidosis.\n4. MM involving the central nervous system.\n5. Has POEMS syndrome.\n6. There is spinal cord compression associated with MM.\n7. Needs to take concomitant drugs with a strong inhibitory effect or a strong induction effect on CYP3A4.\n8. Had received plasma exchange therapy within 28 days before the first administration of the study drug.\n9. Had received the following anti-tumor treatments before the first administration of the study drug: monoclonal antibody or cytotoxic drug or radiotherapy within 28 days; immunoregulator, targeted therapy or epigenetic therapy or investigational medical product or invasive investigational medical device or other anti-myeloma therapy within 28 days or 5 half-lives (whichever is shorter); proteasome inhibitor or anti-tumor traditional Chinese medicine treatment or corticosteroids with a cumulative dose of more than 140 mg prednisone (or equivalent) or a single dose of more than 40 mg\u002Fday dexamethasone (or equivalent) within 14 days.\n10. Had received CAR-T therapy or allogeneic hematopoietic stem cell transplantation therapy within 6 months before the first administration of the study drug, or have a concomitant disease of active graft-versus-host disease (GvHD) at screening.\n11. Had received autologous hematopoietic stem cell transplantation within 12 weeks before the first administration of the study drug.\n12. Had undergone major surgery or eye surgery within 28 days before the first administration of the study drug.\n13. Other malignant diseases within 3 years before the first administration of the study drug.\n14. History of grade ≥3 (muscle paralysis, eyelid disease, glaucoma requiring drug control, tearing eyes), or grade ≥2 any other ocular disease (as judged by NCI-CTCAE version 5.0) at screening.\n15. Has ≥ Grade 3 neuropathy or Grade 2 neuropathy with associated pain.\n16. The toxicity caused by the previous anti-tumor treatment did not subside to ≤ grade 1.\n17. Has the following hematological test results within 7 days before the first administration of the study drug:\n\n    1. Hemoglobin \\\u003C80g\u002FL\n    2. Platelet count \\\u003C50×10\\^9\u002FL\n    3. Absolute neutrophil count \\\u003C1.0×10\\^9\u002FL\n18. Has the following blood chemistry test results within 7 days before the first administration of the study drug:\n\n    1. Estimated creatinine clearance \\\u003C30mL\u002Fmin.\n    2. AST or ALT\\>3×upper limit of normal (ULN) or serum total bilirubin\\> 1.5×ULN.\n19. Severe or uncontrolled cardiovascular and cerebrovascular diseases requiring treatment, including:\n\n    1. New York Heart Association class\\>2;\n    2. Unstable angina pectoris that cannot be controlled by drugs;\n    3. Myocardial infarction occurred within 6 months before the first administration of the study drug;\n    4. Poorly controlled arrhythmias;\n    5. 12-lead ECG QTcF\\>470msec;\n    6. Left ventricular ejection fraction \\\u003C40%;\n    7. Poorly controlled hypertension ;\n    8. Stroke, cerebrovascular accident, or transient ischemic attack occurred within 6 months before the first administration of the study drug.\n20. Meets any of the following criteria:\n\n    1. Known chronic obstructive pulmonary disease (COPD) and forced expiratory volume in 1 second (FEV1) \\\u003C50% of predicted normal;\n    2. Known moderate or severe persistent asthma, or a history of asthma within the past 2 years, or current uncontrolled asthma of any classification;\n    3. with interstitial lung disease requiring corticosteroid therapy, drug-induced interstitial lung disease, a history of radiation pneumonitis, orclinically active interstitial lung disease suggested by any current evidence before the first administration of the study drug.\n21. Has an active bacterial, viral, or fungal infection or needs for intravenous antibiotic administration (IV) within 72 hours before the first administration of the study drug.\n22. Active or uncontrolled HBV , HCV , HIV positive.\n23. Is currently pregnant or breast feeding.\n24. Has any active severe mental illness, medical illness, or other symptoms\u002Fconditions that may affect treatment, compliance, or the ability to provide informed consent, as determined by the investigator.",{"count":340,"type":21},84,[61,94],"This is a phase Ib\u002FIIa, open-label, dose-escalation, and extension study to evaluate the safety and efficacy of an anti-CD38 antibody drug conjugate (STI-6129) in patients with relapsed or refractory multiple myeloma.",[27],{"date":324,"type":42},{"date":346,"type":42},"2023-02-09",{"date":348,"type":21},"2028-02-19",{"name":350,"class":49},"Zhejiang ACEA Pharmaceutical Co. Ltd.",4,{"id":353,"slug":354,"hasResults":11,"nctId":355,"briefTitle":356,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":358,"targetDuration":4,"studyType":360,"phases":4,"briefSummary":361,"conditions":362,"keywords":4,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":4},"100579557","long-term-follow-up-observational-study-in-patients-treated-with-gene-modified-t-cell-therapy-100579557","NCT06825845","Long Term Follow-up Observational Study in Patients Treated with Gene-Modified T-Cell Therapy","Inclusion Criteria:\n\n\\- 1. All patients who have received at least one GM T-cell infusion in the parent clinical study or in the post-approval setting.\n\n2\\. Patients must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. For patients incapable of providing consent, the signed ICF of their legally accepted guardians must be obtained.\n\nExclusion Criteria:\n\n* There are no specific exclusion criteria for this study.",{"count":359,"type":21},1500,"OBSERVATIONAL","This is a prospective long-term follow-up (LTFU) study to evaluate the long-term safety and survival benefit for patients who received at least one of CARsgen's GM T cell product in a clinical trial or as a commercially available product. In this study, patients will be followed for up to 15 years after last GM T-cell infusion for the evaluation of delayed adverse events (AEs), vector persistence, potential risk for integration, and survival time due to GM T-cell exposure.",[27],"2025-02-08",{"date":365,"type":42},"2025-02-13",{"date":367,"type":21},"2025-03-31",{"date":369,"type":21},"2040-06-30",{"name":371,"class":49},"CARsgen Therapeutics Co., Ltd.",{"id":373,"slug":374,"hasResults":11,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":4,"eligibilityCriteria":378,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":22,"phases":380,"briefSummary":381,"conditions":382,"keywords":4,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":162},"100554547","phase-1-a-study-of-qls4131-in-patients-with-recurrent-or-refractory-multiple-myeloma-100554547","NCT06500507","A Study of QLS4131 in Patients With Recurrent or Refractory Multiple Myeloma","Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Effectiveness of QLS4131 Injection in Patients With Relapsed or Refractory Multiple Myeloma","Inclusion Criteria:\n\n1. Age ≥18 years old, regardless of gender.\n2. Subjects should be willing and able to comply with the study schedule and protocols.\n3. Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria.\n4. Must have measurable disease as defined by the following: Serum M-protein greater than or equal to 1 g\u002FdL; OR Urine M-protein greater than or equal to 200 mg\u002F24 hours; OR Serum free light chain (FLC) assay; involved FLC level greater than or equal to 10 mg\u002FdL provided the serum FLC ratio is abnormal.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to any of the ingredients of this product.\n2. Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.\n3. Has any active severe mental illness, medical illness, or other symptoms\u002Fconditions that may affect treatment, compliance, or the ability to provide informed consent, as determined by the investigator.",{"count":298,"type":21},[61],"The purpose of this study is to characterize the safety of QLS4131 injection and to determine the recommended Phase 2 dose (RP2D) and to further evaluate the efficacy and safety of QLS4131 injection in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose.",[27],"2024-07-08",{"date":385,"type":42},"2024-07-15",{"date":387,"type":21},"2024-08-30",{"date":389,"type":21},"2027-01-31",{"name":161,"class":49},{"id":392,"slug":393,"hasResults":11,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":4,"eligibilityCriteria":397,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":398,"targetDuration":4,"studyType":22,"phases":400,"briefSummary":401,"conditions":402,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":162},"100533920","phase-1-a-study-of-mbs314-in-participants-with-relapsedrefractory-multiple-myeloma-100533920","NCT06232096","A Study of MBS314 in Participants With Relapsed\u002FRefractory Multiple Myeloma.","A Phase Ⅰ\u002FⅡ Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of MBS314 Injection in Patients With Relapsed\u002FRefractory Multiple Myeloma.","Inclusion Criteria:\n\n1. Able and willing to provide written informed consent and to comply with the study protocol;\n2. ≥18 years of age;\n3. Documented diagnosis of multiple myeloma according to 2014 IMWG diagnostic criteria.\n4. Phase Ⅰb\u002FⅡ: At least one measurable disease: Serum monoclonal paraprotein (M-protein) ≥5 g\u002FL or Urine M-protein ≥200 mg\u002F24 hours or Serum immunoglobulin free-light chains (FLCs) ≥100 mg\u002FL and abnormal kappa\u002Flambda FLC ratio (\\\u003C0.26 or \\>1.65)\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.\n6. Life expectancy ≥3 months.\n7. Adequate hematologic, hepatic, and renal function.\n\nExclusion Criteria:\n\n1. Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.\n2. Participants with known active infection within 14 days prior to the first MBS314.\n3. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C (including HBsAg, HBcAb positive with abnormal hepatitis B virus DNA or hepatitis C virus RNA).\n4. Previously received anti-myeloma treatment within the specified time frame prior to the first administration.\n5. Live, attenuated vaccines within 28 days prior to the first infusion of MBS314, or expected to receive live, attenuated vaccines during the study period.\n6. Major surgery within 28 days prior to the first infusion of MBS314, or expected to undergo major surgery during the study treatment.\n7. Participants with a history of autoimmune diseases.\n8. Known severe allergic reactions to other antibodies, or known allergies or hypersensitivity to any components of MBS314.",{"count":399,"type":21},154,[61,94],"This is a Phase I\u002FⅡ, multicenter, open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics(PD) and efficacy of a novel asymmetric trivalent tri-specific humanized antibody, MBS314, administered by intravenous (IV) infusion in participants with relapsed or refractory multiple myeloma. This entry-to-human study is divided in 2 parts: a dose escalation part (Phase Ⅰa) and an expansion part (Phase Ⅰb\u002FⅡ).",[27],"2024-03-14",{"date":405,"type":42},"2024-03-15",{"date":407,"type":42},"2024-02-22",{"date":409,"type":21},"2028-03",{"name":411,"class":49},"Beijing Mabworks Biotech Co., Ltd.",{"id":413,"slug":414,"hasResults":11,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":254,"enrollmentInfo":419,"targetDuration":4,"studyType":22,"phases":421,"briefSummary":423,"conditions":424,"keywords":425,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":162},"100539009","early-phase-1-to-assess-safety-tolerability-and-efficacy-of-anti-gprc5d-cd19-car-t-in-relapsedrefractory-multiple-myeloma-100539009","NCT06298266","To Assess Safety, Tolerability, and Efficacy of Anti-GPRC5D-CD19-CAR-T in Relapsed\u002FRefractory Multiple Myeloma","Clinical Study to Evaluate the Safety, Tolerability and Initial Efficacy of Anti-GPRC5D-CD19-CAR-T in Patients With Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n* 1\\. The patient or their legal guardian understands and voluntarily signs the informed consent form and is expected to complete the follow-up examinations and treatments.\n\n  2\\. Age between 18-75 years, regardless of gender. 3. Diagnosed with multiple myeloma according to the IMWG diagnostic criteria, and GPRC5D expression in bone marrow is positive (\\>10%).\n\n  4\\. Has failed treatment with at least three different mechanisms of drugs (including chemotherapy, proteasome inhibitors, immune modulators, etc.), or has experienced disease progression or relapse within 6 months after the last treatment.\n\n  5\\. Measurable lesions are present based on any of the following criteria during screening: (1) Serum monoclonal immunoglobulin (M-protein) level ≥1.0 g\u002FdL; (2) Urine M-protein level ≥200 mg\u002F24 hours; (3) Diagnosed with light chain multiple myeloma with no measurable lesions in serum or urine: Serum free light chain ≥10 mg\u002FdL and abnormal serum free light chain κ\u002Fγ ratio.\n\n  6\\. The patient has recovered from toxicities associated with previous treatment, i.e., CTCAE toxicity grade \\\u003C2 (unless the abnormality is related to the tumor or stable, with no significant impact on safety or efficacy as determined by the investigator).\n\n  7\\. ECOG performance status of 0-2 and an expected survival of more than 3 months.\n\n  8\\. Adequate organ function:\n* Alanine transaminase (ALT) ≤3 times the upper limit of normal (ULN);\n* Aspartate transaminase (AST) ≤3 times ULN;\n* Total bilirubin ≤1.5 times ULN;\n* Serum creatinine ≤1.5 times ULN, or creatinine clearance ≥60 mL\u002Fmin;\n* Indoor oxygen saturation ≥92%;\n* Left ventricular ejection fraction (LVEF) ≥45%, confirmed by echocardiography with no clinically significant pericardial effusion or clinically significant electrocardiogram findings;\n* No clinically significant pleural effusion. 9. Able to establish the required venous access for sample collection, with no contraindications for white blood cell collection.\n\nExclusion Criteria:\n\n* 1\\. Diagnosed with or treated for invasive malignant tumors other than multiple myeloma.\n\n  2\\. Previously received anti-tumor treatments including targeted therapy, epigenetic therapy, experimental drug therapy, or invasive experimental medical devices within 14 days or at least 5 half-lives (whichever is shorter) before the collection and preparation of CAR-T cells. Also, received monoclonal antibody therapy for relapsed\u002Frefractory multiple myeloma within 21 days, received cytotoxic therapy within 14 days, received proteasome inhibitor therapy within 14 days, received immunomodulatory agent therapy within 7 days, or received radiation therapy within 14 days (except for bone marrow reserves with field coverage ≤5%).\n\n  3\\. Suspected involvement of multiple myeloma in the central nervous system or meninges confirmed by MRI or CT, or presence of other active central nervous system diseases.\n\n  4\\. Screening criteria include plasma cell leukemia (according to standard classification, plasma cells \\>2.0×109\u002FL), Waldenstrom macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or secondary AL amyloidosis.\n\n  5\\. Positive for hepatitis B surface antigen (HBsAg) and positive for HBV-DNA; positive for hepatitis C virus (HCV) antibody; positive for human immunodeficiency virus (HIV) antibody; cytomegalovirus (CMV) DNA test result ≥500 copies\u002FmL; positive for syphilis test.\n\n  6\\. Positive for hepatitis C virus (HCV) antibody; positive for human immunodeficiency virus (HIV) antibody; cytomegalovirus (CMV) DNA test result ≥500 copies\u002FmL; positive for syphilis test.\n\n  7\\. History of severe allergies defined as grade II or above reactions, with clinical manifestations including airway obstruction (runny nose, coughing, wheezing, difficulty breathing), tachycardia, hypotension, arrhythmia, gastrointestinal symptoms (nausea, vomiting), urinary or fecal incontinence, laryngeal edema, bronchospasm, cyanosis, shock, respiratory or cardiac arrest, or known allergy to any active ingredient, excipient, murine-derived product, or xenogeneic protein contained in this trial (including the CleenRx regimen).\n\n  8\\. Severe cardiac diseases including but not limited to severe arrhythmias, unstable angina pectoris, extensive myocardial infarction, New York Heart Association Class III or IV heart failure, myocardial infarction within 6 months before screening or coronary artery bypass graft (CABG), unexplained history of syncope unrelated to vasovagal or dehydration, severe non-ischemic cardiomyopathy, or uncontrolled hypertension (defined as failure to achieve blood pressure goals despite using ≥3 antihypertensive drugs, including diuretics, for ≥1 month or effective blood pressure control requiring ≥4 antihypertensive drugs).\n\n  9\\. Unstable systemic diseases, including but not limited to severe liver, kidney, or metabolic diseases requiring medication.\n\n  10\\. Acute\u002Fchronic graft-versus-host disease (GVHD) within 6 months before screening or patients requiring immunosuppressive therapy for GVHD.\n\n  11\\. Active autoimmune or inflammatory diseases of the nervous system (e.g., Guillain-Barré syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically significant active cerebrovascular diseases (e.g., cerebral edema, posterior reversible encephalopathy syndrome (PRES)).\n\n  12\\. Presence of tumor emergencies (e.g., spinal cord compression, intestinal obstruction, leukostasis, tumor lysis syndrome) requiring urgent treatment during screening or before cell infusion.\n\n  13\\. Uncontrolled bacterial, fungal, viral, or other infections requiring antibiotic treatment.\n\n  14\\. Underwent major surgery (excluding diagnostic surgery and biopsies) within 4 weeks before CleenRx or planned major surgery during the study, or incomplete healing of surgical wounds before enrollment.\n\n  15\\. Received (attenuated) live virus vaccines within 4 weeks before screening. 16. Presence of severe mental disorders. 17. Alcohol or substance abuse history. 18. Pregnant or breastfeeding women, and female subjects or male subjects with partners planning pregnancy within 2 years after cell infusion, and subjects who plan to become pregnant within 2 years after cell infusion. Additionally, according to the investigator's judgment and\u002For clinical criteria, patients with contraindications to any study procedures or other medical conditions that may expose them to unacceptable risks.",{"count":420,"type":21},15,[422],"EARLY_PHASE1","To evaluate the safety and tolerability of anti-GPRC5D-CD19 CAR-T cells infusion in subjects with relapsed and refractory multiple myeloma",[27],[426,29],"GPRC5D-CD19 CART","2024-03-05",{"date":429,"type":42},"2024-03-07",{"date":431,"type":21},"2024-03-29",{"date":433,"type":21},"2026-12-31",{"name":435,"class":331},"Guangdong Second Provincial General Hospital"]