[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"light-chain-cardiac-amyloidosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:light-chain-cardiac-amyloidosis":53},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100650255","phase-2-selinexor-daratumumab-and-dexamethasone-xdd-for-light-chain-cardiac-amyloidosis-100650255",false,"NCT07743957","Selinexor, Daratumumab, and Dexamethasone (XDd) for Light-Chain Cardiac Amyloidosis","Selinexor Combined With Daratumumab and Dexamethasone (XDd) for the Treatment of Patients With Advanced Light-Chain Cardiac Amyloidosis: A Prospective, Multicenter, Phase II Clinical Study","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Confirmed systemic light-chain amyloidosis, meeting both of the following:\n\n  1. Tissue biopsy confirms amyloid deposition, and the amyloid precursor protein is immunoglobulin light chain or heavy-light chain. Pathologic evidence includes at least one of the following: Congo red staining positive with apple-green birefringence under polarized light microscopy; Light-chain restricted expression demonstrated by immunohistochemistry, immunofluorescence, or immunoelectron microscopy, or mass spectrometry confirming the precursor protein as immunoglobulin light chain; Electron microscopy showing nonbranching, rigid, randomly arranged fibrils with a diameter of 8 to 14 nm.\n  2. Evidence of monoclonal immunoglobulin or free light chain in serum or urine, or detection of monoclonal plasma cells\u002FB cells in bone marrow examination.\n* Clinical manifestations, physical examination, laboratory tests, or imaging studies confirm involvement of one or more organs, with mandatory cardiac involvement. Cardiac involvement is defined as either:\n\n  1. Mean ventricular wall thickness \\> 12 mm on echocardiography, with other cardiac diseases excluded; or\n  2. NT-proBNP \\> 332 ng\u002FL in the absence of renal insufficiency and atrial fibrillation.\n* Mayo 2004 stage IIIa or IIIb disease, including newly diagnosed and relapsed\u002Frefractory patients.\n* Measurable disease in light-chain amyloidosis, defined by at least one of the following:\n\n  1. Serum monoclonal protein ≥ 0.5 g\u002FdL by serum protein electrophoresis and immunofixation performed by the central laboratory;\n  2. Serum free light chain ≥ 50 mg\u002FL with an abnormal kappa\u002Flambda ratio; or\n  3. Difference between involved and uninvolved free light chains (dFLC) ≥ 50 mg\u002FL. Note: Urine Bence Jones proteinuria alone is not sufficient to define measurable disease for eligibility.\n* Not pregnant or breastfeeding. Men and women of childbearing potential must agree to use appropriate contraception before treatment, during treatment, during any treatment interruption, and for 4 weeks after treatment completion.\n* Written informed consent has been signed by the participant. If the participant is unable to sign because of their medical condition, informed consent may be signed by a legal guardian or immediate family member.\n\nExclusion Criteria:\n\n* Active hepatitis B virus (HBV) infection, hepatitis C virus (HCV) infection, or other acquired or congenital immunodeficiency disorders.\n* Baseline peripheral neuropathy or neuropathic pain of grade ≥ 2 according to NCI CTCAE v4.0.\n* Major surgery within 30 days before enrollment.\n* Epilepsy requiring medication, dementia, or other psychiatric conditions that prevent understanding of or compliance with the study protocol.\n* Any severe physical or psychiatric illness that may interfere with participation in this clinical study.\n* Any other condition that the investigator considers unsuitable for enrollment.","ALL","18 Years",{"count":19,"type":20},63,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The goal of this clinical trial is to evaluate whether selinexor combined with daratumumab and dexamethasone (XDd) can treat patients with advanced light-chain cardiac amyloidosis. The main questions it aims to answer are:\n\nDoes XDd regimen achieve hematologic complete response in patients with advanced light-chain cardiac amyloidosis? Does XDd regimen improve cardiac response, organ response, progression-free survival, overall survival, quality of life, and safety?",[26],"Light-chain Cardiac Amyloidosis","NOT_YET_RECRUITING","2026-08-12",{"date":30,"type":31},"2026-08-13","ACTUAL",{"date":33,"type":20},"2026-07-13",{"date":35,"type":20},"2028-06-01",{"name":37,"class":38},"Beijing Anzhen Hospital","OTHER",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":46,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":4},"100631715","phase-1-car-nk-therapy-for-cardiac-amyloidosis-100631715","NCT07504289","CAR-NK Therapy for Cardiac Amyloidosis","Clinical Study of CAR-NK Cells Targeting BCMA\u002FCD19 in the Treatment of Refractory\u002FRelapsed Light-Chain Cardiac Amyloidosis","Inclusion Criteria：\n\n1. Voluntarily participate in this study and sign the informed consent form.\n2. Aged 18 to 75 years, of either sex.\n3. Pathologically confirmed amyloidosis, with positive Congo red staining of tissue specimens, green birefringent material observed under polarizing microscope, or characteristic electron microscopic findings.\n4. Presence of measurable light chain amyloidosis lesions meeting at least one of the following criteria:\n\n1）Serum M-protein ≥ 0.5 g\u002FdL (detected by routine serum protein electrophoresis and immunofixation electrophoresis).\n\n2）Abnormal κ\u002Fλ ratio, with the difference between involved and uninvolved free light chains (dFLC) ≥ 50 mg\u002FL.\n\n5\\. Confirmed cardiac involvement by amyloidosis, meeting at least one of the following criteria; extramyocardial organ involvement is permitted:\n\n1. Echocardiography: Mean ventricular wall thickness \\> 12 mm with no other identifiable cardiac etiologies.\n2. Elevated NT-ProBNP level (\\> 332 ng\u002FL) without concomitant renal failure or atrial fibrillation.\n\n6\\. Having received at least one course of first-line therapy based on bortezomib or CD38 monoclonal antibody with suboptimal hematological response, meeting at least one of the following criteria:\n\n1. Failure to achieve partial response (PR) after 1 treatment cycle.\n2. Failure to achieve very good partial response (VGPR) after 2 treatment cycles. 7. Estimated overall survival ≥ 12 weeks. 8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 3.\n\n9\\. Sufficient organ function reserve excluding the heart, meeting all the following criteria:\n\n1. Peripheral blood neutrophil count ≥ 1000\u002FμL, hemoglobin ≥ 7 g\u002FdL, platelet count ≥ 50,000\u002FμL; red blood cell or platelet transfusion is permitted within 1 week prior to screening.\n2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper normal limit (UNL).\n3. Serum total bilirubin ≤ 1.5 × UNL.\n4. Estimated glomerular filtration rate (eGFR) ≥ 20 mL\u002Fmin\u002F1.73 m², calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.\n5. Baseline oxygen saturation \\> 92% in a natural indoor air environment. 10. A prior history of one hematopoietic stem cell transplantation is permitted.\n\n11\\. At least 3 weeks have elapsed since the completion of approved therapeutic interventions for AL cardiac amyloidosis (e.g., systemic chemotherapy, immunotherapy) prior to the administration of the study drug.\n\n12\\. Female subjects of childbearing potential must have a negative pregnancy test and agree to adopt effective contraceptive measures during the trial period.\n\nExclusion Criteria:\n\n1. NT-ProBNP ≥ 8500 ng\u002FL;\n2. Heart failure of New York Heart Association (NYHA) functional class IIIB or IV ;\n3. Heart failure judged by the investigator to be caused by ischemic heart disease (e.g., a previous myocardial infarction with documented elevated cardiac enzymes and electrocardiographic changes) or uncorrected valvular heart disease, rather than primarily by AL amyloidosis;\n4. Hospitalization for unstable angina or myocardial infarction within 6 months prior to the first dose, or percutaneous coronary intervention with recent stent implantation within 6 months, or coronary artery bypass grafting within 6 months;\n5. For subjects with congestive heart failure, hospitalization for cardiovascular-related diseases within 4 weeks prior to screening;\n6. Baseline corrected QT interval by Fridericia's formula (QTcF) \\> 500 milliseconds on a 12-lead electrocardiogram at screening. Subjects with a permanent pacemaker implanted may be enrolled regardless of their calculated QTc interval;\n7. Supine systolic blood pressure \\\u003C 90 mmHg, or symptomatic orthostatic hypotension (defined as a decrease in systolic blood pressure \\> 20 mmHg upon standing despite pharmacotherapy (e.g., midodrine, fludrocortisone) and no hypovolemia);\n8. A history of hypersensitivity to any component of the cellular product;\n9. A history of other malignant neoplasms;\n10. Receipt of BCMA-targeted therapy, including antibody-drug conjugates (ADCs), bispecific antibodies, and cellular therapy, within 3 months prior to screening;\n11. Receipt of gene therapy within 3 months prior to screening;\n12. Active infections requiring treatment (excluding uncomplicated urinary tract infections and bacterial pharyngitis); prophylactic antibiotic, antiviral, and antifungal therapy is permitted, however;\n13. Subjects infected with hepatitis B (HBsAg-positive with HBV-DNA \\\u003C 10³ copies\u002FmL is not an exclusion criterion) or hepatitis C virus (including virus carriers), syphilis, and other acquired or congenital immunodeficiency diseases, including but not limited to human immunodeficiency virus (HIV) infection;\n14. Unresolved toxicities from prior antineoplastic therapy (toxicities per CTCAE Version 5.0 not recovered to ≤ Grade 1, except for fatigue, anorexia, and alopecia);\n15. Subjects with a history of epilepsy or other central nervous system diseases;\n16. Lactating women who are unwilling to discontinue breastfeeding;\n17. Any other condition that the investigator deems may increase the risk to the subject or interfere with the trial results.","75 Years",{"count":48,"type":20},36,[50,23],"PHASE1","Relapsed\u002Frefractory (R\u002FR) light chain cardiac amyloidosis is associated with a poor prognosis, and cellular immunotherapy constitutes a crucial therapeutic modality for these patients. The efficacy and safety of CAR-T therapy have been reported in relevant studies; however, CAR-T manufacturing requires a lengthy timeline, and the leukapheresis procedure places an additional cardiac burden on patients. CAR-NK therapy boasts superior safety profiles compared with CAR-T therapy, and natural killer (NK) cells feature a wide range of sources. Investigators have accumulated prior experience in the clinical application of CAR-NK therapy, and has also achieved the successful development and preclinical application of CD19\u002FBCMA dual-target CAR-T products. Furthermore, in the institution of the Investigator, there are dozens of newly diagnosed and more than 100 follow-up patients with AL cardiac amyloidosis each year. Investigators propose to initiate a phase I\u002FII prospective clinical study to assess the safety and efficacy of umbilical cord blood-derived BCMA\u002FCD19-targeted CAR-NK cell therapy for participants with relapsed\u002Frefractory light chain cardiac amyloidosis.",[53],"Light Chain Cardiac Amyloidosis","2026-03-25",{"date":56,"type":31},"2026-03-31",{"date":58,"type":20},"2026-03-07",{"date":60,"type":20},"2029-03-06",{"name":62,"class":38},"Second Affiliated Hospital, School of Medicine, Zhejiang University"]