[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"systemic-light-chain-amyloidosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:systemic-light-chain-amyloidosis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,75,99],{"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":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100640019","early-phase-1-autologous-bcma-targeted-car-t-cell-injection-for-relapsedrefractory-light-chain-amyloidosis-100640019",false,"NCT07626476","Autologous BCMA-targeted CAR-T Cell Injection for Relapsed\u002FRefractory Light Chain Amyloidosis","An Exploratory Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Autologous BCMA-targeted CAR-T Cell Injection in Participants With Relapsed\u002FRefractory Light Chain Amyloidosis","Inclusion Criteria:\n\n* The participant must personally sign an ethics-committee-approved informed consent form before study start.\n* Age ≥18 years.\n* Pathologically confirmed light chain amyloidosis.\n* Relapsed\u002Frefractory light chain amyloidosis previously treated with 2 or more lines of therapy.\n* dFLC \\>50 mg\u002FL.\n* Expected survival ≥12 weeks.\n* ECOG score ≤2.\n* Diagnosis of AL amyloidosis must meet the following conditions: (1) clinical manifestations, physical examination, laboratory or imaging examinations confirm tissue or organ involvement; (2) tissue biopsy pathology confirms amyloid deposition, and the precursor protein of amyloid protein is immunoglobulin light chain or heavy and light chain; and the participant is relapsed\u002Frefractory.\n* Female participants of childbearing potential should agree to use effective contraception from the date of signing informed consent until 365 days after infusion. Effective contraception is defined as abstinence or contraception using methods specified in the protocol with an annual failure rate \\\u003C1%.\n* Adequate organ function before enrollment, meeting all of the following:\n\n  * Absolute neutrophil count ≥1.0×10\\^9\u002FL; granulocyte colony-stimulating factor (G-CSF) support is permitted.\n  * Platelet count ≥50×10\\^9\u002FL.\n  * Hemoglobin ≥8 g\u002FdL.\n  * Bilirubin ≤1.5×upper limit of normal (ULN), except biliary obstruction caused by tumor compression.\n  * ALT or AST ≤2.5×ULN; for participants with liver involvement, ≤5×ULN.\n  * Mayo 2004 stage I-IIIa.\n  * Stable coagulation function: INR ≤1.5 and APTT ≤1.2×ULN, except tumor-related anticoagulant therapy.\n  * Baseline oxygen saturation on room air \\>92%.\n\nExclusion Criteria:\n\n* Participants who have received the following prior treatments:\n\n  * Prior gene therapy before enrollment.\n  * Live vaccine injection within 4 weeks before enrollment.\n  * Other interventional clinical study drug treatment within 12 weeks before leukapheresis.\n* Central nervous system involvement or complete intestinal obstruction.\n* Moderate or higher pleural effusion or ascites that is difficult to control with conventional treatment and requires continuous catheter drainage.\n* Active malignancy within the past 5 years, unless it is a curable tumor and has been clearly cured.\n* HBsAg positivity with abnormal peripheral blood HBV DNA testing; HCV antibody positivity with peripheral blood HCV RNA positivity; HIV antibody positivity; CMV DNA positivity; or positive syphilis RPR test.\n* Uncontrolled active infection, except CTCAE grade \\\u003C2 urogenital infection and upper respiratory tract infection.\n* Severe heart disease, including but not limited to unstable angina, myocardial infarction within 6 months before screening, congestive heart failure (New York Heart Association \\[NYHA\\] class ≥III), positive six-minute walk test, interventricular septum and left ventricular posterior wall thickness \\>1.5 cm, or ventricular arrhythmia and atrioventricular block indicated by ambulatory electrocardiography.\n* Hypertension that cannot be controlled by medication.\n* Toxicity from prior treatment not recovered to baseline or ≤grade 1 according to NCI CTCAE v5.0, except alopecia and clinically insignificant laboratory abnormalities.\n* Major surgery within 2 weeks before enrollment, or planned surgery during the waiting period before infusion or within 12 weeks after study treatment, except planned local anesthesia surgery.\n* Solid organ transplantation.\n* Pregnant or breastfeeding women.\n* History of central nervous system disease, such as cerebral aneurysm, epilepsy, stroke, senile dementia or psychiatric disease, or disturbance of consciousness.\n* Other systemic disease judged unstable by the investigator, including but not limited to severe hepatic, renal or metabolic disease requiring medication.\n* Known life-threatening allergic reaction, hypersensitivity or intolerance to the CAR-T cell product or its components.\n* Bleeding or severe thrombosis as judged by the investigator, hereditary\u002Facquired bleeding or severe thrombosis, including hemophilia, coagulopathy, thrombocytopenia and hypersplenism, or current thrombolytic or anticoagulant therapy.\n* Other conditions that the investigator considers unsuitable for enrollment.","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","Systemic light chain amyloidosis (AL amyloidosis) is the most common type of systemic amyloidosis, with diverse clinical manifestations and difficulties in diagnosis and treatment. AL amyloidosis may involve multiple organs; the kidney and heart are the most commonly involved organs. The treatment goal is to reduce monoclonal immunoglobulin light-chain levels, prevent further amyloid deposition in important organs, and alleviate or reverse organ dysfunction caused by amyloid deposition. The principal approach to achieve this goal is to eliminate the plasma-cell or B-cell clones producing abnormal light chains. For patients with relapsed\u002Frefractory AL amyloidosis, the protocol states that there is currently no suitable treatment method and that participation in clinical trials is recommended.\n\nThis study evaluates targeted BCMA autologous CART cell injection in participants with relapsed\u002Frefractory light chain amyloidosis. The main purpose is to evaluate safety, preliminarily verify efficacy, and explore in vivo pharmacokinetics, pharmacodynamics, immunogenicity and related characteristics after infusion.",[26,27,28],"Relapsed\u002FRefractory Light Chain Amyloidosis","AL Amyloidosis","Systemic Light Chain Amyloidosis",[30,31,32,33,34,35],"AL amyloidosis","light chain amyloidosis","relapsed\u002Frefractory","BCMA","CAR-T","autologous CAR-T","RECRUITING","2026-05-29",{"date":39,"type":40},"2026-06-04","ACTUAL",{"date":42,"type":40},"2024-12-16",{"date":44,"type":20},"2029-12-15",{"name":46,"class":47},"Beijing Boren Hospital","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100613402","phase-1-assessment-of-the-efficacy-and-safety-of-injectable-tqb2934-subcutaneous-injection-in-systemic-light-chain-amyloidosis-patients-100613402","NCT07266116","Assessment of the Efficacy and Safety of Injectable TQB2934 (Subcutaneous Injection) in Systemic Light Chain Amyloidosis Patients","A Phase Ib\u002FII Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TQB2934 for Injection in Subjects With Systemic Light Chain Amyloidosis","Inclusion Criteria:\n\n* The subjects voluntarily joined this study, signed the informed consent form, and exhibited good compliance;\n* Aged 18 to 80 years old, with an Eastern Cooperative Oncology Group (ECOG) score of 0 to 2, and an expected survival of more than 12 weeks;\n* Systemic light chain amyloidosis with diagnostic records (i.e., primary light chain amyloidosis);\n* Presence of measurable lesions;\n* At least one organ involved;\n* Have previously received at least one line of systemic treatment, and recurred and progressed after the remission of the last line treatment;\n* N-terminal pro-B-type natriuretic peptide (NT-proBNP) ≤ 8500 ng\u002FL;\n* The corresponding organ function conforms to the protocol requirements;\n* Women of childbearing age should agree to use contraception during the study period and for 6 months after its completion; they must have a negative serum pregnancy test within 7 days before enrollment in the study and must be non-lactating subjects; men should agree to use contraception during the study period and for 6 months after its completion.\n\nExclusion Criteria:\n\n* Diagnosed with other types of amyloidosis, active plasma cell leukemia, active multiple myeloma, etc.\n* Have received allogeneic hematopoietic stem cell transplantation within 1 year prior to the first dose, or have received autologous hematopoietic stem cell transplantation within 12 weeks prior to the first dose;\n* Previously received treatment with drugs targeting the same target;\n* Within 4 weeks prior to the first dose, the patient has received a cumulative dose of dexamethasone \\>160 mg or an equivalent dose of other glucocorticoids, or within 3 weeks prior to the first dose, the patient has received targeted therapy, cytotoxic drugs, or any antibody therapy, or within 2 weeks prior to the first dose, the patient has received proteasome inhibitor therapy or radiotherapy, or within 1 week prior to the first dose, the patient has received immunomodulator therapy;\n* Those who have received treatment with traditional Chinese patent medicines and simple preparations with clear anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions within 2 weeks before the first administration;\n* Those who have received attenuated live vaccine within 4 weeks before the first dose or plan to receive attenuated live vaccine during the study period;\n* Individuals with a history of severe allergies of unknown cause, or known allergies to monoclonal antibody drugs or exogenous human immunoglobulins, or known allergies to the excipients in injectable TQB2934 or pharmaceutical preparations;\n* Having had or currently suffering from other malignant tumors within 3 years before the first medication;\n* Unresolved toxic reactions above Common Terminology Criteria (CTC) AE Grade 1 caused by any previous treatment;\n* Those who have undergone major surgical treatment, significant traumatic injury, or are expected to undergo major surgery during the study treatment period within 4 weeks before the first dose of medication;\n* Arterial\u002Fvenous thromboembolic events occurred within 6 months before the first dose;\n* Individuals with a history of abuse of psychotropic drugs who are unable to quit or who have mental disorders; or intractable seizures that require treatment;\n* Those with unsatisfactory blood pressure control;\n* Patients with poorly controlled diabetes;\n* Patients who have active or uncontrolled severe bacterial, viral, or systemic fungal infections (≥CTC AE Grade 2 infections) within 4 weeks before the first dose of medication;\n* Patients with hepatitis or decompensated liver cirrhosis (Child-Pugh Class B or C);\n* Individuals with active tuberculosis, history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radiation pneumonia requiring treatment, or clinically symptomatic active pneumonia;\n* Those who have experienced asthma within 2 years before the first medication or currently suffer from asthma or chronic obstructive pulmonary disease;\n* Individuals with significant cardiovascular diseases;\n* Individuals with a history of immune deficiency, or active autoimmune diseases requiring systemic immunosuppressive therapy, etc.\n* Exclude subjects with organ failure unrelated to systemic light-chain (AL) amyloidosis;\n* Subjects deemed unsuitable for enrollment by the researchers.","80 Years",{"count":58,"type":20},70,[60,61],"PHASE1","PHASE2","This study is a clinical trial aimed at the marketing of TQB2934 for injection. The project plans to enroll 70 subjects, including 13-21 subjects in Phase Ib, to evaluate the safety and preliminary efficacy, pharmacokinetic (PK) characteristics, immunogenicity, and pharmacodynamic (PD) of TQB2934 for injection in subjects with systemic light chain amyloidosis, and to determine the recommended Phase II dose (RP2D). The Phase II plan involves enrolling 49 subjects, aiming to demonstrate that in adult subjects with relapsed\u002Frefractory systemic light chain amyloidosis who have previously received treatment with daratumumab and bortezomib, TQB2934 for injection significantly improves the hematological complete response (CR) rate compared to historical controls. The primary endpoint is the optimal hematological CR rate.",[28],"2026-05-07",{"date":66,"type":40},"2026-05-08",{"date":68,"type":40},"2025-12-26",{"date":70,"type":20},"2029-11",{"name":72,"class":73},"Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.","INDUSTRY",27,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":48},"100604605","phase-2-bcmacd3-bispecific-antibody-treatment-for-newly-diagnosed-amyloidosis-100604605","NCT07151690","BCMA\u002FCD3 Bispecific Antibody Treatment for Newly Diagnosed Amyloidosis","A Single-arm Single-center Trial of BCMA\u002FCD3 Bispecific Antibody Treatment for Newly Diagnosed Amyloidosis","1. The patient is informed of and voluntarily signs the informed consent form (ICF).\n2. Age ≥18 years, regardless of sex.\n3. Confirmed diagnosis of primary light-chain (AL) amyloidosis, in accordance with the Guidelines for the Diagnosis and Treatment of Systemic Light-chain Amyloidosis (2021 Revision).\n4. Measurable disease at screening, defined as:\n\n   * Difference between involved and uninvolved free light chains (dFLC) ≥50 mg\u002FL, or\n   * Serum involved free light chain ≥50 mg\u002FL with an abnormal κ:λ ratio.\n5. ECOG performance status ≤2.\n6. Adequate organ function within 3 days prior to the first dose of the investigational drug, meeting all of the following criteria:\n\n   i. Absolute neutrophil count (ANC) ≥1.0 × 10⁹\u002FL, with no granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) administration within 7 days, and no pegylated G-CSF administration within 14 days prior to testing; ii. Hemoglobin (Hb) ≥75 g\u002FL, with no whole blood or red blood cell transfusion within 7 days prior to testing; iii. Platelet count ≥70 × 10⁹\u002FL, with no whole blood transfusion, platelet transfusion, or thrombopoietin receptor agonist treatment within 7 days prior to testing; iv. Hepatic function: alanine aminotransferase (ALT) ≤3 × upper limit of normal (ULN), aspartate aminotransferase (AST) ≤3 × ULN, total bilirubin ≤2 × ULN (subjects with Gilbert's syndrome are eligible if direct bilirubin ≤2 × ULN); v. Coagulation: international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤1.5 × ULN; vi. Renal function: estimated glomerular filtration rate (eGFR) ≥20 mL\u002Fmin\u002F1.73 m², calculated using the CKD-EPI equation.\n7. Male and female patients of childbearing potential, and their partners, must agree to use effective contraceptive methods deemed appropriate by the investigator throughout the treatment period and for at least 3 months thereafter.\n8. Male patients must agree not to donate sperm from the screening period until 90 days after the last dose of the investigational drug.\n9. The patient must be willing and able to comply with all study procedures and follow-up visits.\n10. Women not of childbearing potential are eligible for enrollment. Women of childbearing potential must have a negative serum or urine β-hCG pregnancy test at screening.\n\nNote:\n\nA woman of childbearing potential is defined as a sexually mature woman who has not undergone surgical sterilization (e.g., hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) and has not been postmenopausal for at least 12 consecutive months for reasons other than medical treatment. Women using oral contraceptives or intrauterine devices are considered of childbearing potential. Male subjects (including those who have undergone vasectomy) must agree to use condoms during sexual intercourse with women of childbearing potential and must have no plans to father a child from the time of signing the ICF until 3 months after the last dose of study treatment.",{"count":83,"type":20},21,[61],"This is a prospective, single-arm, single-center clinical study designed to evaluate the efficacy and safety of low-dose BCMA\u002FCD3 bispecific antibody (CM336) in patients newly diagnosed with systemic light chain (AL) amyloidosis.",[28],[28,88,89],"BCMA\u002FCD3 bispecific antibody","CM336","2026-03-19",{"date":92,"type":40},"2026-03-24",{"date":94,"type":40},"2025-09-04",{"date":96,"type":20},"2027-12-01",{"name":98,"class":47},"Institute of Hematology & Blood Diseases Hospital, China",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":107,"sex":16,"minAge":17,"maxAge":56,"enrollmentInfo":108,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":48},"100577806","the-impact-of-systemic-light-chain-amyloidosis-on-eyes-100577806","NCT06803082","The Impact of Systemic Light Chain Amyloidosis on Eyes","The Impact of Systemic Light Chain Amyloidosis on Eyes and Its Appendages","Amyloidosis","Case Group\n\nInclusion Criteria:\n\n1. Patients diagnosed with \"Systemic Light Chain Amyloidosis\";\n2. No other severe systemic underlying diseases that affect the examination;\n3. Subjects voluntarily participate in this study, sign the informed consent form;\n4. Age between 18-80 years old, no gender restrictions.\n\nExclusion Criteria:\n\n1. Patients with eye diseases of clear causes such as ocular surface malignant tumors, corneal perforation, severe eye trauma, etc.;\n2. Patients with nystagmus;\n3. Severe ocular scar diseases; conjunctival scars with fornix shortening;\n4. Current signs of infection, including fever and undergoing antibiotic treatment;\n5. Mental abnormalities;\n6. Pregnant or breastfeeding women, or women planning to become pregnant within 2 years;\n7. NYHA Class IV: Heart disease patients cannot engage in any physical activity, with heart failure symptoms even at rest, and worsening with physical activity;\n8. NT-proBNP \\> 8,500 ng\u002FL.\n\nControl Group\n\nInclusion Criteria:\n\n1. Stable general condition, not patients with \"Systemic Light Chain Amyloidosis\";\n2. No other severe systemic underlying diseases that affect the examination;\n3. Subjects voluntarily participate in this study, sign the informed consent form;\n4. Age between 18-80 years old, no gender restrictions.\n\nExclusion Criteria:\n\n1. Patients with eye diseases of clear causes such as ocular surface malignant tumors, corneal perforation, severe eye trauma, etc.;\n2. Patients with nystagmus;\n3. Severe ocular scar diseases; conjunctival scars with fornix shortening;\n4. Current signs of infection, including fever and undergoing antibiotic treatment;\n5. Mental abnormalities;\n6. Pregnant or breastfeeding women, or women planning to become pregnant within 2 years.",true,{"count":109,"type":20},130,"OBSERVATIONAL","Study Purpose and Principle: Amyloidosis is a group of diseases characterized by the deposition of amyloid proteins in tissues and organs throughout the body, with common affected organs including kidneys, heart, nervous system, gastrointestinal tract, and liver. Nowadays, nearly 40 different proteins have been found to form amyloid fibrils in body, among which Systemic Light Chain (AL) Amyloidosis is the most common type of systemic amyloidosis. AL amyloidosis is a plasma cell disorder, with its precursor protein originating from free light chains produced by abnormal plasma cell clones, which form amyloid substances that deposit in tissues and organs causing lesions. In terms of incidence, the incidence of AL amyloidosis is 8-10 cases per million person-years in the United States and is considered a rare disease in our country. AL amyloidosis has an insidious onset, diverse clinical manifestations, and is prone to misdiagnosis and missed diagnosis in clinical practice. The prognosis also has strong heterogeneity and is closely related to the extent of organ involvement at the time of diagnosis. In the past, the incidence of eye involvement in systemic AL amyloidosis patients was low, with various manifestations, only reported as case reports, and not regularly followed up with systemic treatment. Based on this, this project aims to assess the involvement of eyes and its appendages in patients with different stages of systemic light chain amyloidosis, with the goal of clarifying the ocular manifestations of this systemic disease and exploring early diagnostic indicators for the eye.\n\nPrimary Objective: To assess the involvement of the anterior segment of the eye, as well as the extraocular soft tissues and muscles, in patients with systemic light chain amyloidosis.\n\nSecondary Objective: To assess the neuro-ophthalmic manifestations and changes in retinal choroidal blood flow in patients with systemic light chain amyloidosis.\n\nStudy Design: Observational study.\n\nStudy Population and Expected Enrollment: 80 patients with systemic light chain amyloidosis, 50 normal controls.\n\nStudy Duration: Six months of follow-up after the last subject is diagnosed and enrolled.\n\nIntervention: Experimental Group: Patients with systemic light chain amyloidosis; Control Group: Subjects without systemic diseases.",[28,113],"Ocular Complications",[28,113],"2025-01-26",{"date":117,"type":40},"2025-01-31",{"date":119,"type":40},"2024-09-04",{"date":121,"type":20},"2026-08-13",{"name":123,"class":47},"Zhongshan Ophthalmic Center, Sun Yat-sen University"]