[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"light-chain-amyloidosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:light-chain-amyloidosis":90},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,50,74,101],{"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":26,"conditions":27,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100599219","phase-1-a-phase-1b2-study-of-car-t-cell-therapy-targeting-cd19-and-bcma-in-participants-with-relapsed-or-refractory-al-amyloidosis-100599219",false,"NCT07081646","A Phase 1b\u002F2 Study of CAR T Cell Therapy Targeting CD19 and BCMA in Participants With Relapsed or Refractory AL Amyloidosis.","A Phase 1b\u002F2 Study of AZD0120 (Also Known as GC012F), a Chimeric Antigen Receptor T Cell Therapy Targeting CD19 and B Cell Maturation Antigen in Participants With Relapsed or Refractory AL Amyloidosis.","ALACRITY","Inclusion Criteria:\n\n* Confirmed histopathological diagnosis of AL amyloidosis\n* One or more organs currently or historically impacted by AL amyloidosis according to consensus guidelines\n* Measurable hematologic disease: dFLC \\> 20 mg\u002FL or serum M-protein \\> 5g\u002FL\n* Relapsed or refractory disease with a need for additional therapy after at least 1 line of anti-plasma cell-directed therapy.\n* ECOG performance status of 0 to 2\n* Must be able and willing to adhere to the study visit schedule and other protocol requirements\n* Women of child-bearing potential (WCBP) must have a negative serum and\u002For urine pregnancy test result prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use highly effective methods of birth control throughout the study.\n\nExclusion Criteria:\n\n* Have any other form of amyloidosis other than AL amyloidosis\n* Mayo Stage IIIb AL amyloidosis\n* Oxygen saturation \\\u003C 95% on room air\n* Systolic blood pressure \\\u003C100mmHg\n* NYHA class III or IV\n* Extensive GI involvement with evidence of active GI bleeding\u002Frisk of bleeding as determined by Investigator\n* Prior therapies:\n\n  1. CAR T cell therapy directed at any target\n  2. Prior BCMA-targeting therapy\n  3. Prior treatment with any FDA approved or investigational T cell engaging therapies (including T cell-directed bispecific or trispecific therapies) at any target within the last 6 months.\n* Toxicity from previous anti-cancer or anti-PC-directed therapy did not resolve to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy.\n* Active plasma cell leukemia at the time of screening\n* Symptomatic multiple myeloma (defined as clonal bone marrow plasma cells ≥10% plus at least one myeloma-defining event per IMWG 2014)","ALL","18 Years",{"count":20,"type":21},91,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Open-label Phase 1b\u002F2 study with primary objective of this study is to evaluate the safety, tolerability and efficacy of AZD0120 in participants with light chain (AL) amyloidosis.",[28,29,30,31],"Relapsed AL Amyloidosis","Refractory AL Amyloidosis","Light Chain Amyloidosis","Amyloidosis",[33,34,35,36],"AZD0120","AL Amyloidosis","CAR-T","Cell Therapy","RECRUITING","2026-07-01",{"date":40,"type":41},"2026-07-02","ACTUAL",{"date":43,"type":41},"2025-08-18",{"date":45,"type":21},"2031-02-14",{"name":47,"class":48},"Alexion Pharmaceuticals, Inc.","INDUSTRY",18,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100591709","exploratory-clinical-study-on-the-safety-and-efficacy-of-targeted-bcma-autologous-cart-cell-injection-in-subjects-with-recurrentrefractory-light-chain-amyloidosis-100591709","NCT06983951","Exploratory Clinical Study on the Safety and Efficacy of Targeted BCMA Autologous CART Cell Injection in Subjects With Recurrent\u002FRefractory Light Chain Amyloidosis","Exploratory Clinical Study Evaluating the Safety and Efficacy of Targeted BCMA Autologous CART Cell Injection in Subjects With Recurrent\u002FRefractory Light Chain Amyloidosis","Inclusion Criteria:\n\n\\- Participants must meet all inclusion criteria, and only those who do not meet any exclusion criteria can be enrolled\n\n1. Participants must personally sign the informed consent form approved by the ethics committee in writing before the start of the study;\n2. The age of the subject is ≥ 18 years old;\n3. Diagnosed with light chain amyloidosis through pathological examination;\n4. Subjects with recurrent\u002Frefractory light chain amyloidosis who have previously received second-line or higher treatment;\n5. dFLC \\> 50mg\u002FL\n6. Expected survival period ≥ 12 weeks;\n7. ECOG score ≤ 2 points;\n8. Female subjects with fertility should agree to take effective contraceptive measures from the date of signing the informed consent form until 365 days after reinfusion. Effective contraceptive measures are defined as abstinence or using contraceptive methods with an annual failure rate of less than 1% as specified in the plan;\n9. Prior to enrollment, participants must have appropriate organ function and meet all of the following test results:\n\n9.1 Absolute neutrophil count ≥ 1.0 × 109\u002FL \\[allowed to use granulocyte colony-stimulating factor (G-CSF) support\\]; 9.2 Platelet count ≥ 50 × 109\u002FL; 9.3 Hemoglobin ≥ 8 g\u002Fdl; 9.4 Bilirubin value ≤ 1.5 x upper limit of normal (ULN); 9.5 ALT or AST ≤ 2.5 times the upper limit of normal (ULN) (with liver involvement ≤ 5 times the upper limit of normal); 9.6 Mayo 2004 Stage I-IIIa participants; 9.7 Stable coagulation function: INR ≤ 1.5, APTT ≤ 1.2 x upper limit of normal (ULN); Basic blood oxygen saturation is greater than 92% in indoor natural air environment.\n\nExclusion Criteria:\n\n\\-\n\nSubjects who meet any of the following criteria will be excluded:\n\n1. Subjects who have received the following previous treatments:\n\n   1.1 Individuals who have received gene therapy prior to enrollment; 1.2 Subjects who received live vaccines within 4 weeks prior to enrollment; 1.3 Received other intervention clinical drug treatments within 12 weeks prior to single collection;\n2. Patients with central involvement or complete intestinal obstruction;\n3. Patients with moderate to severe pleural and peritoneal effusion who are difficult to control with conventional treatment and require continuous catheterization and drainage;\n4. Active malignant tumors within the past 5 years, unless they are curable tumors that have been significantly cured, such as basal or squamous cell carcinoma, cervical or breast carcinoma in situ, etc;\n5. Subjects with positive hepatitis B B surface antigen (HBsAg) and abnormal detection of HBV DNA in peripheral blood (abnormal detection of HBV DNA is defined as: quantitative detection of HBV DNA is higher than the detection limit of the testing center or higher than the normal reference value range of the testing center or positive qualitative detection of HBV DNA); Individuals with positive hepatitis C virus (HCV) antibodies and positive hepatitis C virus (HCV) RNA in peripheral blood; Individuals who are HIV antibody positive; Individuals who test positive for Cytomegalovirus (CMV) DNA; Positive RPR results in syphilis testing;\n6. There are uncontrollable active infections (excluding CTCAE grade 2 urinary and reproductive system infections and upper respiratory tract infections);\n7. Severe heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification ≥ III), 24-hour dynamic electrocardiogram showing ventricular arrhythmia and atrioventricular block, positive six minute walk test, interventricular septum and left ventricular posterior wall thickness\\>1.5cm;\n8. Hypertensive subjects who cannot be controlled by drug treatment;\n9. Previous treatment toxicity reactions have not improved to baseline or ≤ grade 1 (NCI-CTCAE v5.0 version, except for hair loss and clinically insignificant laboratory test abnormalities);\n10. Have undergone major surgery within 2 weeks prior to enrollment, or plan to undergo surgery during the waiting period for reinfusion or within 12 weeks after receiving study treatment (excluding planned local anesthesia surgery);\n11. Solid organ transplant recipients;\n12. Pregnant or lactating women;\n13. Subjects with previous central nervous system disorders (such as cerebral aneurysms, epilepsy, stroke, senile dementia, mental illness, etc.) or consciousness disorders;\n14. Other researchers have identified unstable systemic diseases, including but not limited to severe liver, kidney, or metabolic diseases that require drug treatment;\n15. Known to have life-threatening allergic reactions, hypersensitivity reactions, or intolerance to cellular preparations or their components;\n16. Patients diagnosed by researchers as having bleeding, severe thrombosis, or genetic\u002Facquired bleeding and severe thrombosis (including hemophilia, coagulation dysfunction, thrombocytopenia, splenomegaly, etc.), or patients undergoing thrombolytic or anticoagulant therapy; Researchers believe that there are other situations that are not suitable for inclusion.",{"count":58,"type":21},30,[60],"NA","This study is a multicenter, open label, fixed dose exploratory clinical trial with an expected enrollment of 30 subjects. The main objective is to evaluate the safety of targeted BCMA autologous CART cell injection in the treatment of recurrent or refractory light chain amyloidosis in subjects, preliminarily verify the effectiveness of targeted BCMA autologous CART cell injection in the treatment of recurrent or refractory light chain amyloidosis in subjects, and explore the pharmacokinetic, pharmacodynamic, and immunogenic characteristics of targeted BCMA autologous CART cell injection after reinfusion.",[30],"2025-05-14",{"date":65,"type":41},"2025-05-21",{"date":67,"type":41},"2025-02-20",{"date":69,"type":21},"2027-09-30",{"name":71,"class":72},"Beijing Boren Hospital","OTHER",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":73},"100590742","phase-2-study-of-hbi0101-nxc-201-car-t-therapy-in-multiple-myeloma-and-light-chain-amyloidosis-100590742","NCT06971380","Study of HBI0101 (NXC-201) CAR-T Therapy in Multiple Myeloma and Light-Chain Amyloidosis","A Phase 2 Trial to Study Efficacy and Safety of HBI0101 (NXC-201) CART in Subjects With Multiple Myeloma and Light-Chain Amyloidosis.","Inclusion Criteria:\n\n1. ≥18 years of age at the time of signing informed consent.\n2. Voluntarily signed informed consent form.\n3. Diagnosis of multiple myeloma and\u002For light-chain amyloidosis with relapsed or refractory disease, with measurable disease at screening visit\n4. Subject suffering from multiple myeloma must have been exposed to at least two prior lines of therapy including proteasome inhibitor, immunomodulatory (IMiDs) therapy or anti-CD38 antibody, or functionally high-risk patients (i.e. first relapse within 18 months of treatment initiation) may be included.\n\n   Subject with amyloidosis must have been exposed to at least one prior line of therapy which includes proteasome inhibitor or anti-CD38 antibody, or subjects with insufficient response (i.e. not achieving a VGPR or CR after exposure to at least an anti-CD38 antibody and a proteasome inhibitor) may be included.\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.\n6. Women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation or who has not been naturally postmenopausal for at least 24 consecutive months, must have a negative serum pregnancy test prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use effective methods of birth control throughout the study.\n7. Recovery to ≤ Grade 2 or baseline of any non-hematologic toxicities due to prior treatments, excluding alopecia and Grade 3 neuropathy.\n8. Ability and willingness to adhere to the study visit schedule and all protocol requirements.\n9. Subjects with relapsed multiple myeloma who have previously undergone allogenic stem cell transplantation must have no evidence of graft versus host disease after cessation of any immunosuppressive therapy for at least one month before recruitment to the study.\n\nExclusion Criteria:\n\n1. Contraindication to a study treatment\u002Fprocedure or is anticipated to receive treatment\u002Fprocedure that may preclude performance of study procedures.\n2. Known bulky central nervous system disease.\n3. Inadequate hepatic function defined by aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) \\> 2.5 x upper limit of normal (ULN) and direct bilirubin \\> 4x ULN.\n4. Inadequate renal function defined by serum creatinine clearance\u002Festimated clearance of \\\u003C20(ml\u002Fmin).\n5. International ratio (INR) or partial thromboplastin time (PTT) \\> 2 x ULN, unless on a stable dose of anticoagulant for a thromboembolic event (provided this event is not an exclusion criteria).\n6. Inadequate bone marrow function defined by absolute neutrophil count (ANC) \\\u003C 1000 cells\u002Fmm\\^3, platelet count \\\u003C 30,000 mm\\^3, or hemoglobin \\\u003C 8 g\u002FdL. Subjects with absolute lymphocyte count \\\u003C 300 cells\u002Fmm\\^3 may be excluded (due to potential challenges with producing CART cells), per investigator judgement.\n7. Echocardiogram with left ventricular ejection fraction \\\u003C 40%.\n8. Ongoing treatment with chronic immunosuppressant such as cyclosporine or systemic steroids (physiological replacement doses of steroids are allowed up to 12 mg\u002Fm\\^2\u002Fd hydrocortisone or equivalent)\n9. Significant co-morbid condition or disease which in the judgment of the Investigator would place the subject at undue risk or interfere with the study; examples include, but are not limited to, cirrhotic liver disease, sepsis, recent significant traumatic injury, and other conditions.\n10. Known human immunodeficiency virus (HIV) positive status.\n11. Active Hepatitis B or Hepatitis C active infection.\n12. Active CMV infection.\n13. Known history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within 3 months.\n14. Chronic atrial fibrillation with uncontrolled heart rate.\n15. Second primary malignancies that has required therapy in the last 2 years or is not in complete remission.\n16. Subjects who have had a venous thromboembolic event (e.g., pulmonary embolism or deep vein thrombosis) requiring anticoagulation and who meet any of the following criteria:\n\n    1. Have been on a stable dose of anticoagulation for \\\u003C 1 month (except for acute line insertion induced thrombosis.)\n    2. Have had a Grade 2, 3, or 4 hemorrhage in the last 30 days\n    3. Are experiencing continued symptoms from their venous thromboembolic event (e.g. continued dyspnea or oxygen requirement).\n17. Pregnant or lactating women.\n18. Participation in another interventional clinical trial within 30 days prior to screening visit.",{"count":82,"type":21},180,[25],"A Phase II study of HBI0101 (NXC-201) BCMA-CART in Multiple Myeloma and Light-chain Amyloidosis Patients. The goal of the study is to evaluate the efficacy and safety of HBI0101 CART.",[86,87,30],"Multiple Myeloma, Refractory to Standard Treatment","Multiple Myeloma, Relapsed",[89,90,91,92],"Relapsed\u002FRefractory Multiple Myeloma","Light-Chain Amyloidosis","B-cell maturation antigen (BCMA)","Autologous CAR-T","2025-05-06",{"date":63,"type":41},{"date":96,"type":41},"2025-03-01",{"date":98,"type":21},"2030-05-15",{"name":100,"class":72},"Polina Stepensky",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":112,"conditions":113,"keywords":114,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":73},"100514450","phase-1-fkc288-for-relapsed-or-refractory-systemic-light-chain-al-amyloidosis-100514450","NCT05978661","FKC288 for Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis","A Single-Center Exploratory Study to Evaluate the Safety and Efficacy of FKC288 in Subjects With Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis","Inclusion Criteria:\n\n1. The subject must personally sign a written informed consent form approved by the ethics committee before the start of the study;\n2. The subject's age is ≥18 years old and \\\u003C70 years old;\n3. The subject must be diagnosed with light chain amyloidosis by pathological examination, with at least one major organ involved (heart, kidney, or liver);\n4. The subject with recurrent\u002Frefractory light chain amyloidosis that achieved no response with conventional treatment;\n5. dFLC \\> 50mg\u002FL;\n6. Expected survival ≥ 12 weeks;\n7. ECOG score ≤ 2 points;\n8. Female subjects with fertility should agree to practice an effective method of contraception from the day of signing the ICF until 365 days after the infusion. An effective method of contraception is defined as abstinence or contraceptive methods with an annual failure rate of \\\u003C1% specified in the plan.\n9. Before enrollment, the subject must have appropriate organ function and meet all the following criteria:\n\n1\\) Absolute neutrophil count ≥ 1.0×109\u002FL (use of granulocyte colony-stimulating factor (G-CSF) support is allowed, but must be without supportive treatment within 7 days before the examination); 2) Platelet count ≥ 75×109\u002FL (no transfusion support \\[including component transfusion\\] or treatments aimed at raising platelets such as thrombopoietin \\[TPO\\] should be received within 7 days before the examination); 3) Hemoglobin ≥ 9 g\u002Fdl (no transfusion support \\[including component transfusion\\] should be received within 7 days before the examination); 4) Bilirubin value ≤ 1.5× upper limit of normal (ULN) (except bile duct obstruction caused by tumor compression); 5) Creatinine clearance rate ≥ 40 ml\u002Fmin; 6) ALT or AST ≤ 2.5× ULN (≤5 times the upper limit of normal in patients with liver involvement); 7) Echocardiography results indicate left ventricular ejection fraction ≥ 50% with no significant pericardial effusion; 8) NTproBNP \\\u003C 1800pg\u002Fml, TNT \\\u003C 0.06ng\u002Fml; 9) Stable coagulation function: INR ≤ 1.5, APTT ≤ 1.2× ULN (excluding tumor-related anticoagulant therapy); 10) \\>95% basic blood oxygen saturation in the natural indoor air environments.\n\nExclusion Criteria:\n\n1. Subjects who have received any of the following treatments prior to enrollment: 1) Subjects who have received gene therapy before enrollment; 2) Subjects who have received live vaccines within 4 weeks prior to enrollment; 3) Subjects has received other interventional clinical research drugs within 12 weeks before apheresis.\n2. Subjects with central metastasis or complete intestinal obstruction.\n3. Subject with moderate or more severe hydrothorax and ascites which are hard to control by conventional treatment and require continuous catheter drainage.\n4. With an active malignant tumor in the past 5 years, unless it is a curable tumor and has been obviously cured.\n5. Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and have abnormal peripheral blood HBV DNA test results (HBV DNA test abnormality is defined as HBV DNA quantitative detection is higher than the detection center's detection lower limit or higher than the detection center's normal reference range or HBV DNA qualitative detection is positive); hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA positive; human immunodeficiency virus (HIV) antibody positive; the cytomegalovirus (CMV) DNA positive; syphilis testing RPR positive.\n6. Presence of uncontrollable active infections (excluding \\\u003CCTCAE grade 2 urinary and respiratory tract infections).\n7. Severe cardiovascular diseases, including but not limited to unstable angina pectoris, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥ III), and severe arrhythmias.\n8. Subjects with hypertension that cannot be controlled by medication.\n9. Toxicity reactions that have not been relieved to baseline or ≤ grade 1 (NCI-CTCAE version 5.0, except for hair loss and laboratory test abnormalities without clinical significance) from past treatments.\n10. Major surgery within 2 weeks before enrollment, or has a surgery planned during the time the subject is expected to be infused with FKC288 or within 12 weeks after FKC288 infusion (except planned surgery under local anesthesia).\n11. Subject who has a solid organ transplant.\n12. Women who are pregnant or breastfeeding.\n13. Subjects with previous central nervous system diseases (such as cerebral aneurysm, epilepsy, stroke, dementia, psychosis, etc.) or conscious disorders.\n14. Other systemic diseases that the investigator judges as unstable, including but not limited to severe liver, kidney, or metabolic diseases that require medication.\n15. Known life-threatening allergic reactions, hypersensitivity reactions, or intolerance to FKC288 cell preparations or their components.\n16. Subjects judged by the investigator to have bleeding or severe thrombosis, or have inherited\u002Facquired bleeding and severe thrombosis (including hemophilia, coagulation dysfunction, thrombocytopenia, splenomegaly, etc.), or are receiving thrombolysis or anticoagulation therapy.\n17. Other situations deemed inappropriate for inclusion by the investigator.","70 Years",{"count":110,"type":21},12,[24],"This study is a single-center exploratory clinical trial. It is estimated that 6-12 subjects will be enrolled. The \"BOIN\" dose escalation design is adopted. The main purpose is to evaluate the safety of FKC288 in the treatment of subjects with relapsed or refractory AL amyloidosis and explore the recommended phase II dose of FKC288 in the treatment of patients with relapsed\u002Frefractory systemic Light Chain (AL) amyloidosis.",[30],[34,115],"BCMA\u002FCD19-CAR-T cell","2023-11-13",{"date":118,"type":41},"2023-11-15",{"date":120,"type":41},"2023-08-29",{"date":122,"type":21},"2026-06",{"name":124,"class":72},"Nanjing University School of Medicine"]