[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"al-amyloidosis-al\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:al-amyloidosis-al":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"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":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100618766","phase-2-sonrotoclax-plus-dexamethasone-with-or-without-daratumumab-regimen-in-patients-with-t1114-primary-al-amyloidosis-100618766",false,"NCT07335887","Sonrotoclax Plus Dexamethasone With or Without Daratumumab Regimen in Patients With t(11;14) Primary AL Amyloidosis","An Optimized Treatment for Patients With Primary Systemic Light Chain Amyloidosis","Inclusion Criteria:\n\n1. Patients who meet the diagnostic criteria for Primary Systemic Light Chain Amyloidosis (according to the Systemic Light Chain Amyloidosis Diagnosis and Treatment Guidelines (2021 Revision)).\n2. Age ≥ 18 years.\n3. Confirmed FISH test result of t(11;14) positive by each center or a third-party laboratory, or a prior FISH test report indicating t(11;14) positivity\n4. ECOG Performance Status score of 0-2.\n5. Presence of measurable disease, defined by at least one of the following criteria:\n\n   1. Serum M-protein ≥ 0.5 g\u002FdL\n   2. Serum free light chain (FLC) level ≥ 40 mg\u002FL with an abnormal kappa\u002Flambda ratio.\n6. Adequate organ function, defined as:\n\n   1. Hemoglobin (HGB) \\> 80 g\u002FL\n   2. Platelet count \\> 50 × 10⁹\u002FL\n   3. Absolute neutrophil count (ANC) \\> 1.0 × 10⁹\u002FL\n   4. Total bilirubin ≤ 2.0 × ULN; AST and ALT ≤ 3.0 × ULN\n   5. Creatinine clearance (CrCl) ≥ 30 mL\u002Fmin\n   6. Oxygen saturation ≥ 90%\n7. Life expectancy greater than 6 months.\n8. Patient understands and voluntarily signs an informed consent form (ICF).\n9. Cohort Assignment:\n\n   * Cohort A: Includes patients who are newly diagnosed or have not been previously exposed to anti-CD38 monoclonal antibody therapy.\n   * Cohort B: Includes patients who are insensitive to or have relapsed after anti-CD38 monoclonal antibody therapy.Insensitivity to anti-CD38 monoclonal antibody therapy is defined as failure to achieve at least a Partial Response (PR) after 1 cycle, or failure to achieve at least a Very Good Partial Response (VGPR) after 3 cycles of an anti-CD38-containing regimen.\n\nExclusion Criteria:\n\n1. Meets the diagnostic criteria for active multiple myeloma or active lymphoplasmacytic lymphoma\n2. Presence of other malignancies at an advanced stage with systemic metastases.\n3. IgM-type AL amyloidosis.\n4. Prior treatment with a BCL-2 inhibitor (BCL-2i).\n5. Presence of any of the following severe cardiovascular diseases\n\n   1. Mayo 2004 stage IIIb: NT-proBNP \\>8500 ng\u002FL.\n   2. NYHA class IIIb-IV\n   3. Left ventricular ejection fraction (LVEF) \\\u003C40%.\n   4. QT interval corrected by Fridericia's formula (QTcF) \\>480 ms\n   5. Investigator assessment that heart failure is due to ischemic heart disease (e.g., prior history of myocardial infarction with elevated cardiac enzymes and ECG changes) or uncorrected valvular disease, rather than primarily caused by AL amyloidosis.\n   6. Hospitalization for unstable angina or myocardial infarction within 6 months prior to the first dose, or cardiac interventional therapy or coronary artery bypass grafting within 6 months.\n   7. For patients with congestive heart failure, hospitalization for cardiovascular disease within 4 weeks prior to Cycle 1 Day 1.\n   8. History of sustained ventricular tachycardia or aborted ventricular fibrillation, or history of atrioventricular node or sinus node dysfunction requiring a pacemaker\u002Fimplantable cardioverter-defibrillator (ICD) but not implanted.\n6. Severe or persistent infection that is not effectively controlled. (Acute infection requiring antibacterial, antifungal, or antiviral therapy that has not resolved within 14 days prior to dosing).\n7. Positive status for human immunodeficiency virus (HIV) antibody (HIVAb).\n8. Serological status reflecting active viral hepatitis B (HBV) or hepatitis C (HCV) infection, as follows:\n\n   1. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Patients who are positive for HBcAb but negative for HBsAg are eligible if HBV DNA is undetectable and they are willing to undergo monthly monitoring for HBV reactivation.\n   2. Positive for hepatitis C virus (HCV) antibody. Patients who are positive for HCV antibody are eligible if HCV RNA is undetectable.\n9. Patients receiving renal replacement therapy.\n10. Patients with known hypersensitivity to any component of the investigational regimen.\n11. Any condition that, in the investigator's judgment, would increase the risk to the subject or affect the study results.\n12. Patients with AL amyloidosis currently participating in other investigational drug clinical studies.\n13. Patients who are pregnant, breastfeeding, or planning to become pregnant during the study participation.\n14. Patients who are receiving any moderate or strong CYP3A4 inhibitors (within ≤7 days or 5 half-lives, whichever is shorter) or strong CYP3A4 inducers (within ≤14 days or 5 half-lives, whichever is shorter) prior to the first dose of the study drug; or patients who require continuous treatment with moderate or strong CYP3A inhibitors or strong CYP3A inducers","ALL","18 Years",{"count":19,"type":20},39,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The goal of this study is to evaluate the efficacy and safety of Sonrotoclax combined Regimen in patients with t(11;14) AL amyloidosis. Participants will receive the Sonrotoclax Plus Dexamethasone regimen with or without Daratumumab for 12 cycles. The Hematologic Response, Organ Response, Survival, and Safety will be evaluated.",[26,27],"AL Amyloidosis (AL)","t(11;14) Positive",[29,30,31,32],"sonrotoclax","AL amyloidosis","t(11;14)","BCL-2i","NOT_YET_RECRUITING","2026-01-12",{"date":36,"type":37},"2026-01-13","ACTUAL",{"date":39,"type":20},"2026-01-01",{"date":41,"type":20},"2029-01-31",{"name":43,"class":44},"Peking University People's Hospital","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100599520","early-phase-1-safety-and-efficacy-of-metabolically-armed-bcma-car-t-cells-meta10-bcma-in-the-treatment-of-rr-plasma-cell-neoplasms-clinical-research-100599520","NCT07085559","Safety and Efficacy of Metabolically Armed BCMA CAR-T Cells (Meta10-BCMA) in the Treatment of r\u002Fr Plasma Cell Neoplasms Clinical Research","Inclusion Criteria:\n\n* Age 19 to 75 years old, male or female. The subject or his\u002Fher guardian voluntarily signed the informed consent;\n* Subjects with relapsed or refractory Plasma Cell Neoplasms（including Multiple Myeloma, Plasma Cell Leukemia, AL Amyloidosis）according to IMWG criteria and have had at least 3 prior lines of therapy (including chemotherapy based on proteasome inhibitors and immunomodulatory agents). Disease progression must be documented during or within 12 months following the most recent anti-myeloma treatment (for subject whose last-line treatment was CAR-T, disease progression was not limited to occurring within 12 months after treatment).\n* Evidence of cell membrane BCMA expression, as determined by a validated immunohistochemistry (IHC) or flow cytometry of tumor tissue.\n* The subjects were unable to receive autologous hematopoietic stem cell transplantation treatment, or relapsed after autologous hematopoietic stem cell transplantation, and the researchers determined that treatment was needed.\n* ECOG performance score 0-2 (except for subjects with central nervous system invasion, which needs to be confirmed by the investigator).\n* Estimated life expectancy≥12 weeks.\n* Subjects should have adequate organ function:\n\n  1. Complete blood count (CBC) test \\[the following criteria should be met within 24 hours prior to apheresis, and supportive treatment such as transfusion, platelet transfusion, cell growth factor (except recombinant erythropoietin) should be avoided within 7 days prior to detection\\]: Absolute neutrophil count (ANC) ≥1×10\\^9 \u002FL; hemoglobin ≥70 g\u002FL.; platelets ≥50×10\\^9 \u002FL; absolute lymphocyte count (ALC) ≥0.3×10\\^9 \u002FL;\n  2. Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×upper limit of normal (ULN); total serum bilirubin ≤ 1.5×ULN.\n  3. Kidney function: Serum creatinine ≤2.5×upper limit of normal (ULN), or； Creatinine clearance rate (CrCl) calculated according to Cockcroft-Gault formula ≥ 60 ml\u002Fmin.\n  4. Electrolytes: Serum potassium ≥ 3.0 mmol\u002FL; Serum calcium ≥ 2.0 mmol\u002FL; Serum magnesium ≥ 0.5 mmol\u002FL.\n  5. Coagulation function: Fibrinogen ≥ 1.0 g\u002FL; activated partial thromboplastin time (APTT) ≤ ULN+10s, prothrombin time (PT) ≤ ULN+3s.\n  6. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%.\n* The subjects must be willing to provide valid initial diagnostic evidence and undergo bone marrow examinations before and after treatment.\n* Women of childbearing age and all male patients must consent to use a effective contraception for at least 12 months after Meta10-BCMA infusion and until two consecutive PCR tests show no more CAR T cells in vivo；\n* The subjects should have measurable disease based on at least one of the following parameters:\n\n  1. The proportion of primitive naive or monoclonal plasma cells ≥ 5% by bone marrow cytology, bone marrow biopsy histology or flow cytometry;\n  2. Serum monoclonal protein (M-protein) level: M protein ≥10 g\u002FL for IgG type, M protein ≥5g\u002FL for IgA, IgD, IgM, and IgE type;\n  3. Urine M protein level ≥200 mg\u002F24 hours;\n  4. Light chain multiple myeloma without measurable lesions in serum or urine: the affected serum free light chain ≥100 mg\u002FL with abnormal serum κ\u002Fλ free light chain ratio;\n  5. There are measurable extramedullary plasmacytoma lesions.\n\nExclusion Criteria:\n\n* Treatment with the following therapies within the specified period:\n\n  1. Any hematopoietic stem cell transplant(HSCT) within 2 months prior to the start of infusion of Meta10-BCMA, or any immunosuppressive therapy due to graft-versus-host disease after HSCT within the screening period;\n  2. Any major surgery within 4 weeks prior to screening;\n  3. Any radiotherapy 2 weeks prior to screening;\n  4. Any intrathecal treatment within 1 week prior to the start of infusion of Meta10-BCMA;\n  5. Any live vaccination within 4 weeks prior to the start of infusion of Meta10-BCMA and\u002For plan to receive live vaccines after participation in the trial;\n  6. Any clinical trial therapy within 4 weeks prior to the start of infusion of Meta10-BCMA, or ongoing participation in other clinical trials.\n* Following disease or surgical history:\n\n  1. ≥ grade 2 arrhythmia according to NCI CTCAE 5.0 grade or QTc\\> 450 ms (male), QTc\\> 470ms (female) (QTc is calculated using Fridericia correction formula QTc = QT \u002F RR0.33) subjects with a history of Torsades de pointes ventricular tachycardia or congenital prolonged QT syndrome;\n  2. Subjects with any of the following diseases within 12 months before the screening: including but not limited to unstable angina pectoris, myocardial infarction, congestive heart failure and severe arrhythmia, coronary artery bypass grafting or peripheral artery bypass grafting surgery, cerebrovascular events (including transient ischemic attacks), etc.;\n  3. Uncontrollable and active infections during the screening period regarded by the investigators;\n  4. Subjects infected with human immunodeficiency virus (HIV);\n  5. Subjects with active hepatitis B (defined as hepatitis B surface antigen positive or hepatitis B core antibody positive, concomitant hepatitis B virus DNA level \\> 100 IU\u002Fml);\n  6. The hepatitis C virus (HCV) antibody is positive, and the peripheral blood HCV RNA is positive;\n  7. Subjects with severe electrolyte disturbance regarded by the investigators;\n  8. Subjects with a clear gastrointestinal bleeding tendency, including the following: active local ulcer lesions, and fecal occult blood (≥ ++); subjects with a history of melena and hematemesis within two months prior to screening; Subjects who may have a major gastrointestinal bleeding history;\n  9. Subjects with a history of solid organ transplantation;\n  10. Subjects with other acute, severe, or chronic medical or psychological conditions regarded by investigators as not suitable for enrollment;\n  11. Pregnant or lactating women.\n* Prohibited treatment and\u002For medication:\n\n  1. Ongoing therapy with other anti-tumor drugs, including traditional Chinese medicine;\n  2. On-going therapy with drugs that extend the QT interval (including Class Ia and III antiarrhythmic drugs);\n  3. Subjects who need to receive oxygen daily;\n  4. Long-term use of corticosteroids (except for local inhalation).\n* Others:\n\n  1. Subject with a history of psychotropic substance abuse who are unable to quit or have mental disorders;\n  2. Subjects with concomitant diseases or comorbidities that could seriously endanger the safety of the patient or affect the completion of the trial as judged by the investigators;\n  3. There are not enough unmobilized mononuclear cells available for collection for CAR-T cell production.","19 Years","75 Years",{"count":54,"type":20},36,[56],"EARLY_PHASE1","A Study of Metabolically Armed BCMA CAR-T Cells Therapy for Patients With Relapsed and\u002For Refractory Plasma Cell Neoplasms.",[59,60,26],"Multiple Myeloma (MM)","Plasma Cell Leukemia (PCL)",[62,63,64],"Meta10-BCMA","CAR-T Cells Therapy","r\u002Fr plasma cell neoplasms","RECRUITING","2025-07-24",{"date":68,"type":37},"2025-07-25",{"date":70,"type":37},"2025-06-23",{"date":72,"type":20},"2027-10-15",{"name":74,"class":75},"Anhui Provincial Hospital","OTHER_GOV",1]