[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Institute of Hematology & Blood Diseases Hospital, China\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":564},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,252,0,25,[9,42,64,85,107,132,153,173,195,219,240,260,283,303,321,348,368,387,407,433,457,478,499,518,544],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100651256","autologous-hematopoietic-stem-cell-transplantation-for-neurological-damage-associated-with-hereditary-homocysteine-remethylation-disorders-100651256",false,"NCT07757685","Autologous Hematopoietic Stem Cell Transplantation for Neurological Damage Associated With Hereditary Homocysteine Remethylation Disorders","Exploratory Clinical Study of Autologous Hematopoietic Stem Cell Transplantation for Neurological Damage Associated With Hereditary Homocysteine Remethylation Disorders","Inclusion Criteria:\n\n1. Aged 18 to 55 years, regardless of gender.\n2. Comprehensive clinical, biochemical, and genetic diagnosis of hereditary homocysteine remethylation disorders.\n3. Evidence of neurological involvement, including but not limited to gait disturbance, balance impairment, cognitive dysfunction, cerebral white matter lesions.\n4. Prior standardized metabolic therapy (folic acid, vitamin B12, betaine) with suboptimal clinical response.\n5. Persistent severe metabolic abnormality, i.e., sustained elevated homocysteine (\\>50 umol\u002FL).\n6. Multidisciplinary consensus confirming lack of effective alternative therapies and ongoing risk of disease progression.\n7. Voluntary participation, signed informed consent, adequate treatment adherence, and willingness to complete follow-up assessments.\n\nExclusion Criteria:\n\n1. Prior hematopoietic stem cell transplantation or other cell transplantation.\n2. Severe dysfunction of critical organs (heart, lung, liver, kidney) deemed incompatible with study treatment by investigators.\n3. Active, uncontrolled infection.\n4. Active tuberculosis, hepatitis B, hepatitis C, HIV infection, or other infectious diseases judged inappropriate for enrollment by investigators.\n5. Active malignancy or prior malignant history that may confound safety and efficacy evaluations.\n6. Severe underlying comorbidities likely to interfere with study treatment or outcome assessment.\n7. Severe psychiatric disorder or cognitive impairment with poor adherence precluding completion of treatment and follow-up.\n8. Pregnant or lactating females, or participants unwilling to use effective contraception throughout the study period.\n9. Severe hypersensitivity to any study-related medication or intervention.\n10. Participation in other interventional clinical trials within the past 4 weeks or ongoing observation period of another clinical trial.\n11. No documented disease progression within the preceding 12 months.\n12. Minimal neurological symptoms with no meaningful impact on activities of daily living and low short-term progression risk per investigator assessment.\n13. Established standard therapies proven to alter natural disease history with stable disease and satisfactory therapeutic response.\n14. End-stage disease with extensive irreversible neurological impairment (severe motor\u002Fcognitive failure or multi-organ dysfunction) with minimal expected therapeutic benefit.\n15. Any other conditions deemed unsuitable for study participation by investigators.","ALL","18 Years","55 Years",{"count":21,"type":22},50,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study aims to evaluate the safety, feasibility, and preliminary efficacy of autologous hematopoietic stem cell transplantation (ASCT) in the treatment of neurological damage associated with hereditary homocysteine remethylation disorders. Meanwhile, peripheral blood, cerebrospinal fluid, and related clinical samples will be prospectively collected before and after transplantation to dynamically monitor changes in immune reconstitution and neuroinflammatory biomarkers. The study intends to explore the impact of immune system resetting on disease progression and central nervous system immune microenvironment, providing evidence for subsequent precise patient stratification and optimized therapeutic strategies.",[28],"Hereditary Homocysteine Remethylation Disorder","NOT_YET_RECRUITING","2026-08-05",{"date":32,"type":33},"2026-08-11","ACTUAL",{"date":35,"type":22},"2026-08-01",{"date":37,"type":22},"2030-07-31",{"name":39,"class":40},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",2,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":4},"100651250","phase-1-salvage-chemotherapy-with-sonrotoclax-cladribine-and-standard-dose-cytarabine-sequentially-followed-by-hsct-for-rr-aml-100651250","NCT07757672","Salvage Chemotherapy With Sonrotoclax, Cladribine, and Standard-dose Cytarabine, Sequentially Followed by HSCT for R\u002FR AML.","A Prospective Phase II Clinical Trial of Salvage Chemotherapy With Sonrotoclax, Cladribine, and Standard-dose Cytarabine, Sequentially Followed by Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed\u002FRefractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* 1.Patients with a confirmed diagnosis of relapsed or refractory acute myeloid leukemia (AML) based on bone marrow morphology, immunophenotyping, and cytogenetics.\n* 2\\. Patients who are planned to undergo allogeneic hematopoietic stem cell transplantation, including HLA-matched or HLA-mismatched related allogeneic transplantation, as well as unrelated donor transplantation.\n* 3\\. Age between 18 and 65 years, inclusive, regardless of gender.\n* 4\\. Eastern Cooperative Oncology Group performance status (ECOG) of 0-2.\n* 5\\. Written informed consent must be obtained prior to the initiation of any study-related procedures. For patients aged 18 years or older, the consent form may be signed by the patient or by a direct relative. Should the patient's own signature be judged to be potentially harmful to their clinical care, consent may instead be given by a legal guardian or a direct relative.\n\nExclusion Criteria:\n\n* 1\\. Uncontrolled active infection (bacterial, fungal, or viral).\n* 2\\. Known positive serology for human immunodeficiency virus (HIV) or active hepatitis C virus (HCV).\n* 3\\. Psychiatric disorders or other medical conditions that preclude compliance with the study treatment and monitoring requirements.\n* 4\\. Pregnant patients, or patients who are unwilling or unable to use adequate contraceptive measures during the treatment period.\n* 5\\. Prior hematopoietic stem cell transplantation.\n* 6\\. Active cardiac disease, defined as one or more of the following: History of uncontrolled or symptomatic angina pectoris; Myocardial infarction within 6 months prior to study enrollment; History of arrhythmia requiring medication or clinically significant symptomatic arrhythmia; Uncontrolled or symptomatic congestive heart failure (\\> New York Heart Association \\[NYHA\\] class 2); Ejection fraction below the lower limit of normal; Previous coronary angioplasty or stent implantation.\n* 7\\. Severe hepatic impairment, defined as liver function parameters (ALT, TBIL) \\> 3 × upper limit of normal (ULN); or severe renal impairment, defined as serum creatinine (Cr) \\> 2 × ULN, or 24-hour urine creatinine clearance \\\u003C 50 mL\u002Fmin; or any other condition that, in the investigator's opinion, renders the patient unsuitable for treatment with the study drug.\n* 8\\. Any other condition that, in the investigator's opinion, makes the patient ineligible for study participation.","65 Years",{"count":21,"type":22},[52,53],"PHASE1","PHASE2","The goal of this clinical trial is to treat adult patients with relapsed\u002Frefractory acute myeloid leukemia (AML) using a salvage chemotherapy regimen consisting of Sonrotoclax, cladribine, and standard-dose cytarabine, sequentially followed by allogeneic hematopoietic stem cell transplantation (allo-HSCT). The main questions it aims to answer are:\n\nDoes this treatment regimen improve the 2-year overall survival (OS) rate, relapse-free survival (RFS) rate, and cumulative incidence of relapse (CIR) in this patient population?\n\nWhat is the safety profile of this combination and sequential transplant strategy, particularly regarding treatment-related mortality (TRM) and adverse events?\n\nAs this is a single-arm phase II study, there is no comparator group.\n\nParticipants will:\n\nReceive salvage chemotherapy with cladribine (5 mg\u002Fm² on days 1-5), cytarabine (100 mg\u002Fm² twice daily on days 1-5), and Sonrotoclax (escalating doses from 40 mg to 320 mg on days 1-14).\n\nUndergo allogeneic hematopoietic stem cell transplantation as a bridge therapy within 1 to 4 weeks after completing chemotherapy.\n\nPotentially receive Sonrotoclax as maintenance therapy after hematopoietic reconstitution post-transplant, at the investigator's discretion.\n\nUndergo regular follow-up visits for clinical assessments, disease monitoring, and survival evaluation.",[56,57],"AML (Acute Myelogenous Leukemia","HSCT",{"date":32,"type":33},{"date":60,"type":22},"2026-09-01",{"date":62,"type":22},"2029-04-30",{"name":39,"class":40},{"id":65,"slug":66,"hasResults":12,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":12,"sex":17,"minAge":71,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":23,"phases":74,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":4},"100650927","a-randomized-phase-ii-selection-trial-of-venetoclax-based-induction-intensity-in-newly-diagnosed-acute-myeloid-leukemia-100650927","NCT07754799","A Randomized Phase II Selection Trial of Venetoclax-Based Induction Intensity in Newly Diagnosed Acute Myeloid Leukemia","VISTA-AML- Venetoclax Intensity Selection Trial in AML: A Randomized Phase II Selection Trial of Venetoclax-Based Induction Intensity in Newly Diagnosed Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Diagnosis of AML per WHO (2022) or ICC criteria, and MDS\u002FAML as defined by ICC (with bone marrow blast percentage of 10%-20%).\n* Age ≥14 years, male or female.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Judged by the investigator to be suitable for intensive induction chemotherapy and expected to tolerate the treatment intensity specified in the protocol.\n* Meet the following laboratory test requirements (assessed within 7 days prior to treatment):\n\n  1. Total bilirubin ≤1.5 × upper limit of normal (ULN) for the same age group;\n  2. AST and ALT ≤2.5 × ULN for the same age group;\n  3. Serum creatinine \\\u003C2 × ULN for the same age group;\n  4. Cardiac enzymes \\\u003C2 × ULN for the same age group;\n  5. Cardiac ejection fraction determined by echocardiography (ECHO) within the normal range.\n* Written informed consent must be signed before any study specific procedures are initiated, by the patient themselves or by their immediate family members. If, in consideration of the patient's medical condition, signing by the patient themselves would be detrimental to their treatment, the informed consent may be signed by the legally authorized representative or the patient's immediate family members.\n\nExclusion Criteria:\n\n* Acute promyelocytic leukemia with PML-RARA fusion gene.\n* Acute myeloid leukemia with RUNX1-RUNX1T1 or CBFB-MYH11 fusion gene.\n* Acute myeloid leukemia with BCR-ABL fusion gene.\n* Presence of FLT3 mutation (these patients are recommended to be enrolled in clinical trials of FLT3 inhibitors).\n* Patients who have previously received induction chemotherapy (however, cytoreductive therapy such as hydroxyurea is permitted).\n* Concurrent malignancy of other organs that requires treatment.\n* Active cardiac disease, defined as one or more of the following:\n\n  1. History of uncontrolled or symptomatic angina pectoris;\n  2. Myocardial infarction within 6 months prior to study enrollment;\n  3. History of arrhythmia requiring medication or with clinically significant symptoms;\n  4. Uncontrolled or symptomatic congestive heart failure (\\> NYHA class 2).\n* Serious infectious diseases (e.g., active tuberculosis, pulmonary aspergillosis).\n* Patients deemed unsuitable for enrollment by the investigator.","14 Years",{"count":73,"type":22},320,[53],"This randomized, open label, multi arm phase II trial will evaluate the efficacy and safety of venetoclax based induction regimens of varying intensity (VA, VAM, or 2+5+V) versus standard 3+7 in fit patients aged ≥14 years with newly diagnosed AML. The trial is designed to select the optimal regimen as the experimental arm for a subsequent phase III randomized controlled trial.\n\nA total of 320 patients will be enrolled in this study，and segregated into four groups with 80 in each group. Patients who achieve CR\u002FCRi\u002FCRh after using different induction regimens will receive the same consolidation. Allogeneic hematopoietic stem cell transplantation is recommended for patients in the high-risk group or those with persist MRD positivity. After completion of the treatment phase, patients entered the follow-up period.",[77],"Acute Myeloid Leukemia (AML)",{"date":79,"type":33},"2026-08-10",{"date":81,"type":22},"2026-09-30",{"date":83,"type":22},"2029-09-30",{"name":39,"class":40},{"id":86,"slug":87,"hasResults":12,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":12,"sex":17,"minAge":92,"maxAge":18,"enrollmentInfo":93,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},"100650804","plasma-ctdna-monitoring-in-pediatric-acute-leukemia-100650804","NCT07751588","Plasma ctDNA Monitoring in Pediatric Acute Leukemia","A Retrospective-Prospective Observational Cohort Study of Peripheral Blood Plasma ctDNA Compared With Bone Marrow MFC-MRD, ddPCR, and RNA Sequencing in Pediatric Acute Leukemia","Inclusion Criteria:\n\n1. Patients diagnosed with pediatric acute leukemia, including acute lymphoblastic leukemia, acute myeloid leukemia, or mixed phenotype acute leukemia.\n2. Age younger than 18 years at diagnosis.\n3. Availability of peripheral blood plasma cfDNA\u002FctDNA testing data.\n4. Availability of clinical data and at least one corresponding bone marrow-based assessment, including MFC-MRD, ddPCR, RNA sequencing.\n5. For prospectively collected follow-up data or samples, written informed consent will be obtained from parents or legal guardians.\n6. For retrospectively collected data, consent procedures will follow the approval of the institutional ethics committee.\n\nExclusion Criteria:\n\n1. Patients without available peripheral blood plasma cfDNA\u002FctDNA data.\n2. Patients with insufficient clinical or laboratory data for analysis.\n3. Samples failing cfDNA\u002FctDNA quality control.\n4. Withdrawal of consent for prospective follow-up or additional sample collection.\n5. Patients judged by the investigator to be unsuitable for inclusion.","3 Years",{"count":7,"type":22},"OBSERVATIONAL","This retrospective-prospective observational cohort study aims to evaluate peripheral blood plasma circulating tumor DNA (ctDNA) dynamics in pediatric acute leukemia and compare ctDNA results with concurrent bone marrow multiparameter flow cytometry minimal residual disease (MFC-MRD), droplet digital PCR (ddPCR), and RNA sequencing findings. The study includes a retrospective cohort with available clinical and molecular data and a prospective cohort with serially collected peripheral blood and bone marrow samples at predefined treatment time points. The study will assess consistence between plasma ctDNA and conventional bone marrow-based assays, characterize longitudinal ctDNA dynamics, and explore the association between ctDNA patterns and relapse or survival outcomes.",[97,98],"Acute Myeloid Leukemia","Acute Lymphoblastic Leukemia",{"date":100,"type":33},"2026-08-07",{"date":102,"type":22},"2026-07-11",{"date":104,"type":22},"2027-12-31",{"name":39,"class":40},1,{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":23,"phases":117,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":106},"100650701","phase-2-bcmagprc5d-trispecific-antibody-treatment-for-newly-diagnosed-amyloidosis-al-004-100650701","NCT07751471","BCMA\u002FGPRC5D Trispecific Antibody Treatment for Newly Diagnosed Amyloidosis (AL-004)","A Single-arm Single-center Trial of BCMA\u002FGPRC5D Trispecific Antibody Treatment for Newly Diagnosed Amyloidosis (AL-004)","AL-004","Inclusion Criteria:\n\n1. Voluntarily provide written informed consent (ICF) prior to any study-specific procedures.\n2. Age ≥18 years, regardless of sex.\n3. Newly diagnosed primary systemic light-chain (AL) amyloidosis.\n4. Measurable disease at screening, defined as:\n\n   * Difference between involved and uninvolved serum free light chains (dFLC) ≥20 mg\u002FL; and\n   * Abnormal serum free light chain (FLC) ratio or other confirmed evidence of monoclonal light chain production.\n5. Eastern Cooperative Oncology Group (ECOG) performance status ≤2.\n6. Adequate organ function within 3 days before the first administration of the investigational product:\n\n   i. Absolute neutrophil count (ANC) ≥1.0 × 10⁹\u002FL, without treatment with granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 7 days, and without pegylated G-CSF within 14 days before dosing.\n\n   ii. Hemoglobin ≥75 g\u002FL without whole blood or red blood cell transfusion within 7 days before dosing.\n\n   iii. Platelet count ≥70 × 10⁹\u002FL without platelet transfusion, whole blood transfusion, or thrombopoietin receptor agonists within 7 days before dosing.\n\n   iv. Hepatic function:\n   * ALT ≤3 × upper limit of normal (ULN);\n   * AST ≤3 × ULN;\n   * Total bilirubin ≤2 × ULN. Participants with Gilbert syndrome may be enrolled if direct bilirubin is ≤2 × ULN.\n\n     v. Coagulation function:\n   * International normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤1.5 × ULN.\n\n   vi. Renal function:\n   * Estimated glomerular filtration rate (eGFR) ≥20 mL\u002Fmin\u002F1.73 m², calculated using the CKD-EPI equation.\n7. Male participants, women of childbearing potential, and their partners must agree to use effective contraception during study treatment and for at least 3 months after the last dose.\n8. Male participants must agree not to donate sperm from screening until 90 days after the last dose of study drug.\n9. Willing and able to comply with all study procedures and follow-up assessments.\n10. Women of childbearing potential must have a negative serum or urine β-human chorionic gonadotropin (β-hCG) pregnancy test at screening.\n\nExclusion Criteria:\n\n1. Non-AL amyloidosis, including hereditary amyloidosis or any other non-AL subtype.\n2. Symptomatic multiple myeloma.\n3. Grade \\>2 peripheral neuropathy or Grade ≥2 painful peripheral neuropathy at screening, regardless of current treatment.\n4. History of another malignancy within 5 years before enrollment, except AL amyloidosis.\n5. Prior anti-plasma cell therapy, including:\n\n   * Melphalan\n   * Cyclophosphamide\n   * Proteasome inhibitors\n   * Immunomodulatory drugs (IMiDs)\n   * Monoclonal antibodies\n   * Bispecific antibodies\n   * Trispecific antibodies\n   * Autologous stem cell transplantation\n   * Chimeric antigen receptor (CAR)-T cell therapy\n\n   Exceptions include:\n   1. Therapy for myeloproliferative neoplasms (e.g., hydroxyurea).\n   2. Chronic corticosteroid therapy (prednisone equivalent ≤20 mg\u002Fday) used for conditions such as adrenal insufficiency or rheumatoid arthritis.\n6. Known hypersensitivity, intolerance, or contraindication to the investigational BCMA\u002FGPRC5D trispecific antibody.\n7. Unstable or active cardiovascular or cerebrovascular disease, including:\n\n   1. Unstable angina, symptomatic myocardial ischemia, myocardial infarction, coronary revascularization, transient ischemic attack, subarachnoid hemorrhage, central nervous system hemorrhage, severe brain injury, stroke, seizure, deep vein thrombosis, or pulmonary embolism within 180 days before first dosing.\n   2. Hospitalization for cardiovascular disease within 4 weeks before enrollment in participants with congestive heart failure.\n   3. Heart failure primarily caused by ischemic heart disease or uncorrected valvular disease rather than AL cardiac amyloidosis.\n   4. New York Heart Association (NYHA) Class IV heart failure.\n   5. History of sustained ventricular tachycardia or ventricular fibrillation, or atrioventricular (AV) node or sinoatrial (SA) node dysfunction requiring but not receiving a pacemaker or implantable cardioverter-defibrillator (ICD). Participants with implanted pacemakers or ICDs are eligible.\n   6. Corrected QT interval (QTcF) \\>500 ms (participants with implanted pacemakers are exempt).\n   7. Supine systolic blood pressure \\\u003C90 mmHg.\n   8. Any other cardiovascular or cerebrovascular condition considered by the investigator to make study participation inappropriate.\n8. Symptomatic interstitial lung disease or noninfectious pneumonitis (e.g., pneumoconiosis, radiation pneumonitis, or drug-induced pneumonitis), or pulmonary impairment requiring supplemental oxygen.\n9. Requirement for oral anti-infective therapy within 2 weeks before first dose or intravenous systemic anti-infective therapy within 4 weeks before first dose.\n10. Active infection, including:\n\n    1. Active hepatitis B infection (HBV DNA positive);\n    2. Active hepatitis C infection (HCV RNA positive in participants with positive anti-HCV antibody);\n    3. Human immunodeficiency virus (HIV) infection;\n    4. Active or latent syphilis (positive Treponema pallidum antibody);\n    5. Active pulmonary tuberculosis identified within 3 months before first dose or during screening.\n11. Pregnant or breastfeeding women.\n12. Any condition that may interfere with compliance with the study protocol (e.g., substance abuse, dementia, altered mental status), interfere with study procedures or interpretation of results, or pose unacceptable risk according to investigator judgment.\n13. Active gastrointestinal disorders that impair swallowing or are likely to interfere with study drug absorption.\n14. Major surgery within 2 weeks before enrollment, incomplete recovery from surgery, or planned major surgery during study participation. Kyphoplasty and vertebroplasty are not considered major surgery. Procedures under local anesthesia are permitted.\n15. Receipt of a live attenuated vaccine within 4 weeks before the first study drug administration.\n16. Contraindication to any required concomitant medication or supportive therapy.\n17. Any disease or medical condition that may interfere with study procedures.\n18. Unwillingness or inability to comply with the study protocol.\n19. Any other condition that, in the investigator's judgment, makes the participant unsuitable for study participation.",{"count":116,"type":22},20,[53],"Systemic light-chain (AL) amyloidosis is a plasma cell disorder characterized by the production of misfolded immunoglobulin light chains that deposit in organs and lead to progressive organ dysfunction. Although daratumumab-based therapy has improved outcomes, a substantial proportion of patients fail to achieve deep hematologic responses.\n\nThis is a prospective, single-arm, single-center clinical study evaluating the safety and efficacy of the BCMA\u002FGPRC5D\u002FCD3 trispecific antibody QLS4131 in patients with newly diagnosed systemic AL amyloidosis.",[120],"AL Amyloidosis",[122,123,124,125],"QLS4131","Systemic Light Chain Amyloidosis","BCMA\u002FGPRC5D\u002FCD3 trispecific antibody","Plasma cell disorder",{"date":100,"type":33},{"date":128,"type":22},"2026-07-20",{"date":130,"type":22},"2028-12-31",{"name":39,"class":40},{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":12,"sex":17,"minAge":71,"maxAge":139,"enrollmentInfo":140,"targetDuration":4,"studyType":23,"phases":142,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":147,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":106},"100631050","pediatric-inspired-regimen-combined-with-venetoclax-and-immunotherapy-for-adult-ph-negative-acute-lymphoblastic-leukemia-100631050","NCT07495631","Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia","A Prospective Cohort Study of a Pediatric-Inspired Chemotherapy Regimen Combined With Venetoclax and Immunotherapy for the Treatment of Adult Ph-Negative Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* Newly diagnosed, previously untreated (except prednisone\u002Fhydroxyurea) Ph-negative ALL\n* Age ≥14 years, ≤60 years\n* ECOG performance status ≤2\n* Adequate organ function (liver, kidney, cardiac)\n* For patients of childbearing potential: use of effective contraception\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Burkitt leukemia\u002Flymphoma\n* Acute leukemia of ambiguous lineage\n* Pregnancy or lactation\n* Severe uncontrolled active infection\n* History of pancreatitis\n* Uncontrolled diabetes (HbA1c \\>7.5%)\n* Active gastrointestinal bleeding within 6 months\n* Arterial\u002Fvenous thrombosis within 6 months\n* Known HIV positivity\n* Severe psychiatric illness hindering compliance\n* Any other condition deemed unsuitable by the investigator","60 Years",{"count":141,"type":22},43,[25],"This is a prospective, open-label, non-randomized cohort study evaluating the efficacy and safety of a pediatric-inspired chemotherapy regimen (IH-2014 based) combined with venetoclax and immunotherapy in adult patients with newly diagnosed Ph-negative Acute Lymphoblastic Leukemia (ALL). Patients aged ≥14years,≤60 years will be enrolled. Treatment includes induction, consolidation, early intensification, delayed intensification, and maintenance phases. The use and number of cycles of immunotherapy will be based on patient preference. The primary endpoint is Event-Free Survival (EFS) and MRD-negative CR rates after induction therapy(by flow cytometry and NGS). Secondary endpoints include Complete Remission (CR) rate, MRD-negative CR rates at 12 weeks (by flow cytometry and NGS), Overall Survival (OS), Relapse-Free Survival (RFS), and cumulative relapse rate.",[145],"Acute Lymphoblastic Leukemia, Adult","RECRUITING",{"date":79,"type":33},{"date":149,"type":33},"2026-04-08",{"date":151,"type":22},"2030-03-01",{"name":39,"class":40},{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":17,"minAge":71,"maxAge":160,"enrollmentInfo":161,"targetDuration":4,"studyType":23,"phases":163,"briefSummary":164,"conditions":165,"keywords":4,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":167,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":106},"100630639","venetoclax-azacitidine-and-liposomal-mitoxantrone-for-newly-diagnosed-aml-100630639","NCT07490288","Venetoclax, Azacitidine and Liposomal Mitoxantrone for Newly Diagnosed AML","A Single-Arm, Open-Label Study of Venetoclax, Azacitidine, and Liposomal Mitoxantrone (VAM) as Induction Therapy in Newly-diagnosed Adult Patients With Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n* Patients diagnosed with AML according to the WHO (2022) or ICC criteria, or with MDS\u002FAML as defined by ICC (with 10%-20% blasts in the bone marrow)\n* Age ≥ 14 years, male or female.\n* Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2.\n* Meet the following laboratory requirements (tests must be performed within 7 days prior to treatment):\n\n  i. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) for the corresponding age group.\n\nii. AST and ALT ≤ 2.5 times ULN for the corresponding age group. iii. Serum creatinine \\\u003C 1.5 times ULN for the corresponding age group. iv. Cardiac enzymes \\\u003C 2 times ULN for the corresponding age group. v. Left ventricular ejection fraction (LVEF) within the normal range as measured by echocardiography (ECHO).\n\nExclusion Criteria:\n\n* Acute promyelocytic leukemia with PML::RARA fusion gene.\n* Acute myeloid leukemia with RUNX1::RUNX1T1 fusion gene.\n* Acute myeloid leukemia with BCR::ABL1 fusion gene.\n* Previously treated patients (defined as having received prior induction chemotherapy for AML\u002FMDS; prior use of cytoreductive agents like hydroxyurea is allowed).\n* Concurrent active malignancy of other organs (requiring treatment).\n* Active cardiac disease, defined as one or more of the following:\n\n  i. History of uncontrolled or symptomatic angina. ii. Myocardial infarction within 6 months prior to study enrollment. iii. History of clinically significant arrhythmia requiring medication or causing severe symptoms.\n\niv. Uncontrolled or symptomatic congestive heart failure (\\> New York Heart Association \\[NYHA\\] Class 2).\n\n* Active, uncontrolled infectious diseases (e.g., untreated tuberculosis, pulmonary aspergillosis).\n* Any other condition that, in the opinion of the investigator, makes the patient unsuitable for study participation.","100 Years",{"count":162,"type":22},27,[25],"This is a single-arm, open-label clinical trial evaluating the safety and preliminary efficacy of a novel induction regimen combining Venetoclax, Azacitidine, and Liposomal Mitoxantrone (VAM) in patients with newly diagnosed Acute Myeloid Leukemia (AML) who are eligible for intensive chemotherapy.\n\nThe study plans to enroll 27 participants. Patients will receive VAM induction therapy, followed by three cycles of intermediate-dose cytarabine consolidation. Allogeneic hematopoietic stem cell transplantation is recommended for high-risk or MRD-positive patients in remission.",[166],"AML",{"date":100,"type":33},{"date":169,"type":33},"2026-05-08",{"date":171,"type":22},"2029-03-01",{"name":39,"class":40},{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":23,"phases":182,"briefSummary":183,"conditions":184,"keywords":186,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":190,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":194,"locationsCount":106},"100624424","phase-2-mrd-guided-bcmacd3-bispecific-antibody-treatment-after-stem-cell-transplant-for-newly-diagnosed-multiple-myeloma-100624424","NCT07409454","MRD-Guided BCMA\u002FCD3 Bispecific Antibody Treatment After Stem Cell Transplant for Newly Diagnosed Multiple Myeloma","A Prospective, Single-Arm Clinical Trial of MRD-Guided BCMA\u002FCD3 Bispecific Antibody as Maintenance Therapy After Autologous Hematopoietic Stem Cell Transplantation in Newly Diagnosed Multiple Myeloma","CAREMM-007","Inclusion Criteria:\n\n1. Be able to understand and voluntarily signs the informed consent form (ICF).\n2. Age ≥ 18 years.\n3. Newly diagnosed multiple myeloma according to the International Myeloma Working Group (IMWG) criteria.\n4. MRD positivity (≥10-⁵) detected by EuroFlow.\n5. Previous therapy limited to first-line treatment only, including: (1) Induction therapy with a 3- or 4-drug regimen containing a proteasome inhibitor and\u002For an immunomodulatory drug and\u002For an anti-CD38 monoclonal antibody; (2) Single or tandem autologous stem cell transplantation (ASCT); (3) Up to 2-4 cycles of consolidation therapy post-ASCT are permitted, with the total number of induction plus consolidation cycles not exceeding 8.\n6. Completion of ASCT within ≤12 months from the start of induction therapy; and ≤6 months from the most recent ASCT at enrollment (≤7 months if consolidation therapy was administered).\n7. No prior maintenance therapy.\n8. Achieved at least a partial response (≥PR) according to the IMWG 2016 response criteria.\n9. Presence of measurable disease at diagnosis.\n\nExclusion Criteria:\n\n1. Prior treatment with genetically modified adoptive cellular therapy.\n2. History of allogeneic stem cell transplantation or solid organ transplantation.\n3. Disease progression prior to enrollment (per IMWG 2016 response criteria), or presence of plasma cell leukemia, Waldenström macroglobulinemia, POEMS syndrome, or light-chain amyloidosis not attributable to symptomatic multiple myeloma.\n4. Central nervous system involvement.",{"count":116,"type":22},[53],"This is a prospective, single-arm clinical study designed to evaluate the efficacy and safety of the BCMA\u002FCD3 bispecific antibody (CM336) as maintenance therapy after autologous hematopoietic stem cell transplantation in patients with newly diagnosed multiple myeloma.",[185],"Multiple Myeloma",[187,188,189],"BCMA\u002FCD3 bispecific antibody","multiple myeloma","CM336",{"date":100,"type":33},{"date":192,"type":33},"2026-07-07",{"date":130,"type":22},{"name":39,"class":40},{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":17,"minAge":71,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":23,"phases":204,"briefSummary":205,"conditions":206,"keywords":208,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":213,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":106},"100607452","metformin-inhibits-dnmt3a-clonal-hematopoiesis-in-acute-leukemia-100607452","NCT07188740","Metformin Inhibits DNMT3A Clonal Hematopoiesis in Acute Leukemia","Metformin Inhibits DNMT3A Clonal Hematopoiesis in Acute Leukemia: A Single-Arm Clinical Study","Inclusion Criteria:\n\n* Patients diagnosed with acute leukemia based on bone marrow morphology, immunology, and genetics, per WHO 2022 or ICC criteria.\n* Patients in complete remission follow-up phase with DNMT3A R882 mutation clonal hematopoiesis, VAF ≥5%.\n* Age ≥14 years, any gender\n* Laboratory requirements (within 7 days before treatment):\n\n  * Total bilirubin ≤1.5 × upper limit of normal (ULN) for age.\n  * AST and ALT ≤2.5 × ULN for age.\n  * Serum creatinine \\\u003C2 × ULN for age.\n  * Cardiac enzymes \\\u003C2 × ULN for age.\n  * Ejection fraction within normal range by echocardiogram (ECHO).\n* Signed informed consent: By patient (≥18 years) or legal guardian\u002Frelative (\\\u003C18 years or if beneficial for condition).\n\nExclusion Criteria:\n\n* Patients with diabetes receiving other medications\n* Known allergy to metformin\n* Deemed unsuitable by investigator",{"count":203,"type":22},32,[52],"This is a prospective, single-arm clinical study evaluating the efficacy and safety of metformin in inhibiting DNMT3A R882-driven clonal hematopoiesis (CH) in patients with acute leukemia (AL) who are in remission and under follow-up. Patients with DNMT3A R882 mutation (VAF ≥5%) will receive oral metformin for 6 months, with dosage gradually increased to 2000 mg\u002Fday. The primary endpoint is the proportion of patients with effective decline in DNMT3A R882 mutation VAF at 6 months. Secondary endpoints include VAF decline at 3 months, relapse-free survival (RFS) at 6 and 12 months, overall survival (OS), cumulative incidence of relapse (CIR), cumulative remission-phase mortality, and adverse event rates. Planned enrollment: 32 participants.",[207],"DNMT3A Gene Mutation",[209,210,211,212],"CHIP","acute leukemia","Metformin","DNMT3A",{"date":79,"type":33},{"date":215,"type":22},"2026-08-30",{"date":217,"type":22},"2029-08-30",{"name":39,"class":40},{"id":220,"slug":221,"hasResults":12,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":12,"sex":17,"minAge":71,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":23,"phases":228,"briefSummary":229,"conditions":230,"keywords":232,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":234,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":106},"100603018","mrd-positive-aml-clinical-study-100603018","NCT07131059","MRD-positive AML Clinical Study","MRD-positive AML: a Prospective, Single-arm, Multicenter Platform Clinical Study","Inclusion Criteria:\n\n* AML (non-M3) compliant with WHO (2016) standards;\n* In morphological complete remission.\n* Mrd-positive patients: including bone marrow flow cytometry, PCR quantification of NPM1 mutations, PCR quantification of fusion genes (RUNX 1-RUNX1T1, CBFB-MYH11 and DEK-NUP214), or NGS detection of FLT3 mutation positive.\n* Age over 14 years old, male or female. Informed consent must be signed prior to the commencement of all specific study procedures, and for those 14 years of age and older, informed consent must be signed by the patient or an immediate family member. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the condition, the informed consent shall be signed by the legal guardian or the patient's immediate family.\n\nExclusion Criteria:\n\n* Patients who intend to undergo hematopoietic stem cell transplantation within 4 weeks\n* The diagnosis is APL\n* Those who were not considered suitable for inclusion by the researchers.",{"count":227,"type":22},537,[25],"This clinical trial is a platform-type clinical study intended to investigate the efficacy and safety of MRD-positive acute myeloid leukemia patients after comprehensive treatment, which includes but is not limited to the following drugs and protocols: Chemotherapy, small molecule targeted drugs, demethylation drugs, liposome drugs and the combination of these drugs to form a combination of treatment regimen, the specific treatment regimen will be updated according to the results of this trial and the latest research progress at home and abroad.",[231],"AML, Adult",[233],"Measurable Residual Disease",{"date":79,"type":33},{"date":236,"type":33},"2024-05-11",{"date":238,"type":22},"2028-10-30",{"name":39,"class":40},{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":12,"sex":17,"minAge":71,"maxAge":139,"enrollmentInfo":247,"targetDuration":4,"studyType":23,"phases":249,"briefSummary":251,"conditions":252,"keywords":4,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":254,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":106},"100573301","phase-3-standard-dose-vs-intermediate-dose-cytarabine-induction-in-the-treatment-of-acute-myeloid-leukemia-with-runx1-runx1t1-100573301","NCT06744504","Standard-dose vs Intermediate-dose Cytarabine Induction in the Treatment of Acute Myeloid Leukemia With RUNX1-RUNX1T1","Anthracycline-based Standard-dose vs Intermediate-dose Cytarabine Induction in the Treatment of Acute Myeloid Leukemia With RUNX1-RUNX1T1: a Prospective, Randomized, Controlled Phase III Clinical Trial","Inclusion Criteria:\n\n1. AML conforming to WHO (2022) or ICC standards\n2. Possessing the RUNX1::RUNX1T1 fusion gene\n3. Age ranging from 14 to 60 years old, regardless of gender.\n4. The performance status assessment of the Eastern Cooperative Oncology Group (ECOG-PS) being 0 - 2.\n5. Meeting the requirements of the following laboratory examination indicators (conducted within 7 days before treatment):\n\n1\\) Total bilirubin ≤ 1.5 times the upper limit of the normal value for the same age group; 2) AST and ALT ≤ 2.5 times the upper limit of the normal value for the same age group; 3) Serum creatinine \\\u003C 2 times the upper limit of the normal value for the same age group; 4) Cardiac enzymes \\\u003C 2 times the upper limit of the normal value for the same age group; 5) The cardiac ejection fraction determined by echocardiography (ECHO) \\> 50%. An informed consent form must be signed before the commencement of all specific research procedures, either by the patient themselves or their immediate relatives. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the disease, the informed consent form shall be signed by the legal guardian or the immediate relatives of the patient.\n\nExclusion Criteria:\n\n1. Acute promyelocytic leukemia accompanied by PML-RARA fusion gene.\n2. Acute myeloid leukemia featuring BCR-ABL fusion gene.\n3. Patients undergoing retreatment (but can receive cytoreductive therapy with hydroxyurea and cytarabine).\n4. Individuals concurrently having malignant tumors in other organs (requiring treatment).\n5. Active cardiac disorders, defined as one or more of the following:\n\n1\\) A history of uncontrolled or symptomatic angina pectoris; 2) Myocardial infarction less than 6 months from study enrollment; 3) A history of significant arrhythmia requiring medication or presenting with severe clinical symptoms; 4) Uncontrolled or symptomatic congestive heart failure (\\> NYHA Class 2)\n\n6\\. Severe infectious diseases (untreated tuberculosis, pulmonary aspergillosis).\n\n7\\. Individuals deemed ineligible for enrollment by the investigator.",{"count":248,"type":22},284,[250],"PHASE3","Leukemia is one of the common malignant tumors that threaten human health. Although the efficacy of AML treatment has improved significantly in recent years, it remains one of the major diseases threatening human health. Current research on AML treatment mainly has two directions. One is the addition of new targeted therapy drugs, and the other research direction is to enhance the intensity of AML chemotherapy, including the use of large doses of anthracycline drugs or the use of high-dose cytarabine treatment.\n\nSince the 1990s, induction remission has been achieved by using anthracyclines in combination with high-dose cytarabine. The ECOG (Eastern Cooperative Oncology Group) contends that high-dose induction chemotherapy fails to enhance the bone marrow remission rate but elevates the chemotherapy-related mortality rate. Bradstock and the Australian Group also noted that although it does not increase the bone marrow remission rate, it can result in longer survival time and disease-free survival time. The clinical study from EORTC-GIMEMA AML-12 discovered that AML patients under the age of 45 could benefit from induction therapy incorporating high-dose cytarabine. In our previous randomized controlled clinical trials, it was found that the HAD and DA regimens containing intermediate-dose cytarabine could enhance the complete remission rate and improve the overall survival of adult AML. However, the degree of benefit varies among different AML subgroups.\n\nThe abnormalities of RUNX1-RUNX1T1 and CBFβ-MYH11 respectively involve a subunit of CBF (core binding factor), thus the two are collectively called CBF leukemia. Previous retrospective studies show that this type of leukemia benefits from intensified treatment regimens such as FLAG. However, at present, there is a lack of prospective randomized controlled clinical studies to confirm this. Therefore, in this study, we intend to further verify through a prospective randomized controlled clinical trial whether the induction treatment regimen containing intermediate-dose cytarabine can improve the long-term efficacy of adult RUNX1-RUNX1T1 acute myeloid leukemia.",[166,253],"RUNX1-RUNX1T1 Fusion Protein Expression",{"date":100,"type":33},{"date":256,"type":33},"2025-01-10",{"date":258,"type":22},"2029-12-01",{"name":39,"class":40},{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":266,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":17,"minAge":71,"maxAge":268,"enrollmentInfo":269,"targetDuration":4,"studyType":23,"phases":271,"briefSummary":272,"conditions":273,"keywords":274,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":277,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":106},"100556756","intermediate-dose-had-regimen-for-cebpa-double-mutated-aml-100556756","NCT06529250","Intermediate-dose HAD Regimen for CEBPA Double-mutated AML","A Multicenter, Randomized, Controlled Clinical Trial of Intermediate-dose HAD Regimen for CEBPA Double-mutated Acute Myeloid Leukemia","HADCEBPA2023","Inclusion Criteria:\n\n1. AML diagnosed according to WHO-2022 classification with recurrent CEBPA mutations and containing mutation in the bZIP domain.\n2. Older than 14 years old and younger than 55 years old\n3. Male or female.\n4. The Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of AML patients were 0-2 points.\n5. Meet the following laboratory tests (performed within 7 days prior to treatment) 1) Total bilirubin ≤ 1.5 times of the upper limit of normal value (same age); 2) AST and ALT≤ 2.5 times of the upper limit of normal value (same age); 3) Blood creatinine \\\u003C 2 times of the upper limit of normal value (same age); 4) Myocardial enzymes \\\u003C 2 times of the upper limit of normal value (same age); 5) Echocardiography (ECHO) was performed to determine the ejection fraction of the heart within the normal range.\n\nExclusion Criteria:\n\n1. Patients who have previously received induction chemotherapy, regardless of efficacy.\n2. Simultaneously suffering from malignant tumors of other organs and requiring treatment).\n3. Pregnant or lactating women. Male or female patients participating in the trial must take contraceptive measures during the trial treatment period.\n4. Active heart disease, defined as one or more of the following:1) Have a history of uncontrolled or symptomatic angina pectoris;2) Myocardial infarction less than 6 months prior to enrollment in the study;3) A history of arrhythmia requiring medication treatment or severe clinical symptoms;4) Uncontrolled or symptomatic congestive heart failure (\\> NYHA grade 2);5) The ejection fraction is below the lower limit of the normal range.\n5. Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis).\n6. Those who were not considered suitable for inclusion by the researchers.","54 Years",{"count":270,"type":22},148,[25],"AML is highly heterogeneous in pathogenesis, and CEBPA double-mutated (CEBPAdm) AML is a common type of leukemia in China. Currently, no targeted therapies for CEBPAdm, and chemotherapy and transplantation are still the treatment options for CEBPA double-mutated AML. At present, the \"3+7\" treatment induction regimen of cytarabine combined with anthracyclines is still the first-line recommended regimen. In our retrospective study, the intermediate dose HAD regimen produced a 3-year RFS of 84.7% and a 3-year OS of 92.8% in CEBPAdm AML. Therefore, this project intends to confirm the efficacy of intermediate-dose HAD in the treatment of CEBPA double-mutated AML is superior to the conventional treatment regimen through the multi-center RCT study.",[166],[166,275,276],"CEBPA double-mutated","treatment",{"date":79,"type":33},{"date":279,"type":33},"2024-08-13",{"date":281,"type":22},"2029-09-01",{"name":39,"class":40},{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":23,"phases":291,"briefSummary":292,"conditions":293,"keywords":296,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":297,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":106},"100536493","multicenter-platform-type-clinical-study-of-refractoryrecurrent-acute-myeloid-leukemia-100536493","NCT06265545","Multicenter, Platform-type Clinical Study of Refractory\u002FRecurrent Acute Myeloid Leukemia","Inclusion Criteria:\n\n* 1\\. Patients with acute myeloid leukemia (except for acute promyelocytic leukemia) diagnosed by bone marrow cell morphology, immunology and genetics above are classified according to the French-British-American Collaboration diagnostic criteria (FAB criteria) and the World Health Organization diagnostic criteria (WHO2016 criteria).\n\n  2\\. Meet criteria for refractory\u002Frecurrent AML (except APL). The recurrence was morphological recurrence, excluding molecular recurrence. Except for simple extramedullary leukemia.\n\n  3\\. Age and gender are not limited. 4. Informed consent must be signed before the start of the study procedure, and the informed consent must be signed by the patient himself or his immediate family if he is 18 years old and above; For young patients under the age of 18, the legal guardian shall sign the informed consent. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the condition, the informed consent shall be signed by the legal guardian or the patient's immediate family.\n\nExclusion Criteria:\n\n1. Concurrent malignant tumors of other organs (patients requiring treatment).\n2. Participants considered unsuitable for inclusion by the researchers.",{"count":290,"type":22},458,[25],"To study the optimal therapeutic strategies for salvage treatment of refractory\u002Frelapsed AML, and to clarify the effectiveness and safety of various salvage treatment options. A prospective, multicenter, platform-type study was conducted to explore the overall response rate, tolerability, and survival of patients with R\u002FR AML with different treatment regimens.",[166,294,295],"Refractory","Relapsed",[166,294,295],{"date":100,"type":33},{"date":299,"type":33},"2024-02-22",{"date":301,"type":22},"2028-06-30",{"name":39,"class":40},{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":310,"enrollmentInfo":311,"targetDuration":4,"studyType":23,"phases":312,"briefSummary":313,"conditions":314,"keywords":4,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":315,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":106},"100487844","phase-1-asct-in-combination-with-c-car088-for-treating-patients-with-ultra-high-risk-multiple-myeloma-mm-100487844","NCT05632380","ASCT in Combination With C-CAR088 for Treating Patients With Ultra High-risk Multiple Myeloma (MM)","The Safety and Efficacy of Autologous Hematopoietic Stem Cell Transplantation (ASCT) in Combination With C-CAR088, an Autologous BCMA CAR-T Cell Product, for Treating Patients With Ultra High-risk Multiple Myeloma","Inclusion Criteria:\n\n* Transplantation eligible patients, male or female, aged 18 to 70 years\n* Ultra high risk multiple myeloma, defined as failed or unsatisfied responses to front line VRD-based treatment with or without the presence of multiple high-risk cytogenetic features\n* Adequate liver, renal, bone marrow, and heart function\n* Eastern Cooperative Oncology Group (ECOG) Performance status 0-1.\n* Male and female of reproductive potential must agree to use birth control during the study.\n\nExclusion Criteria:\n\n* Known allergies to the components or excipients of the C-CAR088 cell product\n* Prior allogenic HSCT, or ASCT\n* CNS involvement\n* Stroke or convulsion history within 6 months prior to signing ICF\n* Autoimmune disease, immunodeficiency or disease requiring immunosuppressants treatment\n* Uncontrolled active infection; active HBV, HCV infection; HIV or syphilis Infection\n* Severe heart, liver, renal or metabolism disease\n* Inadequate wash-out time for previous anti-tumor treatments prior to apheresis\n* Previous CAR-T cell treatment, genetically modified T-cell therapies or BCMA-directed treatment history\n* History or current evidence of any condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the patient's safe participation and compliance in the trial","70 Years",{"count":116,"type":22},[52,53],"This is a phase I\u002FII, single-arm, open-lable study of autologous stem cell transplantation in combination with C-CAR088, an autologous BCMA CAR-T cell product, for patients with ulta high-risk multiple myeloma, defined as failed or unsatisfied responses to front line VRD-based treatment with or without the presence of multiple high-risk cytogenetic features.",[185],{"date":100,"type":33},{"date":317,"type":33},"2022-07-14",{"date":319,"type":22},"2026-10-30",{"name":39,"class":40},{"id":322,"slug":323,"hasResults":12,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":4,"eligibilityCriteria":327,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":328,"enrollmentInfo":329,"targetDuration":4,"studyType":23,"phases":331,"briefSummary":332,"conditions":333,"keywords":336,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":346,"leadSponsor":347,"locationsCount":4},"100648633","phase-1-shr2554-plus-liposomal-mitoxantrone-as-first-line-treatment-for-peripheral-t-cell-lymphoma-ptcl-100648633","NCT07725705","SHR2554 Plus Liposomal Mitoxantrone as First-line Treatment for Peripheral T-cell Lymphoma (PTCL)","An Open-label, Multicenter, Phase Ib\u002FII Exploratory Clinical Study of EZH2 Inhibitor SHR2554 in Combination With Liposomal Mitoxantrone for the First-line Treatment of Peripheral T-cell Lymphoma","Inclusion Criteria:\n\n1. Age ≥18 years old,regardless of gender;\n2. Centrally confirmed histopathological\u002Fcytologic diagnosis of PTCL with the following subtypes:Peripheral T-cell lymphoma, not otherwise specified (PTCL, NOS);Follicular helper T (TFH) cell lymphoma of lymph nodes, including angioimmunoblastic, follicular, NOS; Enteropathy-associated T-cell lymphoma(EATL); Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL)and any other PTCL subtypes deemed by the investigator to be eligible for inclusion.\n3. No prior anti-tumor therapy.\n4. There must be at least one measurable or evaluable lesion that meets the Lugano 2014 criteria for lymphoma: Measurable lesion: Nodal lesions with major diameter greater than 1.5cm and minor diameter greater than 1.0cm as assessed by PET\u002FCT or Computed Tomography (CT) and\u002For Magnetic Resonance Imaging (MRI); Or the length of extranodal lesions \\>1.0cm; 2)Evaluable lesions: PET-CT showed increased uptake in lymph nodes or extranodal regions (higher than liver) and imaging features consistent with lymphoma;\n5. ECOG performance status score: 0-2;\n6. Expected survival time ≥3 months;\n7. Have adequate organ and bone marrow functiont;\n8. No concurrent hemophagocytic lymphohistiocytosis (HLH). If a patient has clinically diagnosed HLH, enrollment eligibility will be determined by the investigator based on an evaluation of the patient's general physical condition following targeted anti-HLH therapy.\n9. Women of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose of medication; Effective contraception should be used from the time of informed consent until 6 months after the last dose of study drug.\n10. Capable of understanding the study procedures and voluntarily signing a written informed consent form (ICF).;\n\nExclusion Criteria:\n\n1. Prior treatment with epigenetic agents before enrollment;\n2. Patients with a history of severe cardiac disease, history of radiation therapy to the mediastinal\u002Fpericardial region, cumulative anthracycline dose \\> 550 mg (doxorubicin equivalent), prior use of mitoxantrone, baseline left ventricular ejection fraction (LVEF) \\\u003C 50%, or history of exposure to other cardiotoxic drugs;\n3. History of other primary aggressive malignancies that are not in remission, or have been in remission for less than 3 years;\n4. Primary central nervous system (CNS) lymphoma or secondary CNS involvement.\n5. Known allergy or hypersensitivity to the study drugs or their related metabolites;\n6. Currently participating in another clinical study, or less than 4 weeks elapsed from the end of treatment in a previous clinical study to the planned start of study treatment;\n7. Pregnant or lactating women;\n8. Active infections;\n9. Medical History and Concurrent Conditions;\n10. History of Human Immunodeficiency Virus (HIV) infection and\u002For Acquired Immunodeficiency Syndrome (AIDS);\n11. Patients with mental disorders or those unable to provide informed consent\n12. Any other condition deemed by the investigator to be unsuitable for study enrollment;","80 Years",{"count":330,"type":22},44,[52,53],"This is a single-arm, multicenter, Phase Ib\u002FIIa study designed to explore the efficacy and safety of SHR2554 in combination with liposomal mitoxantrone for the treatment of patients with treatment-naive peripheral T-cell lymphoma (PTCL). The study is divided into a Phase Ib safety lead-in phase and a Phase IIa dose expansion phase.",[334,335],"PTCL","First Line Treatment",[337,338,339,340,341],"EZH2 inhibitor","SHR2554","Liposomal Mitoxantrone","First-line Treatment of PTCL","Zeprumetostat","2026-07-21",{"date":344,"type":33},"2026-07-24",{"date":35,"type":22},{"date":151,"type":22},{"name":39,"class":40},{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":4,"eligibilityCriteria":354,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":355,"targetDuration":4,"studyType":23,"phases":357,"briefSummary":358,"conditions":359,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":361,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":4},"100648552","phase-3-a-study-of-injectable-blb101-and-blincyto-in-adult-participants-with-rr-cd19-b-all-100648552","NCT07723911","A Study of Injectable BLB101 and Blincyto® in Adult Participants With R\u002FR CD19+ B-ALL","A Randomized, Double-Blind, Positive-Controlled, Multicenter Clinical Study to Compare the Similarities in Pharmacokinetics, Efficacy, Safety and Immunogenicity Between BLB101 and Blincyto® in Adult Participants With R\u002FR CD19+ B-ALL","Inclusion Criteria:\n\nParticipants must meet all of the following inclusion criteria to be included in this study:\n\n1. Before the trial began, the trial details were known, and the participant understood and voluntarily signed the Informed Consent Form (ICF);\n2. Age ≥ 18 years old;\n3. Confirmed as Philadelphia chromosome (Ph) negative and CD19 positive relapsed\u002Frefractory B-ALL (must meet: ① Through morphological and local flow cytometry immunophenotype assessment, there are expressed CD19 primitive immature cells in peripheral blood or bone marrow, confirming the current state of relapse, and there are relevant medical records to support; ② The proportion of primitive cells in the bone marrow is greater than 5% (measured by morphology); ③ Chromosome karyotype analysis or FISH analysis or PCR or NGS confirms Ph-negative), the Ph status needs to be reconfirmed before enrollment;\n4. ECOG ≤ 2 points;\n5. The number of previous treatment lines is 1 to 2, and it meets the definition of relapse or refractory (any of the following conditions can be included in the group: ① Late relapse: Reversal after achieving remission with previous treatment and duration ≥ 12 months; ② Early relapse: Remission achieved with previous treatment and duration \\\u003C 12 months; ③ Refractory: Failure to achieve remission during the first induction or salvage treatment; ④ Recurrence after transplantation: Recurrence at any time after hematopoietic stem cell transplantation);\n6. Weight ≥ 45 kg;\n7. Expected survival period ≥ 3 months;\n8. Organ function requirements: Liver and kidney function: ALT\u002FAST ≤ 3 times the upper limit of normal (ULN), total bilirubin ≤ 1.5 × ULN; Creatinine clearance rate ≥ 60 mL\u002Fmin; Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%, no severe arrhythmia;\n9. Participants need to have recovered to ≤ Grade 1 toxicity from previous treatments (according to CTCAE V6.0 standards), excluding hematological toxicity;\n10. Participants need to meet the washout period from the first administration of anti-tumor treatment: a) At least 2 weeks after the end of cytotoxic chemotherapy drugs treatment; b) At least 5 half-lives after non-cytotoxic drugs (if the duration of 5 half-lives exceeds 4 weeks, the washout period is still counted as 4 weeks), for drugs with an unclear half-life, it is counted as more than 4 weeks; c) At least 2 weeks after anti-tumor traditional Chinese medicine treatment; d) At least 3 months after CAR-T treatment; e) At least 5 half-lives after antibody drugs and antibody conjugate drugs (ADC); (if the duration of 5 half-lives exceeds 3 months, the washout period is still counted as 3 months);\n11. According to the investigator's judgment, the participant's compliance can reach understanding and following the plan for visits, treatment, laboratory tests, and other research procedures, and is expected to receive the study drug for ≥ 1 cycle;\n12. For female participants with reproductive capacity: Agree to take effective contraceptive measures from the start of signing the informed consent form until 6 months after the last administration of the trial drug, and agree not to donate eggs. For male participants: Agree to take effective contraceptive measures from the start of signing the informed consent form until 6 months after the last administration of the trial drug, and agree not to donate sperm. -\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria are not eligible to be included in this study:\n\n1. Participants with negative CD19 in ALL;\n2. Participants with Ph-positive ALL or mixed phenotype;\n3. Pregnant or lactating women;\n4. Active central nervous system (CNS) leukemia (cerebrospinal fluid white blood cells ≥ 5\u002FμL and leukemia cells are observed); those with a history of CNS disease who have received effective treatment and achieved remission are excluded;\n5. Participants with Burkitt lymphoma\u002Fleukemia;\n6. Participants with isolated extramedullary disease recurrence and active ALL in the testicles;\n7. Participants who have received targeted CD19 anti-tumor therapy before and have a proportion of CD19-positive leukemia cells \\\u003C 50%;\n8. Participants who have received at least 28 days of targeted CD19 bispecific antibody treatment and have been ineffective (ineffectiveness is defined as the failure to achieve CR or CRh or CRi or MLFS in the efficacy evaluation);\n9. Participants who have received at least 1 time of targeted CD19 CAR-T infusion and have been ineffective (ineffectiveness is defined as the failure to achieve CR or CRh or CRi or MLFS in the efficacy evaluation);\n10. Participants who have received targeted CD19 bispecific antibody treatment and have achieved CR or CRh or CRi or MLFS but have relapsed within ≤ 6 months;\n11. Participants who have received targeted CD19 CAR-T treatment and have achieved CR or CRh or CRi or MLFS but have relapsed within ≤ 12 months;\n12. Participants who have received autologous HSCT within 6 weeks before the first administration or have received allogeneic HSCT within 3 months before the first administration;\n13. Any active acute graft-versus-host disease (GvHD) grade 2-4 (according to the Glucksberg standard), or active chronic GvHD requiring systemic treatment;\n14. Any systemic treatment for GVHD within 2 weeks before the first administration;\n15. Participants with positive HIV antibody; participants with active HBV infection: positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood HBV DNA above the upper limit of normal; positive for HCV antibody and positive for HCV RNA in peripheral blood;\n16. Participants have active infections (including bacterial, viral, and fungal infections) that require systemic intravenous antibiotics treatment as judged by the investigator to have clinical significance;\n17. Participants with significant active cardiovascular disease within the past 6 months, including but not limited to the following conditions: ≥ III grade heart failure according to the New York Heart Association (NYHA) definition; angina pectoris, unstable angina pectoris, myocardial infarction requiring surgical treatment; uncontrolled hypertension (i.e., systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 90 mmHg) after treatment; arrhythmia not controlled; echocardiography-measured resting left ventricular function ejection fraction less than 50%; QT interval: male \\> 450 msec, female \\> 470 msec (according to the QTcF formula), or receiving known drugs that prolong QT\u002FQTc interval, or having other factors that may prolong QTc interval; or for those whose QT interval remains \\> 450 msec after treatment for QT interval prolongation;\n18. Participants with a history of other malignancies within the past 5 years, but excluding cured cutaneous basal cell carcinoma, localized skin squamous cell carcinoma, cervical carcinoma in situ, or breast carcinoma in situ;\n19. Participants with uncontrolled third space effusion (such as pleural effusion, ascites, pericardial effusion), requiring repeated drainage;\n20. Participants who have had interstitial lung disease (ILD)\u002Finterstitial pneumonia in the past or currently, and deemed by the investigator not suitable for inclusion in this study;\n21. Have a clear allergy to immunoglobulin or injectable belinotuzumab monoclonal antibody and its other components;\n22. Within the 4 weeks prior to the administration of this study, the participant has participated in other clinical trials of intervention drugs or medical devices, or is currently receiving treatment in other clinical trials (excluding non-interventional studies);\n23. Circumstances deemed unsuitable for participation in the trial by the investigator (such as, the investigator believes it may pose risks to the participant's safety or interfere with the evaluation, procedures, or completion of any other clinically significant medical history or having any other clinically significant disease at present (excluding those listed above).",{"count":356,"type":22},212,[250],"A Randomized, Double-Blind, Positive-Controlled, Multicenter Clinical Study to Compare the Similarities in Pharmacokinetics, Efficacy, Safety and Immunogenicity Between Injectable BLB101 and Blincyto® in Adult Participants with R\u002FR CD19+ B-ALL. Provide evidence for the approval and marketing of the drug for its targeted indication.\n\nPrimary Objectives：\n\n1. To compare the pharmacokinetic similarity between Injectable BLB101 and Blincyto® in participants with R\u002FR B-ALL.\n2. To compare the efficacy similarity between Injectable BLB101 and Blincyto® in participants with R\u002FR B-ALL.\n\nPrimary Endpoints:\n\n1. Css and area AUC0-24,d1 of Injectable BLB101 versus Blincyto® in participants with R\u002FR B-ALL.\n2. CR\u002FCRh within the first two induction cycles of treatment with Injectable BLB101 and Blincyto® in participants with R\u002FR B-ALL, as assessed by the IRC per the response criteria for ALL.\n\nThis study plans to enroll approximately 212 participants, who will be randomized at a 1:1 ratio into the following two groups:\n\nTest group: BLB101 for injection Control group: Blinatumomab for injection (Blincyto®) A stratified block randomization method will be adopted. The randomization stratification factors are as follows:a) Creatinine clearance (≤90 mL\u002Fmin vs \\>90 mL\u002Fmin);b) Baseline leukemic cell proportion (≤50% vs \\>50%);c) Relapsed\u002Frefractory status (first relapse vs ≥2 relapses or refractory disease).\n\nFor each participant, the overall study procedure is outlined as follows: Participants will receive treatment with either BLB101 for injection or Blincyto®. Each treatment cycle consists of 6 weeks, including 4 weeks of dosing followed by a 2-week treatment-free interval. Each participant is required to complete the first 2 induction treatment cycles (i.e., an induction treatment period of up to 12 weeks), after which the participant will be considered to have fulfilled the primary study objectives.",[360],"Precursor B-cell Acute Lymphoblastic Leukemia",{"date":362,"type":33},"2026-07-23",{"date":364,"type":22},"2026-08-09",{"date":366,"type":22},"2028-10-10",{"name":39,"class":40},{"id":369,"slug":370,"hasResults":12,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":12,"sex":17,"minAge":71,"maxAge":4,"enrollmentInfo":375,"targetDuration":4,"studyType":23,"phases":377,"briefSummary":378,"conditions":379,"keywords":4,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":381,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":106},"100630860","chemotherapy-with-targeted-immunotherapy-for-newly-diagnosed-ph-all-100630860","NCT07493161","Chemotherapy With Targeted-Immunotherapy for Newly Diagnosed Ph+ ALL","Low-intensity Chemotherapy Combined With Targeted-Immunotherapy for Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Prospective Clinical Cohort Study","Inclusion Criteria:\n\n* Newly diagnosed ALL with t(9;22)(q34;q11) or BCR::ABL1 positivity (by PCR or FISH).\n* Age ≥ 14 years.\n* ECOG performance status ≤ 2.\n* Adequate organ function: Total bilirubin \\\u003C1.5x ULN; AST\u002FALT ≤2.5x ULN; Serum creatinine \\\u003C2x ULN; Cardiac enzymes \\\u003C2x ULN; Serum amylase ≤1.5x ULN; Left ventricular ejection fraction (LVEF) \\>45%.\n* Male and female patients of childbearing potential must agree to use effective contraception.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Diagnosis of chronic myeloid leukemia in chronic, accelerated, or blast phase.\n* Prior systemic anti-leukemic therapy for ALL (except corticosteroids or hydroxyurea for cytoreduction prior to enrollment).\n* Myocardial infarction within 12 months prior to enrollment; uncontrolled\u002Funstable angina, congestive heart failure, uncontrolled hypertension or arrhythmia.\n* Uncontrolled active severe infection.\n* Active psychiatric illness that may hinder treatment completion or informed consent.\n* Any other condition deemed unsuitable for the study by the investigator.",{"count":376,"type":22},110,[25],"This is an open-label, prospective clinical cohort study evaluating the efficacy and safety of reduced-intensity chemotherapy combined with targeted therapy and immunotherapy in adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The study consists of two integrated parts. The first part is a randomized controlled comparison to investigate the role of venetoclax, a BCL2 inhibitor, when added to a backbone of olverembatinib (a third-generation TKI) and reduced-intensity chemotherapy (VPVO regimen) during the first three cycles of induction\u002Fconsolidation therapy. The second part is a single-arm exploration of inotuzumab ozogamicin (InO) combined with TKI and chemotherapy as a consolidation strategy for patients who complete the 90-day primary endpoint assessment but do not receive blinatumomab, offering an alternative to blinatumomab-based regimens. The primary endpoint for the venetoclax part is the rate of BCR-ABL \\\u003C 0.01% at day 90. The primary endpoint for the InO consolidation part is modified event-free survival (EFS) from the start of InO treatment. Key secondary endpoints include overall survival (OS), relapse-free survival (RFS), cumulative incidence of molecular and hematologic relapse, NGS MRD negativity rates, and safety profiles including cardiovascular events and SOS\u002FVOD. The study aims to enroll 110 patients in the initial phase and an additional 78 patients for the InO consolidation phase.",[380],"Ph+ ALL",{"date":362,"type":33},{"date":383,"type":33},"2026-04-10",{"date":385,"type":22},"2030-03-30",{"name":39,"class":40},{"id":388,"slug":389,"hasResults":12,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":393,"eligibilityCriteria":394,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":395,"targetDuration":4,"studyType":23,"phases":397,"briefSummary":398,"conditions":399,"keywords":400,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":401,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":106},"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 (AL-003)","AL-003","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":396,"type":22},21,[53],"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.",[123],[123,187,189],{"date":362,"type":33},{"date":403,"type":33},"2025-09-04",{"date":405,"type":22},"2027-12-01",{"name":39,"class":40},{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":413,"eligibilityCriteria":414,"healthyVolunteers":12,"sex":17,"minAge":415,"maxAge":18,"enrollmentInfo":416,"targetDuration":4,"studyType":23,"phases":418,"briefSummary":419,"conditions":420,"keywords":424,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":427,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":162},"100574819","phase-2-newly-diagnosed-intermediatehigh-risk-pediatric-b-cell-all-protocol-100574819","NCT06764238","Newly-diagnosed Intermediate\u002FHigh Risk Pediatric B-cell ALL Protocol","Chinese Children's Cancer Group-2025 Protocol for Newly Diagnosed for Intermediate\u002FHigh Risk Childhood B-cell ALL","CCCG-I\u002FHR-ALL","Inclusion Criteria:\n\n1. Age older than 1 month to younger than 18 years.\n2. Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.\n3. Diagnosis of B-ALL by immunophenotyping.\n\nExclusion Criteria:\n\n1. Low-risk ALL\n2. sIgM+\n3. Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria.\n4. ALL evolved from chronic myeloid leukemia (CML).\n5. Down's syndrome, or major congenital or hereditary disease with organ dysfunction\n6. Secondary leukemia\n7. Known underlying congenital immunodeficiency or metabolic disease\n8. Congenital heart disease with cardiac insufficiency.\n9. Treated with glucocorticoids for ≥14 days, or ABL kinase inhibitors for \\> 7 days within one month before enrollment, or any chemotherapy or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression)","1 Month",{"count":417,"type":22},1800,[53,250],"Building upon the results from the CCCG-ALL-2015, CCCG-ALL-2020 multicenter study cohort, concurrent research findings, and the latest clinical trials, the CCCG-ALL-2025 I\u002FHR-B-ALL is thus developed to further improve the event-free survival (EFS), and overall survival (OS), and quality of life (QoL) of children with intermediate- and high- risk B-cell childhood acute lymphoblastic leukaemia (I\u002FHR-B-ALL), while decreasing adverse reactions and transplantation rates. This trial primarily aims to explore:\n\n1. The efficacy of two randomized Blinatumomab application scheme on I\u002FHR-ALL as determined by MRD negatvitiy rate.\n2. The efficacy of modified mini-hyperCVD + Venetoclax in I\u002FHR-ALL cannot afford blinatumomab, in contrast to historical control as determined by MRD negatvitiy rate.",[421,422,423],"Acute Lymphoblastic Leukemia ALL","Childhood Leukemia, Acute Lymphoblastic","B Cell Acute Lymphoblastic Leukemia (B-ALL)",[425,426],"blinatimomab","venetoclax",{"date":362,"type":33},{"date":429,"type":33},"2025-01-03",{"date":431,"type":22},"2031-06",{"name":39,"class":40},{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":4,"eligibilityCriteria":439,"healthyVolunteers":440,"sex":17,"minAge":18,"maxAge":441,"enrollmentInfo":442,"targetDuration":4,"studyType":23,"phases":443,"briefSummary":444,"conditions":445,"keywords":447,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":451,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":106},"100573392","bcmacd3-bsab-in-the-treatment-of-high-risk-smoldering-multiple-myeloma-100573392","NCT06745687","BCMA\u002FCD3 BsAb in the Treatment of High-risk Smoldering Multiple Myeloma","A Prospective, Multi-center, Single-arm Clinical Trial of BCMA\u002FCD3 BsAb in the Treatment of High-risk Smoldering Multiple Myeloma","Inclusion Criteria:\n\n1. Know and voluntarily sign an informed consent form (ICF).\n2. Age ≥18 years.\n3. Definite diagnosis of SMM: According to IMWG Criteria 10, the patient must have histologically or cytologically confirmed smoldering multiple myeloma (SMM), including:\n\n   1. Serum M protein ≥3 g \u002FdL and\u002For BMPCs≥10%(but not more than 60%)\n   2. No anemia: hemoglobin ≥10 g \u002FdL\n   3. No renal failure: serum creatinine ≥2.0 mg\u002FdL\n   4. No hypercalcemia: calcium ≥10.5 mg\u002FdL\n   5. dissolving bone lesions without radiographic indications: X-ray, CT, or positron emission tomography (PET)\u002FCT without dissolving bone lesions, with no more than 1 lesion on whole-body MRI (Note: In the investigator's judgment, whole-body CT or PET\u002FCT may replace MRI for patients with contraindications or for whom MRI is not available).\n   6. FLC ratio \\\u003C100 (unless light chain ≤10 mg \u002FdL is involved) Note: Anemia, renal failure and hypercalcemia are allowed if there is evidence that anemia, renal failure, hypercalcemia or bone lesions are not associated with multiple myeloma (MM).\n4. High-risk SMM are defined as meeting one or more of the three criteria in the following part: (i) Mayo 2018, (ii) IMWG 2020 and (iii) evolving pattern.\n\n   (i)Mayo 2018\n   * M protein \\> 2 g\u002FdL ② The ratio of affected to unaffected FLC was \\> 20 ③BMPC \\> 20% of the 3 items meet any 2 or more\n\n   (ii) IMWG 2020\n   * FLC ratio 0-10: 0 points 10-25: 2 points 25-40: 3 points \\>40: 5 points\n\n     ②M protein (g\u002FdL) 0-1.5: indicates 0 points 1.5-3: 3 points \\>3: 4 points\n\n     ③BMPC (%) 0-15: 0 points 15-20: 2 points 20-30: 3 points 30-40: 5 points \\>40: 6 points\n\n     ④FISH \\* : Yes: 2 points None: 0 points The sum of the four points is greater than or equal to 9 （iii）Progression model\n   * Necessary condition: BMPC\\>10% ② Sufficient conditions: a. Serum M protein \\>3 g\u002FdL b. IgA type SMM c. Immune paralysis (reduction of two uninvolved homologous immunoglobulins) d. The proportion of free light chain (FLC) in serum that is affected\u002Fnot affected \\> 8 (but \\\u003C100) e.M protein level increased (SMM type increased; Serum M protein level was increased by ≥25% twice in 6 months.\n\n   F.BMPC: 50%-59% g. Abnormal plasma cell immunophenotype (95% + of cloned BMPC) and reduction of one or more uninvolved immunoglobulin types.\n\n   h.≥5% of cells had chromosomal abnormalities (t (4,14) or del 17 p or 1 q acquisition i. Increased circulating plasma cells (PCs\\>5×106\u002FL or 5%) j. Merri indicates diffuse abnormalities or 1 focal lesion, and\u002For increased uptake of focal lesion in PET-CT class without underlying osteolytic osteopathy. Meet the necessary conditions, 1 or more sufficient conditions.\n\n   \\*FISH exceptions are defined as the presence of any of the following: t (4,14), t (14,16), 1 q amplification, del 13 qt, t (4,20)\n5. ECOG physical status score ≤2 points.\n6. Meeting the following laboratory indicators within 28 days prior to study participation:\n\n   a. neutrophils absolute value (ANC) \\>1000\u002Fml b. Platelet count (PLC)\\> 75,000 \u002Fml c. Total bilirubin ≤2 mg\u002FdL d. Glutamic oxalic aminotransferase (AST) \\\u003C2.5 times the conventional upper limit (ULN) e. Alanine aminotransferase (ALT) \\\u003C2.5 times the upper limit of normal (ULN) f. Estimated creatinine clearance (CLcr)≥60 mL\u002Fmin.\n7. Non-childbearing women meet the entry requirements; Female patients of childbearing age must have a negative serum (beta-human chorionic gonadotropin) or urine pregnancy test at the time of screening.\n8. Men, women of childbearing age, and their partners voluntarily use contraception deemed effective by investigators during treatment and for at least three months after CAR T cell transfusion.\n9. Male patients must agree not to donate sperm from the initial screening period until 90 days after the last medication.\n10. Patients must be willing and able to complete study procedures and follow-up examinations.\n\nNote: Fertile women are all women who have begun menstruating and are not in late menopause and who have not undergone surgical sterilization (e.g., hysterectomy, bilateral tubal ligation, bilateral oophorectomy). Postmenopause is defined as more than 12 consecutive months of amenorrhea for an unspecified reason. Women who are using mechanical birth control methods such as oral contraceptives or intrauterine devices should be considered fertile. Male subjects (including those who have undergone vasectomy) must consent to the use of condoms during sex with women of childbearing age and must not plan to impregnate the woman during the study drug use period from the date of signing the informed consent form and within 3 months after the last study drug receipt.\n\nExclusion Criteria:\n\n1. Diagnosis of symptomatic multiple myeloma: refer to the Chinese Guidelines for Diagnosis and Treatment of multiple myeloma (revised in 2022);\n2. Along with other tumors that must be treated.\n3. Previously received immunotherapy against BCMA targets.\n4. The researchers judged that BCMA\u002FCD 3 dual antibody therapy is not suitable, such as severe cardiopulmonary disease and other conditions that are not suitable for BCMA\u002FCD 3 dual antibody therapy.\n5. Received SMM treatment within six months.\n6. Known intolerance, allergy or contraindications to BCMA\u002FCD 3 dual anti-active ingredients.\n7. Patients with unstable or active cardiovascular and cerebrovascular diseases meet any of the following criteria:\n\n   1. Unstable angina pectoris, symptomatic myocardial ischemia, myocardial infarction, or coronary artery reconstruction had occurred within 180 days prior to initial administration.\n   2. Uncontrolled hypertension (\\>140\u002F90 MMHG, with a blood pressure fluctuation of more than 180\u002F100 MMHG over 6 months);\n   3. Uncontrolled and clinically significant conduction abnormalities (e.g., patients with ventricular arrhythmias controlled by antiarrhythmic drug therapy), not excluding patients with first-degree AV block or asymptomatic left anterior bundle branch block\u002Fright bundle branch block (LAFB\u002FRBBB);\n   4. Echocardiographic left ventricular ejection fraction (LVEF) \\\u003C 40%;\n   5. History of stroke or intracranial hemorrhage within 12 months prior to screening;\n   6. Severe thrombotic events before treatment.\n\n9\\) Known active human immunodeficiency virus (HIV) infection or HIV seropositivity.\n\n10\\) Active hepatitis B or C infection. Screening requires hepatitis serological testing. If hepatitis B surface antigen is positive, a negative DNA polymerase chain reaction (PCR) result is required to be confirmed before enrollment (after anti-HBV treatment, a negative DNA polymerase PCR result is required before enrollment). If the hepatitis C antibody is positive, an RNA PCR test is performed and the result before enrollment is confirmed to be negative.\n\n11\\) Pregnant or lactating women. 12) Any active gastrointestinal dysfunction that affects the patient's ability to swallow pills, or any active gastrointestinal dysfunction that may affect the absorption of investigational therapeutic drugs.\n\n13\\) Patients had major surgery (for example, requiring general anesthesia) within 2 weeks before enrollment began, or will not fully recover from surgery, or have surgery scheduled during the time they plan to participate in the study. Kyphoplasty or spondyloplasty is not considered major surgery. Note: Patients who plan to perform surgery under local anesthesia may participate in the study.\n\n14\\) Received live attenuated vaccine within 4 weeks prior to administration of the first investigational drug.",true,"78 Years",{"count":116,"type":22},[25],"The purpose of this study is to evaluate the safety and efficacy of CM-336, which is a BCMA\u002FCD3 BiTE, in the treatment of high risk smoldering multiple myeloma.",[446],"High Risk Smoldering Multiple Myeloma",[448,449,450],"high risk smoldering multiple myeloma","BCMA\u002FCD3 BiTE","CM-336",{"date":362,"type":33},{"date":453,"type":33},"2024-12-30",{"date":455,"type":22},"2029-08-01",{"name":39,"class":40},{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":463,"eligibilityCriteria":464,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":310,"enrollmentInfo":465,"targetDuration":4,"studyType":23,"phases":467,"briefSummary":468,"conditions":469,"keywords":471,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":473,"startDateStruct":474,"completionDateStruct":475,"leadSponsor":477,"locationsCount":106},"100648752","phase-1-a-study-of-kiv-318-injection-in-patients-with-bcma-positive-relapsedrefractory-multiple-myeloma-100648752","NCT07726160","A Study of KIV-318 Injection in Patients With BCMA-Positive Relapsed\u002FRefractory Multiple Myeloma","A Single-arm, Open-label, Multicenter, Dose-escalation Clinical Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of KIV-318 Injection in Patients With Relapsed\u002FRefractory Multiple Myeloma.","KIV-318","Inclusion Criteria:\n\n* Subjects are eligible for inclusion only if they meet all of the following criteria:\n\n  1. Age between 18 and 70 years (inclusive), regardless of gender;\n  2. Diagnosis of multiple myeloma (MM) confirmed per the IMWG diagnostic criteria. and presenting with relapsed\u002Frefractory (r\u002Fr) MM following at least ≥3 prior lines of therapy. Prior therapies must have included proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), and\u002For CD38 monoclonal antibodies. While prior exposure to all three therapeutic classes is preferred, subjects must have received at least two of these treatment categories (PIs, IMiDs, and\u002For anti-CD38) during their prior therapy;\n  3. Subjects with r\u002Fr MM at screening, with documented disease progression, or who are considered refractory, either during or within 12 months after the most recent anti-myeloma treatment.\n  4. The following cohort-specific criteria must be satisfied:\n\n     For Cohort A: No previous exposure to T-cell engager (TCE) agents and\u002For CAR-T cell therapy; For Cohort B: Prior treatment with TCEs and\u002For CAR-T therapy, and positive for BCMA target expression. Prior TCE therapy is defined as completion of at least the full initial step-dose regimen, or cumulative administration of at least 2 therapeutic doses. Prior CAR-T therapy is defined as having received at least one infusion of CAR-T cells targeting any antigen; For Cohort B (additional): In patients whose most recent anti-tumor therapy was a TCE, enrollment will be considered only if the TCE was discontinued due to intolerance or for reasons other than disease progression, with a disease status of stable disease (SD) or better at the time of discontinuation, and with no evidence of rapid disease progression prior to screening.\n  5. Measurable disease at screening, meeting at least one of the following criteria:\n\n     Serum M-protein level ≥0.5 g\u002FdL; or urine M-protein level ≥200 mg\u002F24h; or for light-chain multiple myeloma in which disease is not measurable in serum or urine: involved serum immunoglobulin free light chain (sFLC) ≥10 mg\u002FdL with an abnormal serum immunoglobulin κ\u002Fλ free light chain ratio.\n  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 , and an estimated life expectancy of ≥3 months.\n  7. Bone marrow function test results meeting the following requirements:\n\n     Hemoglobin ≥60 g\u002FL (with no red blood cell transfusion within 1 week prior to screening), and the use of recombinant human erythropoietin is permitted; Absolute neutrophil count (ANC) ≥0.75×10⁹\u002FL (with no granulocyte colony-stimulating factor \\[G-CSF\\] use within 1 week prior to screening, or no pegylated G-CSF use within 2 weeks prior to screening); Platelet count (PLT) ≥50×10⁹\u002FL; Absolute lymphocyte count (ALC) ≥0.5×10⁹\u002FL; CD3-positive T-cell absolute count ≥0.15×10⁹\u002FL.\n  8. Adequate organ function, defined as:\n\n     Left ventricular ejection fraction (LVEF) ≥45% assessed by echocardiography, with no clinically significant abnormalities on electrocardiogram (ECG); Creatinine clearance (CrCl) ≥30 mL\u002Fmin, calculated using the Cockcroft-Gault formula ; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × upper limit of normal (ULN); Total bilirubin (TBIL) and alkaline phosphatase (AKP\u002FALP) ≤2.0 × ULN (≤3.0 × ULN for patients with Gilbert's syndrome); Prothrombin time (PT) ≤1.5 × ULN, activated partial thromboplastin time (APTT) \\\u003C1.5 × ULN, and international normalized ratio (INR) \\\u003C1.5 × ULN.\n  9. Male subjects with reproductive potential and female subjects of childbearing potential must agree to use effective contraceptive measures from the time of signing the informed consent form (ICF) through 1 year after administration of the study drug. Female subjects of childbearing potential must have a negative serum pregnancy test at screening and prior to drug infusion, and must not be lactating.\n  10. Subjects or their legally authorized representatives must agree to participate in this clinical trial and sign the informed consent form (ICF), indicating their understanding of the purpose and procedures of the trial and their willingness to participate in the study.\n\nExclusion Criteria:\n\n* Subjects meeting any of the following criteria will be excluded from enrollment in this study:\n\n  1. Receipt of any type of T-cell engager (TCE) therapy within 8 weeks or 5 half-lives (whichever is shorter) prior to the first dose of the investigational drug.\n  2. Receipt of any of the following within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose of the investigational drug:\n\n     Participation in other interventional clinical trials; Receipt of any anti-tumor chemotherapy, hormonal therapy, targeted therapy, epigenetic therapy, or treatment using invasive investigational medical devices.\n  3. Receipt of proteasome inhibitors, immunomodulatory agents, radiotherapy, or traditional Chinese medicine preparations approved for anti-tumor indications within 2 weeks or 5 half-lives (whichever is shorter) prior to the first dose of the investigational drug.\n  4. Presence of meningeal, brainstem, or spinal cord metastasis and\u002For compression, or active central nervous system (CNS) metastasis.\n  5. Receipt of allogeneic hematopoietic stem cell transplantation (allo-HSCT) within 6 months prior to infusion, or autologous hematopoietic stem cell transplantation (auto-HSCT) within 3 months prior to infusion.\n  6. Presence of active second primary malignancies, with the following exceptions: malignancies that have received curative treatment with no known active disease for ≥2 years prior to enrollment; or adequately treated non-melanoma skin cancer with no current evidence of disease.\n  7. Prior treatment with any agent pseudotyped with vesicular stomatitis virus G (VSVG).\n  8. Presence of severe, uncontrolled active infection (bacterial, viral, fungal, etc.) at screening.\n  9. Within 6 months prior to infusion:\n\n     Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with a detectable peripheral blood HBV DNA titer above the normal range; Positive for hepatitis C virus (HCV) antibody with a detectable peripheral blood HCV RNA titer above the normal range; Positive for human immunodeficiency virus (HIV) antibody; Positive for syphilis screening test.\n  10. Presence of symptomatic heart failure or severe cardiac arrhythmias, including:\n\n      New York Heart Association (NYHA) Class III or IV congestive heart failure; Myocardial infarction or coronary artery bypass grafting (CABG) or coronary stent implantation within ≤6 months prior to signing the ICF; Clinically significant ventricular arrhythmias, or history of syncope of unknown cause (except for cases due to vasovagal or dehydration); History of severe non-ischemic cardiomyopathy.\n  11. Clinically significant comorbidities, including:\n\n      Primary immunodeficiency; Stroke or seizure within 6 months prior to screening; Significant clinical evidence of dementia or altered mental status; Parkinson's disease or parkinsonian movement disorder or history thereof.\n  12. Major surgery within 2 weeks prior to study drug administration, or planned major surgery within 2 weeks after study drug administration, excluding surgeries performed under local anesthesia.\n  13. Uncontrolled hypertension, hypercalcemia, or diabetes mellitus.\n  14. Administration of live attenuated vaccines within 1 month prior to study drug administration.\n  15. Known severe hypersensitivity reaction to KIV-318 or its formulation components (e.g., protein components).\n  16. Known severe hypersensitivity reaction to tocilizumab.\n  17. Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this study.",{"count":466,"type":22},30,[52],"A single-arm, open-label, multicenter, dose-escalation clinical trial to evaluate the safety, tolerability, and preliminary efficacy of KIV-318 Injection in patients with relapsed\u002Frefractory multiple myeloma.",[470],"Relapse and\u002For Refractory Multiple Myeloma",[472],"BCMA-positive relapsed\u002Frefractory multiple myeloma",{"date":344,"type":33},{"date":128,"type":22},{"date":476,"type":22},"2029-07-01",{"name":39,"class":40},{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":23,"phases":486,"briefSummary":487,"conditions":488,"keywords":490,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":498,"locationsCount":106},"100647957","phase-1-phase-iii-study-of-anti-cd38-monoclonal-antibody-in-refractory-severe-aplastic-anemia-100647957","NCT07714512","Phase I\u002FII Study of Anti-CD38 Monoclonal Antibody in Refractory Severe Aplastic Anemia","A Phase I\u002FII Study on the Safety and Efficacy of CD38 Monoclonal Antibody in the Treatment of Refractory Severe Aplastic Anemia","Inclusion Criteria:\n\n* Diagnosed with primary acquired aplastic anemia according to the 2024 British Society for Haematology guideline, Guidelines for the Diagnosis and Management of Adult Aplastic Anaemia, and the Chinese Guideline for the Diagnosis and Treatment of Aplastic Anemia (2022 edition) issued by the Hematology Branch of the Chinese Medical Association.\n* Previously diagnosed with severe aplastic anemia (SAA) or very severe aplastic anemia (VSAA), with no response or relapse after receiving anti-thymocyte\u002Fanti-lymphocyte globulin (ATG\u002FALG) in combination with standard-dose cyclosporine for at least 6 months, and standard-dose thrombopoietin receptor agonist (TPO-RA) therapy for at least 4 months.\n* Hemoglobin \\\u003C90 g\u002FL or platelet count \\\u003C30×10\\^9\u002FL\n* Unsuitable for or unwilling to undergo hematopoietic stem cell transplantation, with no better available treatment options.\n* Age ≥18 years, regardless of gender.\n* Eastern Cooperative Oncology Group (ECOG) performance status score ≤2\n* Willing and able to comply with the requirements for this study and written informed consent.\n\nExclusion Criteria:\n\n* Diagnosed with congenital bone marrow failure syndromes\n* Bone marrow reticulin fibrosis grade ≥2\n* Subjects with a paroxysmal nocturnal hemoglobinuria (PNH) clone ≥50% or active hemolysis\n* Subjects with clonal cytogenetic abnormalities characteristic of myelodysplastic syndromes, except +8, del(20q), and -Y\n* Active bacterial, viral, or fungal infection within 2 weeks before the first dose of the investigational drug, excluding common cold and onychomycosis, or any other serious infection. Any anti-infective treatment course for infection must have been completed at least 2 weeks before the first dose. Subjects with a history of HIV infection or positive HIV antibody during screening; positive Treponema pallidum antibody during screening; active tuberculosis, defined as chest imaging or other relevant examinations within 3 months before the first dose of the investigational drug or during screening suggesting active tuberculosis infection; or active hepatitis during screening, defined as hepatitis B surface antigen (HBsAg) positivity, or hepatitis B core antibody (HBcAb) positivity with hepatitis B virus (HBV) DNA ≥30 IU\u002FmL, or hepatitis C virus (HCV) antibody positivity with HCV RNA positivity\n* Active bleeding in the gastrointestinal tract, respiratory tract, central nervous system, or other sites\n* A history of any clinically significant disease that, in the investigator's opinion, would pose a safety risk to the subject if participating in the study, or would affect the evaluation of efficacy or safety if the disease\u002Fcondition worsens during the study, including but not limited to: a. cardiovascular diseases, such as a history of acute myocardial infarction or unstable angina within the past year, severe arrhythmia such as frequent multifocal premature ventricular contractions, ventricular tachycardia, or ventricular fibrillation, congestive heart failure, arterial or venous thrombosis, or New York Heart Association (NYHA) class III-IV cardiac function; b. a history of psychiatric disorders, severe cerebrovascular disease, or cognitive sequelae\n* Use of agents targeting B cells or plasma cells within 3 months before the first dose of the investigational drug or anticipated use during the clinical trial\n* Treatment with anti-lymphocyte globulin or anti-thymocyte globulin within 6 months before the first dose of the investigational drug\n* Treatment with tacrolimus, sirolimus, cyclophosphamide, anti-CD52 monoclonal antibody, or similar therapies within 4 weeks or 5 half-lives, whichever is shorter, before the first dose of the investigational drug\n* Planned participation in another clinical trial, or prior exposure to another investigational product before the first dose, with an interval of less than 4 weeks or 5 half-lives of the drug, whichever is shorter\n* Receipt of a live attenuated vaccine within 4 weeks before the first dose of the investigational drug or planned receipt during the study, or receipt of a COVID-19 vaccine within 7 days before dosing\n* Prior treatment targeting CD38\n* Women who are pregnant or breastfeeding, or who plan to become pregnant or breastfeed during the study\n* Patients considered to be ineligible for the study by the investigator for reasons other than the above",{"count":203,"type":22},[52,53],"This is a phase I\u002FII clinical study in adult patients with refractory severe aplastic anemia (SAA). Eligible patients must meet the criteria for refractory SAA and have a platelet count (PLT) \\\u003C30 × 10\\^9\u002FL and\u002For hemoglobin (HGB) \\\u003C90 g\u002FL at enrollment. If the phase I results demonstrate an acceptable safety profile and allow determination of the maximum tolerated dose (MTD), the phase II part will be initiated directly to evaluate the efficacy of isatuximab.",[489],"Aplastic Anemia",[491,492],"Isatuximab","Severe aplastic anemia","2026-07-15",{"date":128,"type":33},{"date":496,"type":33},"2026-06-30",{"date":130,"type":22},{"name":39,"class":40},{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":4,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":23,"phases":508,"briefSummary":509,"conditions":510,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":512,"startDateStruct":514,"completionDateStruct":515,"leadSponsor":517,"locationsCount":4},"100646278","phase-1-a-clinical-study-on-the-efficacy-and-safety-of-zeprumetostat-in-relapsedrefractory-large-granular-lymphocyte-leukemia-100646278","NCT07692529","A Clinical Study on the Efficacy and Safety of Zeprumetostat in Relapsed\u002FRefractory Large Granular Lymphocyte Leukemia","A Prospective and Exploratory Clinical Study on the Efficacy and Safety of Zeprumetostat in Relapsed\u002FRefractory Large Granular Lymphocyte Leukemia","Inclusion Criteria:Male or female age ≥ 18 years Diagnosis of T-cell large granular lymphocytic leukemia (T-LGLL) Meet any of the following indications for treatment：\n\n1. Hemoglobin \\\u003C 100g\u002FL or RBC transfusion dependence\n2. Neutrophil count \\\u003C0.5×10\\^9\u002FL or neutrophil count decreased with recurrent infection\n3. Progressive splenomegaly and\u002For Massive Splenomegaly\n4. Combined with autoimmune diseases requiring treatment, such as rheumatoid arthritis, autoimmune thyroiditis, etc.\n5. Severe B symptoms Failure or intolerance to a first-line therapy ECOG performance status ≤2 Expected survival ≥ 6 months Willing and able to comply with the requirements for this study and written informed consent.\n\n   \\-\n\n   Exclusion Criteria:History of other lymphoproliferative neoplasms Had malignant tumor within 5 years before enrollment, exclusive of cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial tumor, cervical carcinoma in situ or other indolent tumors Previously received organ or stem cell transplantation. Patients with active infection within 2 weeks before giving the first dose of medication Patients with HBV, HCV, HIV or other infections that require treatment History of immunodeficiency, or congenital immunodeficiency disorders Any severe and\u002For uncontrolled medical conditions or other conditions that could affect their participation in the study, including clinically significant cardiac diseases, refractory hypertension, metabolic disorders and other diseases that seriously affect the function of the gastrointestinal tract within the 6 months prior to enrollment.\n\n   Abnormal liver function: two consecutive examinations with an interval of ≥1 week suggest that ALT and AST are 2.5 times higher than the upper limit of normal values Renal impairment: creatinine clearance \\\u003C60ml\u002Fmin Having a history of mental illness or suffering from severe cerebrovascular diseases or cognitive sequelae History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe impairment of lung function, etc.\n\n   Difficulty in swallowing, chronic diarrhea and intestinal obstruction, there are multiple factors that affect the administration and absorption of medications.\n\n   Received attenuated vaccine 4 in weeks before enrollment Participation in another clinical trial within 4 weeks before the start of this trial Have an allergy to zeprumetostat or any other part of this medicine. Previously treated with other EZH2 inhibitor. Pregnant or breast-feeding patients Patients considered to be ineligible for the study by the investigator for reasons other than the above\n\n   \\-",{"count":507,"type":22},10,[52],"This study is a single-arm, prospective, exploratory clinical trial aimed at exploring the efficacy and safety of zeprumetostat in patients with relapsed\u002Frefractory large granular T-cell leukemia. The study is expected to enroll 10 patients with relapsed\u002Frefractory large granular T-cell leukemia for treatment with zeprumetostat .\n\nThe patients will undergo a maximum 4-week screening period and then enter the treatment phase, where they will receive zeprumetostat 350mg twice daily orally. The treatment lasts for 28 consecutive days as one cycle. If adverse events occur during the treatment, they will be handled according to the suspension and resumption standards.\n\nThe efficacy and safety will be evaluated after the patients complete two cycles of administration.",[511],"Evaluation of the Efficacy and Safety of Zeprumetostat in Relapsed\u002FRefractory Large Granular Lymphocyte Leukemia (T-LGLL)",{"date":513,"type":33},"2026-07-09",{"date":215,"type":22},{"date":516,"type":22},"2028-02-26",{"name":39,"class":40},{"id":519,"slug":520,"hasResults":12,"nctId":521,"briefTitle":522,"officialTitle":523,"acronym":4,"eligibilityCriteria":524,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":525,"enrollmentInfo":526,"targetDuration":4,"studyType":23,"phases":528,"briefSummary":530,"conditions":531,"keywords":533,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":538,"startDateStruct":540,"completionDateStruct":541,"leadSponsor":543,"locationsCount":106},"100646580","early-phase-1-meta-10-19-in-patients-with-relapsedrefractory-autoimmune-hemolytic-anemia-100646580","NCT07689604","META 10-19 in Patients With Relapsed\u002FRefractory Autoimmune Hemolytic Anemia","Phase I Clinical Study on the Safety and Tolerability of META 10-19 Infusion in Patients With Relapsed\u002FRefractory Autoimmune Hemolytic Anemia","Inclusion Criteria:\n\n* Aged 18 to 75 years, regardless of genders.\n* Diagnosis of AIHA (including warm antibody type, mixed warm and cold antibody type, cold agglutinin disease) or Evans syndrome, consistent with the Chinese Expert Consensus on the Diagnosis and Treatment of Autoimmune Hemolytic Anemia (2023), or the Diagnosis and Treatment of Autoimmune Hemolytic Anemia in Adults: Recommendations from the First International Consensus Meeting (Blood Rev, 2020), or the Chinese Expert Consensus on the Diagnosis and Treatment of Evans Syndrome (2024 Edition).\n* Definition of relapsed\u002Frefractory disease, meeting all of the following criteria:\n\n  1. Hemoglobin \\\u003C 10 g\u002FdL with clinical manifestations of hemolytic anemia;\n  2. After treatment with at least two immunosuppressive agents (which must include an anti-CD20 monoclonal antibody, with a cumulative dose of the anti-CD20 antibody reaching at least 375 mg\u002Fm² × 4, or a total dose of 2.0 g, or at least 6 cumulative administrations with an interval of ≥1 week between each);\n  3. Glucocorticoid therapy for no less than 3 months (except for those with comorbidities that contraindicate corticosteroid use, severe infection, severe osteoporosis, previous fractures, or intolerance to glucocorticoids).\n* Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2;\n* Estimated life expectancy ≥12 weeks;\n* Adequate organ function as assessed by laboratory tests: Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN); and minimal pulmonary reserve, defined as dyspnea ≤ grade 1 and oxygen saturation ≥ 93% while breathing room air; creatinine clearance (estimated by Cockcroft-Gault) ≥ 45 mL\u002Fmin; cardiac ejection fraction ≥ 50%, with no signs of pericardial effusion on echocardiography (ECHO) and no clinically significant electrocardiogram (ECG) abnormalities.\n* During the study period (from the signing of this informed consent form until at least 12 months after META 10-19 infusion, and until two consecutive PCR tests show no detectable CAR-T cells in the body), the study participant and their spouse\u002Fpartner must use appropriate and effective contraceptive measures (excluding rhythm method\u002Fcalendar-based contraception).\n* Study participants must sign a written informed consent form approved by the Ethics Committee prior to the initiation of any screening procedures.\n\nExclusion Criteria:\n\n* Previously diagnosed definite lymphoproliferative neoplasms; other malignant tumors within the past 5 years (excluding cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, breast carcinoma in situ, and cervical carcinoma in situ).\n* Secondary AIHA caused by drugs or infection.\n* Presence of active hepatitis or a history of severe liver disease or condition during the screening period:\n\n  1. Hepatitis B: HBsAg or HBeAg positive; or hepatitis B e antibody (HBe-Ab) and\u002For hepatitis B core antibody (HBc-Ab) positive with HBV-DNA copy number above the lower limit of detection.\n  2. Hepatitis C: Anti-HCV positive and HCV RNA ≥ lower limit of quantification (LLoQ).\n  3. Human immunodeficiency virus (HIV) antibody positive.\n  4. Active syphilis infection (excluding those with only positive syphilis-specific antibodies).\n* Previous history of organ transplantation or hematopoietic stem cell transplantation.\n* Severe cardiovascular diseases:\n\n  1. Cardiovascular disease with New York Heart Association (NYHA) class \\> 2 within 6 months prior to the first study drug administration.\n  2. Unstable angina or severe arrhythmia requiring medication, including QTcF \\> 480 ms (calculated by Fridericia's formula).\n  3. Other significant electrocardiogram (ECG) abnormalities, including second-degree type II atrioventricular block, third-degree atrioventricular block, bradycardia (ventricular rate \\\u003C 50 bpm with clinical symptoms), etc.\n  4. Myocardial infarction within the past 6 months.\n  5. Other cardiac diseases considered unsuitable for enrollment by the investigator.\n* Undergone major surgery within the past 4 weeks that is deemed by the investigator as unsuitable for enrollment.\n* Presence of active infection (e.g., sepsis, bacteremia, fungemia, uncontrolled pulmonary infection, active tuberculosis, etc.); active infection requiring intravenous anti-infective therapy within 7 days prior to screening.\n* Receipt of CAR T-cell therapy within 6 months prior to screening, or positivity for ADA, or positivity for HAMA, or receipt of in vivo CAR T-cell therapy within the previous 6 months; or a history of severe immediate hypersensitivity reaction to any cellular product, excipients, or related drugs used in this study.\n* Individuals with a history of epilepsy or other active central nervous system diseases (including but not limited to cerebrovascular accident, cerebral hemorrhage, cerebral infarction, severe traumatic brain injury, dementia, organic brain syndrome, etc.).\n* Women with a positive pregnancy test or who are breastfeeding; women of childbearing potential and all male study participants who are unwilling or unable to use effective contraceptive methods during the study period and for at least 12 months after study drug infusion.\n* Any other condition or circumstance that, in the investigator's opinion, would make the participant unsuitable for participation in this study.","75 Years",{"count":527,"type":22},18,[529],"EARLY_PHASE1","A Study of Metabolically Armed Autologous CD19 CAR T-Cell Therapy (META 10-19) in Patients with Relapsed\u002FRefractory Autoimmune Hemolytic Anemia",[532],"Autoimmune Hemolytic Anemia (AIHA)",[534,535,536],"META 10-19","Relapsed\u002FRefractory Autoimmune Hemolytic Anemia (AIHA)","IL-10","2026-07-06",{"date":539,"type":33},"2026-07-08",{"date":539,"type":22},{"date":542,"type":22},"2028-10-01",{"name":39,"class":40},{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":550,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":310,"enrollmentInfo":552,"targetDuration":4,"studyType":23,"phases":553,"briefSummary":554,"conditions":555,"keywords":557,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":560,"startDateStruct":561,"completionDateStruct":562,"leadSponsor":563,"locationsCount":106},"100646714","phase-1-sonrotoclax-and-bcma-bispecific-antibody-in-newly-diagnosed-systemic-al-amyloidosis-based-on-t1114-genetic-stratification-100646714","NCT07687004","Sonrotoclax and BCMA Bispecific Antibody in Newly Diagnosed Systemic AL Amyloidosis Based on t(11;14) Genetic Stratification","A Phase Ib\u002FII, Non-Randomized, Biomarker-Stratified Umbrella Study of Chemotherapy-Free Strategies in Newly Diagnosed Systemic AL Amyloidosis Based on t(11;14) Status: Sonrotoclax and a BCMA\u002FCD3 Bispecific Antibody (AL-005)","AL-005","Inclusion Criteria:\n\n* Able to understand and voluntarily sign the informed consent form (ICF).\n* Age ≥18 years and ≤70 years.\n* Confirmed diagnosis of primary light-chain amyloidosis, according to the diagnostic and treatment guidelines for primary light-chain amyloidosis, 2021 revised edition.\n\n  1. Subjects entering the phase Ib dose-escalation stage must also have confirmed t(11;14) translocation by FISH or other genetic testing.\n\nNewly diagnosed systemic AL amyloidosis, with no prior systemic anti-tumor therapy for AL amyloidosis.\n\n* Measurable disease at screening, defined as:\n\n  a) Difference between involved and uninvolved serum free light chains (dFLC) \\>20 mg\u002FL.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤3.\n* Adequate hepatic function, defined as total bilirubin \\\u003C1.5 × upper limit of normal (ULN) (total bilirubin \\\u003C3 × ULN for patients with Gilbert syndrome), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C3 × ULN.\n* Adequate renal function, defined as creatinine clearance ≥30 mL\u002Fmin, calculated using the Cockcroft-Gault formula.\n* Baseline oxygen saturation \\>92% on room air.\n* Hematologic parameters within 7 days before the start of screening meeting the following criteria: absolute neutrophil count ≥1.0 × 10⁹\u002FL, hemoglobin ≥70 g\u002FL without whole blood or red blood cell transfusion within 7 days, and platelet count ≥70 × 10⁹\u002FL without whole blood transfusion, platelet transfusion, or thrombopoietin receptor agonist treatment within 7 days; or deemed suitable for enrollment by the investigator based on clinical judgment.\n* Women of non-childbearing potential are eligible. Female patients of childbearing potential must have a negative serum β-human chorionic gonadotropin or urine pregnancy test at screening.\n* Male patients, women of childbearing potential, and their partners must voluntarily use effective contraceptive measures, as judged by the investigator, during the treatment period.\n* Male patients must agree not to donate sperm from the initial screening period until 90 days after the last dose of study treatment.\n* Patients must be willing and able to complete study procedures and follow-up assessments.\n\nNote: Women of childbearing potential are defined as all women who have experienced menarche and are not postmenopausal and have not undergone surgical sterilization, such as hysterectomy, bilateral tubal ligation, or bilateral oophorectomy. Postmenopausal status is defined as amenorrhea for more than 12 consecutive months without another specified cause. Women using oral contraceptives or mechanical contraceptive methods, such as intrauterine devices, should be considered to be of childbearing potential.\n\nMale subjects, including those who have undergone vasectomy, must agree to use condoms during sexual intercourse with women of childbearing potential and must have no plan to father a child from the date of signing the ICF, throughout the period of study drug administration, and for 3 months after the last dose of study treatment.\n\nExclusion Criteria:\n\n* Non-AL amyloidosis, including hereditary amyloidosis and other non-AL types of amyloidosis.\n* Diagnosis of symptomatic multiple myeloma, according to the Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma, 2022 revised edition. Patients whose diagnosis is based solely on a serum free light-chain ratio ≥100 are not excluded.\n* Peripheral neuropathy \\> grade 2 or painful neuropathy ≥ grade 2 at screening, regardless of whether the patient is currently receiving medication.\n* History of another malignancy, other than AL amyloidosis, within 5 years before randomization.\n* Known intolerance, allergy, or contraindication to the active ingredients of the BCMA\u002FCD3 bispecific antibody or sonrotoclax.\n* Unstable or active cardiovascular or cerebrovascular disease, meeting any of the following criteria:\n\n  1. Unstable angina, symptomatic myocardial ischemia, myocardial infarction, or coronary revascularization within 180 days before the first dose;\n  2. NT-proBNP \\>8500 ng\u002FL;\n  3. Congestive heart failure with hospitalization for cardiovascular disease within 4 weeks before randomization;\n  4. Heart failure judged by the investigator to be caused by ischemic heart disease, such as prior myocardial infarction with elevated cardiac enzymes and electrocardiographic changes, or uncorrected valvular disease, rather than AL amyloid cardiomyopathy;\n  5. History of sustained ventricular tachycardia or ventricular fibrillation, or history of atrioventricular (AV) node or sinoatrial (SA) node dysfunction requiring a pacemaker or implantable cardioverter-defibrillator (ICD) but without implantation. Patients with an implanted pacemaker or ICD may be enrolled;\n  6. Corrected QT interval using Fridericia's formula (QTcF) \\>500 msec. Patients with an implanted pacemaker may be enrolled regardless of the corrected QT interval result;\n  7. Supine systolic blood pressure \\\u003C90 mmHg;\n  8. Any other cardiovascular or cerebrovascular disease that, in the investigator's judgment, makes the subject unsuitable for participation in this study.\n\nKnown active human immunodeficiency virus (HIV) infection or HIV seropositivity.\n\n* Active hepatitis B or hepatitis C infection. Hepatitis serology testing is required at screening. If hepatitis B surface antigen is positive, a negative DNA polymerase chain reaction (PCR) result must be confirmed before enrollment. -For patients receiving anti-HBV therapy, a negative HBV DNA PCR result must be confirmed before enrollment. If hepatitis C antibody is positive, RNA PCR testing must be performed, and a negative result must be confirmed before enrollment.\n* Pregnant or breastfeeding women.\n* Any active gastrointestinal dysfunction that affects the patient's ability to swallow tablets, or any active gastrointestinal dysfunction that may affect the absorption of study treatment.\n* Major surgery, such as surgery requiring general anesthesia, within 2 weeks before enrollment, incomplete recovery from prior surgery, or planned surgery during the study period. Kyphoplasty or vertebroplasty is not considered major surgery. Patients scheduled to undergo procedures under local anesthesia may participate in the study.\n* Receipt of a live attenuated vaccine within 4 weeks before the first dose of study treatment.\n* Any active severe psychiatric or psychological disorder, medical disease, or other symptom or condition that, in the investigator's judgment, may affect treatment, compliance, or the ability to provide informed consent.\n\nContraindication to any required concomitant medication or supportive care.\n\n* Any disease or complication that may interfere with study procedures.\n* Unwillingness or inability to comply with the protocol.",{"count":21,"type":22},[52,53],"This study is a prospective, single-center, phase Ib\u002FII clinical trial designed to evaluate the tolerability of sonrotoclax plus dexamethasone in this phase Ib\u002FII umbrella study and to determine the recommended phase II dose (RP2D). It also aims to assess the safety and hematologic response rate of sonrotoclax plus dexamethasone in patients with newly diagnosed systemic light-chain amyloidosis (NDAL) harboring t(11;14), and of a BCMA\u002FCD3 bispecific antibody in patients with NDAL without t(11;14). In addition, this study seeks to explore a chemotherapy-free treatment strategy based on t(11;14)-guided genetic stratification.",[556],"Multiple Myeloma (MM)",[187,558,559],"Sonrotoclax","t(11;14)",{"date":192,"type":33},{"date":35,"type":22},{"date":455,"type":22},{"name":39,"class":40},""]