[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Xuzhou Medical University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":310},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,44,71,101,127,146,167,188,206,229,251,270,291],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100534884","phase-3-safety-and-efficacy-of-iguratimod-in-the-treatment-of-chronic-gvhd-100534884",false,"NCT06244628","Safety and Efficacy of Iguratimod in the Treatment of Chronic GVHD","Safety and Efficacy of Iguratimod in the Treatment of Chronic GVHD After Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. Patients aged ≥18 years who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT), regardless of gender.\n2. Those with persistent manifestations of chronic graft-versus-host disease (cGVHD) and suitable for systemic treatment.\n3. Previously received at least 1 but not more than 5 lines of systemic treatment for cGVHD.\n4. Corticosteroid therapy dose stable for the two weeks before screening; or, if taking prednisone or an equivalent dose of other corticosteroids at a dose \\>0.5mg\u002Fkg\u002Fday for four weeks, with ongoing cGVHD manifestations and no improvement; or, if two attempts to taper steroids to a lower dose have failed, and it is necessary to increase the prednisone dose to \\>0.25mg\u002Fkg\u002Fday or an equivalent dose.\n5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0\\~1.\n6. Anticipated survival of more than 12 months.\n\n   General criteria:\n7. Serum pregnancy test negative for women of childbearing age during the screening period.\n8. Sexually active women of childbearing age participating in this study must agree to contraception during the trial and after the last dose of medication.\n\nExclusion Criteria:\n\n1. Patients who have received experimental treatment for systemic cGVHD within the 28 days prior to enrollment, which was effective and could completely alleviate immunosuppression.\n2. Blood cancer relapse (according to the corresponding criteria for relapse of the primary blood cancer) or post-transplant lymphoproliferative disease at the time of screening.\n\n   Laboratory tests:\n3. Absolute neutrophil count (ANC) \\\u003C1.5×10\\^9\u002FL (excluding GVHD as the cause).\n4. Platelet count \\\u003C50×10\\^9\u002FL (excluding GVHD as the cause).\n5. Alanine aminotransferase (ALT) \\>3 times the upper limit of normal (ULN), aspartate aminotransferase (AST) \\>3×ULN (excluding GVHD as the cause).\n6. Total bilirubin (TBIL) \\>1.5×ULN (excluding GVHD as the cause).\n7. Creatinine clearance CrCl \\\u003C60 mL\u002Fmin (Cockcroft-Gault formula).\n\n   General criteria:\n8. Pregnant or lactating women.\n9. History of serious illness or other evidence indicating a serious illness, or any other condition that the investigator believes may make the subject unsuitable for this study.\n\n   * History of severe cardiovascular disease \\[New York Heart Association (NYHA) functional class III or IV\\], including but not limited to ventricular arrhythmias requiring clinical intervention, uncontrolled hypertension (systolic blood pressure ≥160mmHg and\u002For diastolic blood pressure ≥100mmHg); within 6 months prior to enrollment, there is unstable angina, acute coronary syndrome, congestive heart failure, stroke, or other cardiovascular events of class III or above; at screening, NYHA functional class ≥II or left ventricular ejection fraction (LVEF) \\\u003C50% on echocardiography.\n   * Unable to take oral medications, with severe (NCI CTCAE v5.0 ≥ grade 3) chronic gastrointestinal dysfunction, the presence of malabsorption syndrome, or any other condition affecting gastrointestinal absorption.\n   * History of clear neurological or psychiatric disorders (including epilepsy or dementia), currently suffering from psychiatric disorders, or judged by the investigator to be non-compliant and unsuitable for participation in the study.\n   * History of other severe (NCI CTCAE v5.0 ≥ grade 3) systemic diseases, deemed unsuitable for participation in the clinical trial by the investigator.\n10. Other circumstances in which the investigator deems it inappropriate to participate in this study.",true,"ALL","18 Years","60 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This is a randomized, single-center phase 3 clinical trial without blinding. Iguratimod, as a rheumatoid arthritis medication, is used to treat autoimmune diseases such as Sjögren's syndrome. It has acceptable side effects, good clinical availability, and is cost-effective. The investigators plan to recruit participants for a clinical trial to evaluate the efficacy and safety of Iguratimod in the treatment of chronic GVHD.",[28],"cGVHD",[30,28],"Iguratimod","RECRUITING","2026-05-26",{"date":34,"type":35},"2026-05-27","ACTUAL",{"date":37,"type":35},"2024-01-10",{"date":39,"type":22},"2028-12-31",{"name":41,"class":42},"Xuzhou Medical University","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":43},"100621395","phase-1-clinical-study-of-anti-cll1-cd33-nkg2d-bicephali-car-t-for-relapsedrefractory-acute-myeloid-leukemia-100621395","NCT07370064","Clinical Study of Anti-CLL1-CD33-NKG2D Bicephali CAR-T for Relapsed\u002FRefractory Acute Myeloid Leukemia","A Phase I\u002FII Study to Evaluate the Safety and Efficacy of Anti-CLL1-CD33-NKG2D Bicephali CAR-T Cells in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","AML CAR-T","Inclusion Criteria:\n\nAge: Patients must be ≥18 years old. Diagnosis: Confirmed diagnosis of relapsed or refractory acute myeloid leukemia (AML) as per the World Health Organization (WHO) criteria.\n\nPrior Treatment: Must have failed at least one prior line of chemotherapy or targeted therapy.\n\nPerformance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n\nAdequate Organ Function:\n\nHematologic function: Absolute neutrophil count (ANC) ≥ 1,000\u002FμL, platelet count ≥ 50,000\u002FμL, and hemoglobin ≥ 8 g\u002FdL (without transfusion support).\n\nRenal function: Serum creatinine ≤ 1.5 x upper limit of normal (ULN). Liver function: Total bilirubin ≤ 2 x ULN, AST\u002FALT ≤ 2.5 x ULN. Informed Consent: The patient must be willing and able to provide written informed consent to participate in the study.\n\nEligible for Apheresis: Patients must be able to undergo the apheresis procedure to collect T cells for CAR-T cell modification.\n\nExclusion Criteria:\n\nActive Central Nervous System (CNS) Leukemia: Presence of active leukemia in the CNS.\n\nPregnancy or Breastfeeding: Female patients who are pregnant or breastfeeding. Severe Active Infections: Active and uncontrolled infections, including HIV, hepatitis B or C, or any other severe systemic infections.\n\nOther Malignancies: History of another malignancy (except for treated, localized cancers such as basal cell carcinoma) within the past 5 years.\n\nAutoimmune Diseases: Active autoimmune diseases requiring systemic immunosuppressive therapy.\n\nHistory of Severe Cytokine Release Syndrome (CRS): Any history of severe CRS or neurological toxicity following prior CAR-T cell therapy.\n\nAllergy to Apheresis or CAR-T Cell Components: Known hypersensitivity to any of the components involved in the apheresis or CAR-T cell therapy procedure.\n\nUncontrolled Systemic Disease: Uncontrolled comorbid conditions, such as severe cardiovascular disease, uncontrolled hypertension, or severe pulmonary conditions.\n\nConcurrent Participation in Another Clinical Trial: Participation in another clinical trial for AML or related conditions that may interfere with this study's treatment and outcomes.\n\nInability to Comply: Inability to comply with study procedures or follow-up requirements as per the investigator's judgment.","70 Years",{"count":21,"type":22},[55,56],"PHASE1","PHASE2","This study is a clinical trial designed to evaluate the safety and efficacy of a new type of CAR-T cell therapy for patients with relapsed\u002Frefractory acute myeloid leukemia (AML). The treatment involves modifying the patient's own T cells to target and eliminate leukemia cells more effectively. This is a cutting-edge therapy using anti-CLL1-CD33-NKG2D Bicephali CAR-T cells.\n\nThe primary goal of this study is to determine whether this treatment can improve survival and reduce the symptoms of AML in patients whose disease has not responded to standard treatments. Participants will be closely monitored for side effects and the overall effectiveness of the treatment.\n\nEligibility for this study includes patients who have been diagnosed with relapsed or refractory AML and have not had success with previous therapies. Participation in this study will provide access to an experimental treatment that may offer benefits beyond current treatment options, but also comes with risks.\n\nPatients, their families, and healthcare providers will be provided with full information about the procedure, potential benefits, and risks, and they will have the opportunity to ask questions before deciding whether to participate.",[59],"AML (Acute Myeloid Leukemia)",[61],"CAR-T","NOT_YET_RECRUITING","2026-01-18",{"date":65,"type":35},"2026-01-27",{"date":67,"type":22},"2026-01-31",{"date":69,"type":22},"2029-01-31",{"name":41,"class":42},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":83,"conditions":84,"keywords":89,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":98,"leadSponsor":100,"locationsCount":4},"100614530","early-phase-1-car-t-cell-efficacy-with-molecular-imaging-in-multiple-myeloma-100614530","NCT07280793","CAR-T Cell Efficacy With Molecular Imaging in Multiple Myeloma","Visualizing CAR-T Cell Therapy in Multiple Myeloma Using a BCMA-Targeted PET Probe","Inclusion Criteria:\n\n* \\*\\*Inclusion Criteria\\*\\*\n\n  1. Subjects must voluntarily sign the informed consent form and be able to complete the trial per the protocol requirements.\n  2. Age 18 years or older, regardless of gender.\n  3. Diagnosed with multiple myeloma and scheduled to receive anti-BCMA CAR-T cell therapy.\n  4. ECOG performance status of 0-2; with a life expectancy of not less than 3 months.\n  5. Female subjects of childbearing potential must have a negative serum pregnancy test prior to enrollment.\n  6. For female subjects of childbearing potential or male subjects with partners of childbearing potential, agreement to remain abstinent or use one or more forms of contraception with a failure rate of \\\u003C1% per year during the study period and for at least one year after the study completion.\n\nExclusion Criteria:\n\n* \\*\\*Exclusion Criteria\\*\\*\n\n  1. Participation in another interventional clinical trial, concurrently or within 28 days prior to the first dose in this study. Participation in non-interventional trials is permitted.\n  2. History of hypersensitivity to any component of the imaging agent or antibodies, or a known allergic predisposition.\n  3. Inability to undergo PET\u002FCT imaging, such as due to claustrophobia or emotional instability.\n  4. Current use of anticoagulant therapy or anticipated requirement for such therapy during the study period.\n  5. Known allergic or hypersensitivity reactions to biological products or any excipient of the 68Ga-NOTA-BCMA molecular probe.\n  6. Active hepatitis B or C infection, or seropositivity for human immunodeficiency virus (HIV) antibody or Treponema pallidum antibody.\n  7. Pregnancy, lactation, or intention to become pregnant during the trial period.\n  8. Any other condition deemed by the investigator to render the subject unsuitable for trial participation.","75 Years",{"count":80,"type":22},10,[82],"EARLY_PHASE1","⁶⁸Ga-NOTA-BCMA is a novel, targeted PET tracer under clinical investigation. It is designed to provide a non-invasive method for monitoring the biodistribution and persistence of BCMA CAR-T cells in patients. Preclinical data robustly support its specific binding, favorable pharmacokinetics, and excellent safety profile, warranting its advancement into clinical studies.",[85,86,87,88],"Non-invasive CAR-T Cell Monitoring","BCMA-targeted PET Imaging","CAR-T Cell Biodistribution and Persistence","GMP-compliant Radiopharmaceutical Preparation",[90,91,92,93],"⁶⁸Ga-NOTA-BCMA","BCMA CAR-T cell imaging","BCMA PET tracer","Radiolabeled BCMA peptide","2025-12-16",{"date":96,"type":35},"2025-12-17",{"date":96,"type":22},{"date":99,"type":22},"2027-12-30",{"name":41,"class":42},{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":109,"targetDuration":4,"studyType":23,"phases":111,"briefSummary":112,"conditions":113,"keywords":116,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":4},"100598395","phase-2-car-t-vs-auto-sct-which-works-better-for-new-myeloma-patients-100598395","NCT07070934","CAR-T vs. Auto-SCT: Which Works Better for New Myeloma Patients?","A Multicenter, Open-label, Randomized Controlled Trial Comparing Anti-BCMA CAR-T Cell Therapy Versus Autologous Hematopoietic Stem Cell Transplantation in Transplant-eligible Patients With Newly Diagnosed Multiple Myeloma","ASCTvsCAR-T","Inclusion Criteria:\n\n1. Age between 18 and 70 years (inclusive);\n2. Estimated life expectancy of more than 12 weeks;\n3. Diagnosis of multiple myeloma confirmed by physical examination, pathological evaluation, laboratory tests, and imaging studies;\n4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels less than 3 times the upper limit of normal (ULN);\n5. Karnofsky Performance Status (KPS) score \\> 50%.\n6. Eligible for ASCT.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women, or women planning to become pregnant within the next six months;\n2. Transduction efficiency of targeted lymphocytes \\\u003C10%, or expansion fold \\\u003C5× under CD3\u002FCD28 co-stimulation, as determined by feasibility screening;\n3. History of severe allergies or hypersensitivity, especially to interleukin-2 (IL-2);\n4. Significant dysfunction of vital organs including the heart, lungs, or brain;\n5. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study",{"count":110,"type":22},60,[56],"This is a prospective study comparing anti-BCMA CAR-T to autologous hematopoietic stem cell transplantation alone in the treatment of newly diagnosed multiple myeloma patients.",[114,115],"Multiple Myeloma","Newly Diagnosed",[114,117,118,61],"Eligible for ASCT","ASCT","2025-07-08",{"date":121,"type":35},"2025-07-17",{"date":123,"type":22},"2025-07-15",{"date":125,"type":22},"2028-07-31",{"name":41,"class":42},{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":61,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":134,"targetDuration":4,"studyType":23,"phases":136,"briefSummary":138,"conditions":139,"keywords":140,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":142,"startDateStruct":143,"completionDateStruct":144,"leadSponsor":145,"locationsCount":4},"100598397","a-study-of-anti-bcma-car-t-therapy-in-newly-diagnosed-myeloma-patients-who-are-transplant-ineligible-100598397","NCT07070960","A Study of Anti-BCMA CAR-T Therapy in Newly Diagnosed Myeloma Patients Who Are Transplant-ineligible","A Multicenter, Open-label, Single-arm Clinical Study of Anti-BCMA CAR-T Cell Therapy in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma","Inclusion Criteria:\n\n1. Age between 18 and 70 years (inclusive);\n2. Estimated life expectancy of more than 12 weeks;\n3. Diagnosis of multiple myeloma confirmed by physical examination, pathological evaluation, laboratory tests, and imaging studies;\n4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels less than 3 times the upper limit of normal (ULN);\n5. Karnofsky Performance Status (KPS) score \\> 50%.\n6. Ineligible for ASCT.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women, or women planning to become pregnant within the next six months;\n2. Transduction efficiency of targeted lymphocytes \\\u003C10%, or expansion fold \\\u003C5× under CD3\u002FCD28 co-stimulation, as determined by feasibility screening;\n3. History of severe allergies or hypersensitivity, especially to interleukin-2 (IL-2);\n4. Significant dysfunction of vital organs including the heart, lungs, or brain;\n5. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study",{"count":135,"type":22},35,[137],"NA","This is a prospective study of anti-BCMA CAR-T in transplant-ineligible patients with newly diagnosed multiple myeloma.",[114,115],[114,141,61],"transplant-ineligible",{"date":121,"type":35},{"date":123,"type":22},{"date":125,"type":22},{"name":41,"class":42},{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":107,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":153,"targetDuration":4,"studyType":23,"phases":154,"briefSummary":155,"conditions":156,"keywords":158,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":43},"100590165","phase-2-comparing-asct-followed-by-anti-bcma-car-t-vs-asct-alone-in-ndmm-patients-eligible-for-asct-100590165","NCT06963866","Comparing ASCT Followed by Anti-BCMA CAR-T vs. ASCT Alone in NDMM Patients Eligible for ASCT","A Multicenter, Open-Label, Randomized, Controlled Study of Autologous Stem Cell Transplantation Followed by Anti-BCMA CAR-T Therapy Versus ASCT Alone in Transplant-Eligible Patients With Newly Diagnosed Multiple Myeloma","Inclusion Criteria:\n\n1. Age between 18 and 70 years (inclusive);\n2. Estimated life expectancy of more than 12 weeks;\n3. Diagnosis of multiple myeloma confirmed by physical examination, pathological evaluation, laboratory tests, and imaging studies;\n4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels less than 3 times the upper limit of normal (ULN);\n5. Karnofsky Performance Status (KPS) score \\> 50%.\n6. Eligible for ASCT.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women, or women planning to become pregnant within the next six months;\n2. Transduction efficiency of targeted lymphocytes \\\u003C10%, or expansion fold \\\u003C5× under CD3\u002FCD28 co-stimulation, as determined by feasibility screening;\n3. History of severe allergies or hypersensitivity, especially to interleukin-2 (IL-2);\n4. Significant dysfunction of vital organs including the heart, lungs, or brain;\n5. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.",{"count":110,"type":22},[56],"This is a prospective study comparing autologous hematopoietic stem cell transplantation followed by anti-BCMA CAR-T to autologous hematopoietic stem cell transplantation alone in the treatment of newly diagnosed multiple myeloma patients.",[157],"Multiple Myeloma, Newly Diagnosed",[114,117,118,61],"2025-04-30",{"date":161,"type":35},"2025-05-09",{"date":163,"type":22},"2025-05-01",{"date":165,"type":22},"2028-04-30",{"name":41,"class":42},{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":175,"targetDuration":4,"studyType":23,"phases":177,"briefSummary":178,"conditions":179,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":4},"100586270","phase-1-efficacy-of-sequential-bcma-car-t-cell-therapy-following-autologous-hematopoietic-stem-cell-transplantation-in-transplant-eligible-newly-diagnosed-multiple-myeloma-100586270","NCT06913192","Efficacy of Sequential BCMA CAR-T Cell Therapy Following Autologous Hematopoietic Stem Cell Transplantation in Transplant-eligible Newly Diagnosed Multiple Myeloma","A Single-Center, Open-Label, Single-Arm Clinical Study of Sequential Anti-BCMA CAR-T Cell Therapy Following Autologous Hematopoietic Stem Cell Transplantation in Transplant-Eligible Newly Diagnosed Multiple Myeloma","AUTO-CAR-T","Inclusion Criteria:\n\nAge between 18 and 70 years; Estimated life expectancy \\> 12 weeks; Diagnosis of multiple myeloma confirmed by physical examination, histopathology, laboratory tests, and imaging; Liver function: ALT and AST \\\u003C 3 times the upper limit of normal; Karnofsky Performance Status (KPS) score \\> 50%; No severe dysfunction of major organs such as the liver or heart; Willingness to undergo ASCT and CAR-T cell therapy for multiple myeloma; Ability to provide peripheral venous blood and no contraindications to leukapheresis; Ability to understand the study and sign a written informed consent voluntarily.\n\nExclusion Criteria:\n\nPregnant or lactating women, or those planning pregnancy within six months; Patients with infectious diseases, including HIV infection or active tuberculosis; Patients with active hepatitis B or C virus infection; Pre-screening indicates peripheral blood T cell transduction efficiency \\\u003C10% or expansion fold \\\u003C5× under CD3\u002FCD28 co-stimulation; Patients with abnormal vital signs or unable to cooperate with the procedures; Patients with psychiatric or psychological disorders that impair compliance or assessment; Patients with a history of severe allergies or hypersensitivity, particularly to interleukin-2 (IL-2); Patients with systemic or severe local infections requiring anti-infective therapy; Patients with significant dysfunction of vital organs such as the heart, lungs, or brain; Any other condition deemed unsuitable for participation by the investigator.",{"count":176,"type":22},50,[55],"1. Study Title A Single-Center, Open-Label, Single-Arm Clinical Study of Sequential Anti-BCMA CAR-T Cell Therapy Following Autologous Hematopoietic Stem Cell Transplantation in Transplant-Eligible Newly Diagnosed Multiple Myeloma\n2. Study Objective This study aims to evaluate the safety and efficacy of sequential anti-BCMA CAR-T cell therapy following autologous hematopoietic stem cell transplantation (ASCT) in transplant-eligible patients with newly diagnosed multiple myeloma (NDMM), in order to provide evidence for optimizing treatment strategies in this population.\n3. Study Design This is a single-center, open-label, single-arm clinical study. A total of 50 patients with newly diagnosed multiple myeloma who meet the inclusion criteria will be enrolled. All participants will receive a standardized treatment regimen and undergo regular follow-up for efficacy and safety assessments.\n4. Study Population and Eligibility Criteria (1) Inclusion Criteria Age between 18 and 70 years;\n\nEstimated life expectancy \\> 12 weeks;\n\nDiagnosis of multiple myeloma confirmed by physical examination, histopathology, laboratory tests, and imaging;\n\nLiver function: ALT and AST \\\u003C 3 times the upper limit of normal;\n\nKarnofsky Performance Status (KPS) score \\> 50%;\n\nNo severe dysfunction of major organs such as the liver or heart;\n\nWillingness to undergo ASCT and CAR-T cell therapy for multiple myeloma;\n\nAbility to provide peripheral venous blood and no contraindications to leukapheresis;\n\nAbility to understand the study and sign a written informed consent voluntarily.\n\n(2) Exclusion Criteria Pregnant or lactating women, or those planning pregnancy within six months;\n\nPatients with infectious diseases, including HIV infection or active tuberculosis;\n\nPatients with active hepatitis B or C virus infection;\n\nPre-screening indicates peripheral blood T cell transduction efficiency \\\u003C10% or expansion fold \\\u003C5× under CD3\u002FCD28 co-stimulation;\n\nPatients with abnormal vital signs or unable to cooperate with the procedures;\n\nPatients with psychiatric or psychological disorders that impair compliance or assessment;\n\nPatients with a history of severe allergies or hypersensitivity, particularly to interleukin-2 (IL-2);\n\nPatients with systemic or severe local infections requiring anti-infective therapy;\n\nPatients with significant dysfunction of vital organs such as the heart, lungs, or brain;\n\nAny other condition deemed unsuitable for participation by the investigator.\n\n5\\. Treatment Protocol All enrolled patients will receive three cycles of induction therapy using either the DVRd regimen (Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone) or the DKRd regimen (Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone).\n\nFollowing induction, patients will undergo high-dose melphalan conditioning followed by autologous hematopoietic stem cell transplantation. On Day 5 after stem cell reinfusion, patients will receive anti-BCMA CAR-T cell infusion.\n\nAfter CAR-T therapy, patients will enter the maintenance phase with lenalidomide monotherapy or lenalidomide in combination with bortezomib until disease progression or intolerable toxicity occurs.",[114],"2025-03-29",{"date":182,"type":35},"2025-04-06",{"date":184,"type":22},"2025-04-01",{"date":186,"type":22},"2028-02-28",{"name":41,"class":42},{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":196,"targetDuration":4,"studyType":23,"phases":198,"briefSummary":199,"conditions":200,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":201,"startDateStruct":202,"completionDateStruct":203,"leadSponsor":205,"locationsCount":4},"100586269","phase-1-car-t-cell-therapy-combined-with-allogeneic-hematopoietic-stem-cell-transplantation-for-relapsed-or-refractory-multiple-myeloma-100586269","NCT06913179","CAR-T Cell Therapy Combined With Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed or Refractory Multiple Myeloma","CAR-T Cell Therapy Combined With Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed\u002FRefractory Multiple Myeloma","CAR-T-allo","Inclusion Criteria:\n\nAge between 18 and 70 years; Estimated life expectancy of more than 12 weeks; Diagnosis of multiple myeloma confirmed by physical examination, pathology, laboratory tests, and imaging studies; Patients with refractory multiple myeloma; Patients with relapsed multiple myeloma; ALT and AST \\\u003C 3 times the upper limit of normal; Total bilirubin \\\u003C 2.0 mg\u002FdL; Karnofsky Performance Status (KPS) \\> 50%; No severe dysfunction of major organs such as liver, kidney, or heart; Prior failure of autologous or allogeneic hematopoietic stem cell transplantation; Ineligible for stem cell transplantation or patients who declined transplantation due to other constraints; Voluntarily willing to receive CAR-T cell therapy for B cell-derived hematologic malignancies; Suitable for peripheral venous blood collection with no contraindications to leukapheresis; Able to understand and sign a written informed consent form.\n\nExclusion Criteria:\n\nPregnant or lactating women, or women planning pregnancy within 6 months; Presence of infectious diseases (e.g., HIV infection, active tuberculosis); Active hepatitis B or C virus infection; Pre-screening indicates peripheral blood T-cell transduction efficiency \\\u003C 10% or expansion fold \\\u003C 5× under CD3\u002FCD28 co-stimulation; Abnormal vital signs or inability to cooperate with treatment procedures; Presence of psychiatric or psychological disorders that affect treatment compliance or outcome assessment; History of severe allergy or hypersensitivity, particularly to interleukin-2 (IL-2); Systemic or localized severe infections requiring anti-infective therapy; Significant dysfunction of critical organs such as heart, lung, brain, or kidney; Patients with severe autoimmune diseases; Any other conditions deemed unsuitable for enrollment by the investigator.",{"count":197,"type":22},30,[55],"1. Study Title CAR-T Cell Therapy Combined with Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed or Refractory Multiple Myeloma\n2. Study Objective This study aims to evaluate the safety and efficacy of CAR-T cell therapy followed by allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with relapsed or refractory multiple myeloma. The goal is to explore a novel treatment strategy for this high-risk patient population.\n3. Study Design This is a single-center, open-label, single-arm clinical study. A total of 30 patients with relapsed or refractory multiple myeloma will be enrolled. All participants will receive standardized CAR-T cell therapy followed by allo-HSCT and will undergo systematic observation and follow-up to assess therapeutic efficacy and safety.\n4. Sample Size A total of 30 patients will be enrolled in this study.\n5. Eligibility Criteria (1) Inclusion Criteria Age between 18 and 70 years; Estimated life expectancy of more than 12 weeks; Diagnosis of multiple myeloma confirmed by physical examination, pathology, laboratory tests, and imaging studies; Patients with refractory multiple myeloma; Patients with relapsed multiple myeloma; ALT and AST \\\u003C 3 times the upper limit of normal; Total bilirubin \\\u003C 2.0 mg\u002FdL; Karnofsky Performance Status (KPS) \\> 50%; No severe dysfunction of major organs such as liver, kidney, or heart; Prior failure of autologous or allogeneic hematopoietic stem cell transplantation; Ineligible for stem cell transplantation or patients who declined transplantation due to other constraints; Voluntarily willing to receive CAR-T cell therapy for B cell-derived hematologic malignancies; Suitable for peripheral venous blood collection with no contraindications to leukapheresis; Able to understand and sign a written informed consent form.\n\n(2) Exclusion Criteria Pregnant or lactating women, or women planning pregnancy within 6 months; Presence of infectious diseases (e.g., HIV infection, active tuberculosis); Active hepatitis B or C virus infection; Pre-screening indicates peripheral blood T-cell transduction efficiency \\\u003C 10% or expansion fold \\\u003C 5× under CD3\u002FCD28 co-stimulation; Abnormal vital signs or inability to cooperate with treatment procedures; Presence of psychiatric or psychological disorders that affect treatment compliance or outcome assessment; History of severe allergy or hypersensitivity, particularly to interleukin-2 (IL-2); Systemic or localized severe infections requiring anti-infective therapy; Significant dysfunction of critical organs such as heart, lung, brain, or kidney; Patients with severe autoimmune diseases; Any other conditions deemed unsuitable for enrollment by the investigator.\n\n6\\. Treatment Protocol All enrolled patients will first receive CAR-T cell therapy. Patients who achieve complete remission (CR) following CAR-T infusion will subsequently undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT) based on clinical assessment. The entire treatment process will be standardized and closely monitored, with follow-up evaluations focusing on adverse events, engraftment success, relapse risk, and overall survival.",[114],{"date":182,"type":35},{"date":184,"type":22},{"date":204,"type":22},"2028-03-31",{"name":41,"class":42},{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":213,"targetDuration":4,"studyType":23,"phases":214,"briefSummary":215,"conditions":216,"keywords":217,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":43},"100574430","phase-1-safety-and-efficacy-of-anti-bcmafcrl5-car-t-cell-therapy-in-treating-relapsed-and-refractory-multiple-myeloma-rr-mm-100574430","NCT06759181","Safety and Efficacy of Anti-BCMA\u002FFcRL5 CAR-T Cell Therapy in Treating Relapsed and Refractory Multiple Myeloma (R\u002FR MM)","Efficacy and Safety Study of Anti-BCMA\u002FFcRL5 CAR-T Cells in Subjects With Relapsed and Refractory Multiple Myeloma","Inclusion Criteria:\n\nAge is 18\\~70 years old; Expected survival period of\\>12 weeks; Multiple myeloma was diagnosed by physical examination, pathological examination, laboratory examination and imaging; Patients with refractory multiple myeloma; Patients with multiple myeloma recurrence; ALT and AST \\\u003C3 times normal; bilirubin \\\u003C2.0mg \u002F dl; Quality of survival score (KPS)\\> 50%; The patient has no serious heart, liver, kidney and other diseases; Recurrence or no disease remission after hematopoietic stem cell transplantation or cellular immunotherapy; Is not suitable for stem cell transplantation conditions or to abandon transplantation due to conditional restrictions; Blood can be obtained intravenously, without other contraindications to leukapheresis; Understand and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\nWomen who are pregnant or breastfeeding, or who have a pregnancy plan within six months; Infectious diseases (such as HIV, active tuberculosis, etc.); Active hepatitis B or hepatitis C infection; Feasibility assessment screening demonstrated \\\u003C10% transfection of targeted lymphocytes or underamplification under CD3 \u002F CD28 costimulation (\\\u003C5-fold); Abnormal vital signs, and unable to cooperate with the examination; Have mental or mental illness who cannot cooperate with the treatment and efficacy evaluation; Highly allergic constitution or have a history of severe allergies, especially allergic to IL-2; Subjects with a systemic infection or a severe local infection requiring anti-infective treatment; Subjects with severe autoimmune disease; The doctor believes there were other reasons for inclusion",{"count":21,"type":22},[55,56],"This is an open label, single-arm, Phase 2 study to evaluate the efficacy and safety of Anti-BCMA\u002FFcRL5 CAR-T in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture. Anti-BCMAFcRL5 chimeric antigen receptor (CAR) modified T cells. Prior to Anti-BCMA\u002FFcRL5 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.",[114],[218,219,220],"multiple myeloma","BCMA","FcRL5","2024-12-29",{"date":223,"type":35},"2025-01-06",{"date":225,"type":22},"2024-12-31",{"date":227,"type":22},"2027-12-31",{"name":41,"class":42},{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":236,"targetDuration":4,"studyType":23,"phases":237,"briefSummary":238,"conditions":239,"keywords":241,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":4},"100547685","phase-1-safety-and-efficacy-of-treg-cell-in-the-treatment-of-gvhd-100547685","NCT06411184","Safety and Efficacy of Treg Cell in the Treatment of GVHD","Safety and Efficacy of Treg Cell in the Treatment of GVHD After Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. Patients aged ≥18 years who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT), regardless of gender.\n2. Those with persistent manifestations of graft-versus-host disease (GVHD) and suitable for systemic treatment.\n3. Previously received at least 1 but not more than 5 lines of systemic treatment for GVHD.\n4. Corticosteroid therapy dose stable for the two weeks before screening; or, if taking prednisone or an equivalent dose of other corticosteroids at a dose \\>0.5mg\u002Fkg\u002Fday for four weeks, with ongoing GVHD manifestations and no improvement; or, if two attempts to taper steroids to a lower dose have failed, and it is necessary to increase the prednisone dose to \\>0.25mg\u002Fkg\u002Fday or an equivalent dose.\n5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0\\~1.\n6. Anticipated survival of more than 12 months.\n\n   General criteria:\n7. Serum pregnancy test negative for women of childbearing age during the screening period.\n8. Sexually active women of childbearing age participating in this study must agree to contraception during the trial and after the last dose of medication.\n\nExclusion Criteria:\n\n1. Patients who have received experimental treatment for systemic GVHD within the 28 days prior to enrollment, which was effective and could completely alleviate immunosuppression.\n2. Blood cancer relapse (according to the corresponding criteria for relapse of the primary blood cancer) or post-transplant lymphoproliferative disease at the time of screening.\n\n   Laboratory tests:\n3. Absolute neutrophil count (ANC) \\\u003C1.5×10\\^9\u002FL (excluding GVHD as the cause).\n4. Platelet count \\\u003C50×10\\^9\u002FL (excluding GVHD as the cause).\n5. Alanine aminotransferase (ALT) \\>3 times the upper limit of normal (ULN), aspartate aminotransferase (AST) \\>3×ULN (excluding GVHD as the cause).\n6. Total bilirubin (TBIL) \\>1.5×ULN (excluding GVHD as the cause).\n7. Creatinine clearance CrCl \\\u003C60 mL\u002Fmin (Cockcroft-Gault formula).\n\n   General criteria:\n8. Pregnant or lactating women.\n9. History of serious illness or other evidence indicating a serious illness, or any other condition that the investigator believes may make the subject unsuitable for this study.\n\n   * History of severe cardiovascular disease \\[New York Heart Association (NYHA) functional class III or IV\\], including but not limited to ventricular arrhythmias requiring clinical intervention, uncontrolled hypertension (systolic blood pressure ≥160mmHg and\u002F or diastolic blood pressure ≥100mmHg); within 6 months prior to enrollment, there is unstable angina, acute coronary syndrome, congestive heart failure, stroke, or other cardiovascular events of class III or above; at screening, NYHA functional class ≥II or left ventricular ejection fraction (LVEF) \\\u003C50% on echocardiography.\n   * Unable to take oral medications, with severe (NCI CTCAE v5.0 ≥ grade 3) chronic gastrointestinal dysfunction, the presence of malabsorption syndrome, or any other condition affecting gastrointestinal absorption.\n   * History of clear neurological or psychiatric disorders (including epilepsy or dementia), currently suffering from psychiatric disorders, or judged by the investigator to be non-compliant and unsuitable for participation in the study.\n   * History of other severe (NCI CTCAE v5.0 ≥ grade 3) systemic diseases, deemed unsuitable for participation in the clinical trial by the investigator.\n10. Other circumstances in which the investigator deems it inappropriate to participate in this study.",{"count":21,"type":22},[55,56],"This is a randomized, single-center phase 1\u002F2a clinical trial without blinding. Regulatory T cells (Tregs) have shown potential in treating various immune-related diseases, including autoimmune disorders, transplant rejection, and inflammatory diseases. The investigators plan to recruit participants for a clinical trial to evaluate the efficacy and safety of autologous Tregs in the treatment of GVHD.",[240],"GVHD",[242,240],"Regulatory T-Lymphocytes","2024-05-07",{"date":245,"type":35},"2024-05-13",{"date":247,"type":22},"2024-06-01",{"date":249,"type":22},"2027-05-31",{"name":41,"class":42},{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":258,"targetDuration":4,"studyType":23,"phases":259,"briefSummary":260,"conditions":261,"keywords":262,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":267,"leadSponsor":269,"locationsCount":43},"100531166","phase-1-safety-and-efficacy-of-anti-fcrl5-car-t-cell-therapy-in-treating-relapsed-and-refractory-multiple-myeloma-rr-mm-100531166","NCT06196255","Safety and Efficacy of Anti-FcRL5 CAR-T Cell Therapy in Treating Relapsed and Refractory Multiple Myeloma (R\u002FR MM)","Efficacy and Safety Study of Anti-FcRL5 CAR-T Cells in Subjects With Relapsed and Refractory Multiple Myeloma","Inclusion Criteria:\n\nThe set subject inclusion criteria include multiple documents of multiple myeloma, no effective treatment options (e. g. autologous or allogeneic stem cell transplantation) and limited outcome (\\\u003C2 years) with existing therapies, as follows:\n\n1. Age is 18\\~70 years old;\n2. Expected survival period of\\>12 weeks;\n3. Multiple myeloma was diagnosed by physical examination, pathological examination, laboratory examination and imaging;\n4. Patients with refractory multiple myeloma;\n5. Patients with multiple myeloma recurrence;\n6. ALT and AST \\\u003C3 times normal; bilirubin \\\u003C2.0mg \u002F dl;\n7. Quality of survival score (KPS)\\> 50%;\n8. The patient has no serious heart, liver, kidney and other diseases;\n9. Recurrence or no disease remission after hematopoietic stem cell transplantation or cellular immunotherapy;\n10. Is not suitable for stem cell transplantation conditions or to abandon transplantation due to conditional restrictions;\n11. Blood can be obtained intravenously, without other contraindications to leukapheresis;\n12. Understand and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Women who are pregnant or breastfeeding, or who have a pregnancy plan within six months;\n2. Infectious diseases (such as HIV, active tuberculosis, etc.);\n3. Active hepatitis B or hepatitis C infection;\n4. Feasibility assessment screening demonstrated \\\u003C10% transfection of targeted lymphocytes or underamplification under CD3 \u002F CD28 costimulation (\\\u003C5-fold);\n5. Abnormal vital signs, and unable to cooperate with the examination;\n6. Have mental or mental illness who cannot cooperate with the treatment and efficacy evaluation;\n7. Highly allergic constitution or have a history of severe allergies, especially allergic to IL-2;\n8. Subjects with a systemic infection or a severe local infection requiring anti-infective treatment;\n9. Subjects with severe autoimmune disease;\n10. The doctor believes there were other reasons for inclusion",{"count":21,"type":22},[55,56],"This is an open label, single-arm, Phase 2 study to evaluate the efficacy and safety of Anti-FcRL5 CAR-T in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture. Anti-FcRL5 chimeric antigen receptor (CAR) modified T cells. Prior to Anti-FcRL5 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.",[114],[114,220],"2023-12-25",{"date":265,"type":35},"2024-01-09",{"date":263,"type":35},{"date":268,"type":22},"2028-01-01",{"name":41,"class":42},{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":61,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":277,"targetDuration":4,"studyType":23,"phases":278,"briefSummary":279,"conditions":280,"keywords":281,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":43},"100526282","phase-1-safety-and-efficacy-of-april-baff-bicephali-car-t-in-relapsed-refractory-multiple-myeloma-100526282","NCT06132711","Safety and Efficacy of APRIL-BAFF-Bicephali CAR-T in Relapsed, Refractory Multiple Myeloma","Safety and Efficacy of APRIL-BAFF-Bicephali CAR-T in Relapsed, Refractory Multiple Myeloma-A Single-center, Open-label, Single-arm Clinical Study","Inclusion Criteria:\n\nThe set subject inclusion criteria include multiple documents of multiple myeloma, no effective treatment options (e. g. autologous or allogeneic stem cell transplantation) and limited outcome (\\\u003C2 years) with existing therapies, as follows:\n\n1. Age is 18\\~70 years old;\n2. Expected survival period of\\>12 weeks;\n3. Multiple myeloma was diagnosed by physical examination, pathological examination, laboratory examination and imaging;\n4. Patients with refractory multiple myeloma;\n5. Patients with multiple myeloma recurrence;\n6. ALT and AST \\\u003C3 times normal; bilirubin \\\u003C2.0mg \u002F dl;\n7. Quality of survival score (KPS)\\> 50%;\n8. The patient has no serious heart, liver, kidney and other diseases;\n9. Recurrence or no disease remission after hematopoietic stem cell transplantation or cellular immunotherapy;\n10. Is not suitable for stem cell transplantation conditions or to abandon transplantation due to conditional restrictions;\n11. Blood can be obtained intravenously, without other contraindications to leukapheresis;\n12. Understand and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\nExclusion criteria\n\n1. Women who are pregnant or breastfeeding, or who have a pregnancy plan within six months;\n2. Infectious diseases (such as HIV, active tuberculosis, etc.);\n3. Active hepatitis B or hepatitis C infection;\n4. Feasibility assessment screening demonstrated \\\u003C10% transfection of targeted lymphocytes or underamplification under CD3 \u002F CD28 co-stimulation (\\\u003C5-fold);\n5. Abnormal vital signs, and unable to cooperate with the examination;\n6. Have mental or mental illness who cannot cooperate with the treatment and efficacy evaluation;\n7. Highly allergic constitution or have a history of severe allergies, especially allergic to IL-2;\n8. Subjects with a systemic infection or a severe local infection requiring anti-infective treatment;\n9. Subjects with severe autoimmune disease;\n10. The doctor believes there were other reasons for inclusion.",{"count":21,"type":22},[55,56],"This is a Single-center, open, single-arm clinical study, the goal of which was to evaluate the safety and efficacy of APRIL-BAFF-Bicephali CAR-T in relapsed and refractory multiple myeloma.The study consisted of four processes: patient enrollment screening; pre-CAR T cell therapy (including leukocyte apheresis, CAR T cell preparation and chemotherapy); inpatient monitoring phase for CAR T cell transfusion; and long-term follow-up phase",[114],[282],"myeloma, Chimeric antigen receptor, April, TACI","2023-11-14",{"date":285,"type":35},"2023-11-15",{"date":287,"type":35},"2023-11-10",{"date":289,"type":22},"2027-01-01",{"name":41,"class":42},{"id":292,"slug":293,"hasResults":11,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":298,"targetDuration":4,"studyType":23,"phases":299,"briefSummary":300,"conditions":301,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":308,"leadSponsor":309,"locationsCount":43},"100525739","phase-1-administration-of-anti-tim-3cd123-car-t-cell-therapy-in-relapsed-and-refractory-acute-myeloid-leukemia-rraml-100525739","NCT06125652","Administration of Anti Tim-3\u002FCD123 CAR-T Cell Therapy in Relapsed and Refractory Acute Myeloid Leukemia (rr\u002FAML)","Application of Anti Tim-3\u002FCD123 CAR-T Cell Therapy in Relapsed and Refractory Acute Myeloid Leukemia (rr\u002FAML)","Inclusion Criteria:\n\n1. All subjects must sign and date the Informed Consent before initiating any study specific procedures or activities;\n2. At the age of 18-70 years old;\n3. Diagnosed as relapse\u002Frefractory (r\u002Fr) de novo or secondary acute myeloid leukemia (AML);\n4. The patient has recovered from the toxicity of previous treatment;\n5. ECOG score ≤ 2 and expected survival period is not less than 3 months;\n6. Adequate organ function defined as:AST ≤3×ULN; ALT ≤3×ULN; Total bilirubin ≤1.5×ULN; Serum creatinine ≤1.5×ULN, or CCR≥60 mL\u002Fmin; Hemoglobin ≥60g\u002FL ; Indoor oxygen saturation ≥92%; LVEF≥45%;\n7. Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test;\n8. From the use of study drug to 2 years after treatment, males and female of childbearing potential must agree to use an effective method of contraception.\n\nExclusion Criteria:\n\n1. Diagnosis of acute promyelocytic leukemia;\n2. History or presence of a CNS disorder;\n3. HBsAg is positive; HCV #HIV or Syphilis antibody are positive, CMV-DNA in peripheral blood is more than≥500 copies \u002FmL;\n4. History of severe hypersensitivity reaction;\n5. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, atrial fibrillation, or other clinically significant cardiac disease within 12 months before enrollment;\n6. History of organ transplant surgery;\n7. Required systemic application of immunosuppressive or other drugs;\n8. Auto-SCT within the 3 months before enrollment;\n9. Active autoimmune or inflammatory diseases of the nervous system (e.g., Guillain-Barre syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically active cerebrovascular diseases (e.g., cerebral edema, posterior reversible encephalopathy syndrome (PRES));\n10. Requirement for urgent therapy due to ongoing or impending oncologic emergency (eg, leukostasis or tumor lysis syndrome (TLS)) ;\n11. Presence or suspicion of a fungal, bacterial, viral, or other infection that is uncontrolled or requiring antimicrobials for management;\n12. Live vaccine received within the ≤ 4 weeks before enrollment;\n13. Persons with serious mental illness;\n14. History of major surgical operations four weeks before enrollment;\n15. History of alcoholism or substance abuse;\n16. Was identified by the investigators as unsuitable to participate in the study.",{"count":21,"type":22},[55,56],"To evaluate the safety and efficacy of anti Tim3\u002FCD123 CAR-T cells in the treatment of relapsed and refractory acute myeloid leukemia.",[302,303],"Acute Myeloid Leukemia Refractory","Acute Myeloid Leukemia, in Relapse","2023-11-04",{"date":306,"type":35},"2023-11-09",{"date":304,"type":35},{"date":289,"type":22},{"name":41,"class":42},""]