[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Daihong Liu\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":240},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,41,69,96,117,145,171,193,213],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100642285","phase-4-individualized-application-of-anti-thymocyte-globulinatgin-unrelated-donor-hematopoietic-stem-cell-transplantation-100642285",false,"NCT07648992","Individualized Application of Anti-Thymocyte Globulin(ATG)in Unrelated Donor Hematopoietic Stem Cell Transplantation","Application of Anti-Thymocyte Globulin(ATG) Individualized Dosing Model in Unrelated Donor Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. Patients with indications for allogeneic hematopoietic stem cell transplantation, with malignant hematologic diseases in CR1 or CR2 before transplantation.\n2. Have an HLA-matched sibling, unrelated, or haploidentical donor.\n3. Age ≥ 14 years and ≤ 65 years.\n4. Liver function: ALT and AST ≤ 2.5 × upper limit of normal, bilirubin ≤ 2 × upper limit of normal.\n5. Renal function: creatinine ≤ upper limit of normal.\n6. No uncontrolled infection or severe mental or psychological disorders.\n7. ECOG performance status score of 0-2.\n8. Signed informed consent.\n\nExclusion Criteria:\n\n\\- 1.No HLA-matched donor. 2.Malignant hematologic disease in CR3 or higher disease stage, or refractory\u002Frelapsed status.\n\n3.Patient age \\\u003C 14 years or \\> 65 years. 4.Pregnancy of either the donor or the recipient. 5.Presence of mental illness or other conditions that preclude compliance with the protocol.","ALL","14 Years","65 Years",{"count":20,"type":21},324,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This study aims to compare individualized anti-thymocyte globulin (ATG) dosing versus conventional fixed-dose regimens in unrelated donor peripheral blood stem cell transplantation (URD-PBSCT).\n\nThis study notes that URD-HSCT is a key treatment for malignant hematologic diseases and severe bone marrow failure, with rapid expansion in China. However, this study identifies post-transplant CMV infection as a major challenge, adversely affecting survival and quality of life. This study finds that CMV infection compromises immunity and causes multi-organ complications. Given the high costs, long treatment cycles, and limited efficacy of current interventions, this study considers optimizing CMV prevention to be of greater value than expanding treatment options. This study asserts that effective prevention can reduce infection rates and improve overall survival (OS) and long-term prognosis.\n\nThis study recognizes that ATG is widely used in URD-HSCT to prevent graft-versus-host disease (GVHD), but its dosage is significantly linked to CMV risk. This study indicates that inadequate ATG exposure increases GVHD risk, while excessive exposure raises viral reactivation (e.g., CMV, EBV) and may cause relapse. This study thus identifies balancing GVHD prevention and infection control as a key clinical goal. This study cites Remberger et al. (2004), who compared ATG doses (4-10 mg\u002Fkg) in 162 URD-HSCT patients, finding lower doses increased acute GVHD (aGVHD) and 10 mg\u002Fkg raised infection-related mortality, suggesting 6-8 mg\u002Fkg as a balanced range. This study also references Bacigalupo et al. (2001), who found no survival differences across doses but noted higher doses reduced severe aGVHD at the cost of increased infection. Therefore, this study concludes that optimal ATG dosing requires balancing GVHD, infection, and relapse.\n\nThis study acknowledges that ATG pharmacokinetics (PK) are complex, influenced by dose, body weight, and absolute lymphocyte count (ALC). This study points out that even with fixed dosing, internal exposure (active ATG-AUC) varies greatly among individuals, indicating that fixed dosing is suboptimal and individualized strategies are needed. This study notes that Admiraal et al. developed an ALC-based individualized ATG model, improving immune reconstitution, reducing viral infections, and enhancing OS. However, this study observes that this model was designed for non-myeloablative conditioning and is not applicable to myeloablative conditioning (MAC), which is standard in China.\n\nTo address this, this study states that our team initiated ATG PK studies in 2019. This study explains that under MAC, ALC is nearly eliminated, making traditional models unsuitable. By monitoring active ATG-AUC in 106 haploidentical HSCT (haplo-HSCT) patients and using machine learning, this study identified an optimal exposure window of 100-148.5 UE·day\u002FmL. This study found that patients within this window had lower CMV\u002FEBV reactivation without increased GVHD. This study developed a protocol adjusting doses on days -3 and -2 based on ATG concentrations measured on days -5 and -4. This study confirmed through a prospective single-arm study in haplo-HSCT that this regimen reduces CMV\u002FEBV infection and improves disease-free survival (DFS) and OS while maintaining GVHD control.\n\nGiven the consistency between URD-PBSCT and haplo-PBSCT in conditioning, GVHD prophylaxis, and CMV prevention-and that CMV infection rates in Chinese URD-PBSCT patients reach 65%-70%-this study extends the individualized ATG protocol to URD-PBSCT to validate its universality across donor sources.\n\nIn summary, building on prior haploidentical transplant research, this study applies individualized ATG dosing to URD-PBSCT. This study aims to precisely regulate ATG exposure to reduce CMV infection while maintaining GVHD prophylaxis. This study seeks to improve patient survival and outcomes, laying the foundation for a population PK model and advancing HSCT toward precision medicine.",[27],"Hematopoietic Stem Cell Transplantation","RECRUITING","2026-06-11",{"date":31,"type":32},"2026-06-15","ACTUAL",{"date":34,"type":32},"2025-12-01",{"date":36,"type":21},"2029-12-30",{"name":38,"class":39},"Daihong Liu","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":40},"100632135","phase-2-novel-therapies-for-severe-acute-gvhd-graft-versus-host-disease-100632135","NCT07509749","Novel Therapies for Severe Acute GVHD (Graft-versus-host Disease)","Prospective Randomized Controlled Trial of Novel Therapies for Severe Acute GVHD (Graft-versus-host Disease)","GVHD","Inclusion Criteria:\n\n1. diagnosed with hematological diseases.\n2. Have undergone first allogeneic hematopoietic stem cell transplantation (allo-HSCT) from any donor source using bone marrow, peripheral blood stem cells, or cord blood for hematologic malignancies.\n3. New onset of severe acute GVHD within 100 days post-transplantation.\n\nExclusion Criteria:\n\n1. Recipients of second allogeneic stem cell transplant.\n2. Acute GVHD induced by donor lymphocyte infusion, interferon.\n3. Received first line aGVHD treatment before enrollment.\n4. Overlap GVHD syndrome.\n5. Pregnant or breast-feeding women.\n6. Absolute neutrophil count (ANC) \\\u003C0.5×10e9\u002FL or platelet count (PLT) \\\u003C 20×10e9\u002FL.\n7. Serum creatinine \\> 2.0 mg\u002FdL or creatinine clearance \\\u003C 40 mL\u002Fmin measured or calculated by Cockroft-Gault equation.\n8. Uncontrolled infection.\n9. Human immunodeficiency virus infection.\n10. Active hepatitis b virus, hepatitis C virus infection and need antivirus treatment.\n11. Subjects with evidence of relapsed primary disease, or subjects who have been treated for relapse after the allo-HSCT was performed, or graft rejection.\n12. Allergic history to Janus kinase inhibitors.\n13. Severe organ dysfunction unrelated to underlying GVHD, including:\n\n(1)Cholestatic disorders or unresolved veno-occlusive disease of the liver (defined as persistent bilirubin abnormalities not attributable to GVHD and ongoing organ dysfunction).\n\n(2)Clinically significant or uncontrolled cardiac disease including unstable angina, acute myocardial infarction within 6 months from Day 1 of study drug administration, New York Heart Association Class III or IV congestive heart failure, circulatory collapse requiring vasopressor or inotropic support, or arrhythmia that requires therapy.\n\n(3)Clinically significant respiratory disease that requires mechanical ventilation support or 50% oxygen.\n\n14.Received Janus kinase inhibitor therapy after allo-HSCT for any indication. 15.Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.",{"count":50,"type":21},54,[52],"PHASE2","The purpose of this study is to determine the efficacy and safety of combined Ruxolitinib With Corticosteroids as First Line Therapy for the severe acute GVHD (graft-versus-host disease )",[55,56],"GVHD, Acute","Stem Cell Transplant Complications",[58,59,60],"acute graft-versus-host disease","Ruxolitinib","first line therapy","2026-03-29",{"date":63,"type":32},"2026-04-03",{"date":65,"type":32},"2025-06-30",{"date":67,"type":21},"2027-12-30",{"name":38,"class":39},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":40},"100630616","phase-2-enhancing-car-t-cell-therapy-efficacy-in-b-cell-lymphoma-via-chidamide-and-pd-1-inhibitor-combination-100630616","NCT07489989","Enhancing CAR-T Cell Therapy Efficacy in B-cell Lymphoma Via Chidamide and PD-1 Inhibitor Combination.","Chidamide-based Combination With PD-1 Blockade: A Synergistic Strategy to Improve CAR-T Cell Therapy Outcomes for B-cell Lymphoma.","Inclusion Criteria\n\n\\-\n\nThe patient must meet all of the following inclusion criteria:\n\n1. Histologically or cytologically confirmed CD19 and\u002For CD22-positive large B-cell lymphoma (LBCL) according to the WHO 2016 classification, including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL), and related entities, with one of the following:\n\n   1. Partial response (PR) after induction therapy with a standard first-line chemotherapy regimen (e.g., R-CHOP for 4-6 cycles); or\n   2. Complete response (CR) after standard first-line induction therapy, but with high-risk features present at initial diagnosis.\n2. Presence of high-risk features at initial diagnosis, defined as at least one of the following:\n\n   1. High-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements (\"double-hit\" or \"triple-hit\") confirmed by fluorescence in situ hybridization (FISH);\n   2. High-grade B-cell lymphoma with 11q aberration (Burkitt-like lymphoma with 11q aberration);\n   3. International Prognostic Index (IPI) score of 2-5; age-adjusted IPI (aa-IPI) score of 2-3; or National Comprehensive Cancer Network-IPI (NCCN-IPI) score of 4-8;\n   4. CD5 positivity by immunohistochemistry;\n   5. Dual expression of MYC and BCL2 by immunohistochemistry (recommended thresholds: MYC ≥ 40% and BCL2 ≥ 50%);\n   6. TP53 mutation detected by gene sequencing;\n   7. Molecular subtype MCD or N1 by next-generation sequencing (NGS);\n   8. Relapsed\u002Frefractory B-cell lymphoma, meeting one of criteria ①-④ plus criterion ⑤:\n\n      * Less than 50% tumor reduction or disease progression after ≥4 cycles of standardized chemotherapy;\n\n        * Relapse within 6 months after achieving CR with standard regimen;\n\n          * ≥2 relapses after CR;\n\n            * Relapse after hematopoietic stem cell transplantation;\n\n              * Must have received adequate prior therapy, including at least an anti-CD20 monoclonal antibody and anthracycline-containing combination chemotherapy.\n3. Age 18 to 85 years, male or female.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n5. Expected survival of \\>3 months from the date of signing informed consent.\n6. Hemoglobin (HGB) ≥60 g\u002FL (transfusion permitted).\n7. Absolute neutrophil count (ANC) ≥1,000\u002FμL and platelet count ≥45,000\u002FμL.\n8. Adequate hepatic, renal, cardiac, and pulmonary function, meeting \\*\\*all\\*\\* of the following:\n\n   1. Total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN) (except for patients with Gilbert's syndrome);\n   2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN;\n   3. Serum creatinine (Cr) ≤1.5 × ULN \\*\\*or\\*\\* creatinine clearance (CCr) ≥60 mL\u002Fmin (estimated by Cockcroft-Gault formula);\n   4. Left ventricular ejection fraction (LVEF) ≥50% by echocardiogram (ECHO), with no pericardial effusion and no clinically significant arrhythmias;\n   5. Baseline oxygen saturation by pulse oximetry \\>92% on room air;\n   6. No clinically significant pleural effusion.\n\nExclusion Criteria:\n\n* Patients eligible for CAR-T cell immunotherapy must \\*\\*NOT\\*\\* meet any of the following exclusion criteria:\n\n  1. Prior treatment with any form of chimeric antigen receptor (CAR) T-cell therapy or other genetically modified T-cell therapy.\n  2. History of severe immediate-type hypersensitivity reaction to aminoglycoside antibiotics or other drugs.\n  3. Known history of human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) infection, or any uncontrolled active systemic infection requiring intravenous antibiotics.\n\n     (Active HBV infection is defined as meeting \\*\\*all\\*\\* of the following: a) HBV DNA ≥ 2000 IU\u002FmL; b) ALT ≥ 2 × upper limit of normal (ULN); c) hepatitis not attributable to other causes such as the underlying disease or medications. Patients with active HBV at initial diagnosis who achieve non-active HBV status after adequate anti-HBV treatment may be eligible under continued effective anti-HBV therapy.)\n  4. Non-hematologic malignancy-related hepatic or renal impairment, including any of the following: ALT \\> 3 × ULN, AST \\> 3 × ULN, total bilirubin (TBIL) \\> 2 × ULN, or creatinine clearance \\\u003C 30 mL\u002Fmin.\n  5. History of myocardial infarction, percutaneous coronary intervention (including coronary angioplasty or stenting), unstable angina, active arrhythmia, or other clinically significant cardiovascular disease within the past 12 months.\n  6. Any other serious medical condition that, in the opinion of the investigator, may interfere with the study treatment or increase risk to the patient (e.g., poorly controlled diabetes, active peptic ulcer disease, severe respiratory or circulatory disease, severe autoimmune disease, congenital immunodeficiency, uncontrolled severe infection, or other conditions with high risk of clinical deterioration).\n  7. History of severe immediate-type hypersensitivity reaction to any medication required during the treatment process, or history of severe allergy to biologics (including antibiotics).\n  8. Female patients who are pregnant or breastfeeding (preconditioning chemotherapy regimen poses potential risk to the fetus or infant).\n  9. In the opinion of the investigator, the patient is unlikely to comply with all required study visits, procedures, or long-term follow-up; has poor willingness or ability to participate and cooperate fully; or has insufficient compliance (as judged by the patient and\u002For family).\n  10. History of other malignancy, unless the patient has been disease-free and has received no antitumor therapy for at least 3 years (exceptions: non-melanoma skin cancer, and carcinoma in situ of the cervix, bladder, or breast).\n  11. Receipt of a live vaccine within 6 weeks prior to initiation of the preconditioning regimen.\n  12. Major surgery (excluding lymph node biopsy) within the past 14 days, or anticipated need for major surgery during the treatment period.\n  13. Any other serious physical or psychiatric illness, or clinically significant laboratory abnormality, that may increase the risk associated with study participation, interfere with the interpretation of study results, or render the patient unsuitable for participation in the opinion of the investigator.","18 Years","85 Years",{"count":79,"type":21},30,[52],"B-cell non-Hodgkin lymphoma (B-NHL) is one of the most common malignancies in China, with approximately 100,000 new cases diagnosed annually. Although immunochemotherapy, novel small-molecule targeted agents, and hematopoietic stem cell transplantation have significantly improved outcomes for patients with B-cell malignancies, nearly half of patients still experience drug resistance and relapse. In high-risk aggressive B-cell lymphoma, the 5-year survival rate remains around 50%. Previous clinical guidelines recommended autologous hematopoietic stem cell transplantation as first-line consolidation therapy for high-risk patients; however, multiple studies have demonstrated that even after autologous transplantation, nearly half of these patients relapse and succumb to the disease.\n\nChimeric antigen receptor T (CAR-T) cell therapy has achieved objective response rates of approximately 50% in relapsed\u002Frefractory lymphoma, particularly in B-cell subtypes. Nevertheless, limitations such as tumor immune antigen escape, immunosuppressive effects of the tumor microenvironment (TME) on CAR-T cells, and T-cell exhaustion continue to restrict the durability and efficacy of CAR-T-mediated cytotoxicity.\n\nThis study evaluates the incorporation of chidamide (an HDAC inhibitor) combined with a PD-1 inhibitor as maintenance therapy following CAR-T cell immunotherapy in patients with relapsed\u002Frefractory high-risk aggressive B-cell lymphoma. By implementing an \"early intervention\" strategy-prompt administration of CAR-T cell therapy after induction treatment for relapsed\u002Frefractory high-risk aggressive B-cell lymphoma-and subsequent maintenance with chidamide plus a PD-1 inhibitor, the approach aims to reduce relapse rates and improve overall survival. These strategies are intended to address the current unmet clinical need for improved outcomes in relapsed\u002Frefractory high-risk aggressive B-cell lymphoma, where prognosis remains poor despite existing therapies.",[83],"Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R\u002FR DLBCL)",[83,85,86,87],"CAR-T therapy","Chidamide","PD-1 inhibitor","2026-03-18",{"date":90,"type":32},"2026-03-24",{"date":92,"type":32},"2025-05-15",{"date":94,"type":21},"2027-05-15",{"name":38,"class":39},{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":111,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":40},"100630581","phase-2-study-of-pd-1ab21-bcma-car-t-therapy-for-consolidation-of-multiple-myelomawith-renal-dysfunction-100630581","NCT07489534","Study of PD-1Ab21-BCMA CAR-T Therapy for Consolidation of Multiple Myelomawith Renal Dysfunction","Exploratory Clinical Study on PD-1Ab21-BCMA CAR-T Cells (CD203) for First-line Consolidation Therapy of Multiple Myeloma With Renal Dysfunction","Inclusion Criteria:\n\n1. Age: Over 14 years old\n2. Diagnosed with multiple myeloma accompanied by renal dysfunction, received ≥ 2 courses of clinical first-line treatment, evaluated efficacy above PR, and predicted survival of more than three months.\n3. The hospital examination meets the following indicators:\n\n   1. ECOG physical status score 0-2 or KPS score\\>80 points\n   2. Having sufficient venous access for single or intravenous blood collection, and no other blood cells Separation contraindications\n   3. WBC≥1×109\u002FL，LY≥0.3×109\u002FL，\n   4. ALT and AST ≤ 2.5 ULN\n   5. Serum total bilirubin ≤ 2.0mg\u002FdL (34.2 μmol\u002FL)\n   6. PT:INR\\\u003C1.7 or PT prolonged by\\\u003C4s compared to normal value\n\nExclusion Criteria:\n\n1. Pregnant or lactating women (the safety of this treatment for unborn babies is unknown, and the assessment of pregnancy status for female participants is negative in serum or urine pregnancy tests within 48 hours prior to infusion);\n2. Any uncontrollable active infection;\n3. Presence of active hepatitis B or C virus infection;\n4. HIV\u002FAIDS infection;\n5. Has neurological disorders;\n6. Within 2 weeks prior to signing the informed consent form, systemic use of steroid drugs (inhalable steroids may be used);\n7. Allergies to immunotherapy and related drugs;\n8. Currently, there are patients with heart disease or poorly controlled hypertension who require treatment;\n9. Currently, patients with unstable or active ulcers or gastrointestinal bleeding;\n10. Patients with a history of organ transplantation or waiting for organ transplantation;\n11. Hyponatremia, blood sodium\\\u003C125mmol\u002FL;\n12. Baseline blood potassium\\\u003C3.5mmol\u002FL (potassium can be supplemented before participating in the study to restore blood potassium levels above this level);\n13. The patient needs anticoagulant therapy (such as warfarin or heparin);\n14. The patient requires long-term antiplatelet therapy (aspirin, dose\\>300mg\u002Fd); Clopidogrel, dose\\>75mg\u002Fd).\n\nAdditionally,\n\n1. Patients currently participating in other clinical trials;\n2. Researchers believe that other reasons are not suitable for clinical trial participants.",{"count":104,"type":21},25,[52],"The purpose of this study is to determine the efficacy and safety of targeted BCMA CART cells secreting PD1 and interleukin 21 fusion protein immunotherapy for first-line consolidation therapy of multiple myeloma with renal dysfunction.",[108],"Multiple Myeloma",[110],"multiple myeloma; renal dysfunction; CART; fusion protein; consolidation therapy",{"date":90,"type":32},{"date":113,"type":32},"2025-09-29",{"date":115,"type":21},"2027-07-31",{"name":38,"class":39},{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":76,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":22,"phases":127,"briefSummary":129,"conditions":130,"keywords":133,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":40},"100626625","phase-1-ebv-ast-cell-therapy-for-ebv-related-diseases-after-stem-cell-transplantation-100626625","NCT07438067","EBV-AST Cell Therapy for EBV-Related Diseases After Stem Cell Transplantation","A Prospective Exploratory Study of EBV-AST Cell Injection for the Treatment of EBV-Related Diseases After Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. The patient must be aged 18-75 years.\n2. ust have undergone Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT).\n3. Must have EBV-DNA viremia post-transplant, with EBV-DNA \\> 1000 copies\u002FmL (on two consecutive tests or one test \\> 10,000 copies\u002FmL).\n4. Karnofsky Performance Score (KPS) of 70 or higher.\n5. Expected survival of at least 3 months.\n6. Sufficient organ function, including renal (serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL\u002Fmin), hepatic (AST, ALT, and total bilirubin ≤ 5 × ULN), and hematologic parameters (platelets ≥ 10 × 10\\^9\u002FL, neutrophils ≥ 1.0 × 10\\^9\u002FL).\n7. HLA-matching criteria must be met for the donor\u002Frecipient.\n\nExclusion Criteria:\n\n1. Active GVHD (Grade 2 or higher) or requiring \\>0.5 mg\u002Fkg\u002Fday corticosteroids for GVHD.\n2. History of CMV viremia or disease within the past week.\n3. PTLD (Post-Transplant Lymphoproliferative Disorder) diagnosed or suspected within 1 week before infusion.\n4. Severe active infections (excluding EBV and CMV).\n5. Serious allergic reactions or contraindications to the infusion.\n6. Previous immune therapy-related adverse events of Grade 3 or higher.\n7. History of HIV, HCV, or HBV infection with an active viral load.","75 Years",{"count":126,"type":21},18,[128,52],"PHASE1","This exploratory clinical study focuses on the use of EBV-AST cell infusion for treating EBV-DNA viremia following allogeneic hematopoietic stem cell transplantation (Allo-HSCT). The study aims to determine the maximum tolerated dose (MTD) or optimal biological dose (OBD) of EBV-AST cells and assess their safety, tolerability, and preliminary efficacy in treating EBV-DNA viremia. The study will involve a 3+3 dose escalation design to evaluate three different dosages of EBV-AST cell infusion. The study is expected to provide important insights into the clinical application of cell-based therapies for EBV infections.",[131,132],"EBV-DNA Viremia","Post-Transplant Lymphoproliferative Disorder",[134,135,136],"EBV-DNA viremia","Allogeneic Hematopoietic Stem Cell Transplantation","EBV-AST cell infusion","2026-02-26",{"date":139,"type":32},"2026-02-27",{"date":141,"type":32},"2025-03-26",{"date":143,"type":21},"2028-03-26",{"name":38,"class":39},{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":16,"minAge":76,"maxAge":152,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":154,"briefSummary":155,"conditions":156,"keywords":159,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":40},"100627573","phase-1-ebv-ast-cell-injection-for-ebv-associated-lymphoproliferative-disorders-100627573","NCT07450391","EBV-AST Cell Injection for EBV-Associated Lymphoproliferative Disorders","Exploratory Clinical Study of EBV-AST Cell Injection for the Treatment of EBV-Associated Lymphoproliferative Disorders","Inclusion Criteria:\n\n1. Able to understand and voluntarily sign written informed consent.\n2. Age 18 to 75 years, inclusive.\n3. HLA genotype matches at least one of the following: HLA-A02:01, HLA-A11:01, or HLA-A\\*24:02.\n4. Karnofsky Performance Status (KPS) ≥ 70.\n5. Life expectancy ≥ 3 months.\n6. Diagnosed with EBV-associated lymphoproliferative disorders, including:\n7. EBV infection-associated post-transplant lymphoproliferative disorder (PTLD) that is relapsed\u002Frefractory after at least first-line standard therapy; or\n8. EBV-associated lymphoma confirmed by histology and\u002For cytology with EBER positivity (ISH\u002FFISH), with no standard treatment available or not suitable for standard therapy, including but not limited to: EBV-positive DLBCL, EBV-positive NK\u002FT-cell lymphoma, EBV-positive Hodgkin lymphoma, EBV-positive Burkitt lymphoma, EBV-positive nodal TFH lymphoma (AITL type), and EBV-positive primary cutaneous T-cell lymphoma, meeting protocol-defined relapsed\u002Frefractory criteria.\n9. Absolute lymphocyte count ≥ 0.8 × 10\\^9\u002FL (except for PTLD participants).\n10. Adequate organ and bone marrow function per protocol-defined criteria.\n11. Participants of childbearing potential agree to use highly effective contraception throughout the study; women of childbearing potential must have a negative pregnancy test at screening.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to the investigational product or its components.\n2. Uncontrolled active graft-versus-host disease (GVHD) in PTLD participants.\n3. Known primary immunodeficiency disorders (e.g., X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, chronic granulomatous disease, hyper-IgE syndrome).\n4. Severe uncontrolled medical conditions that, in the investigator's judgment, make the participant unsuitable for enrollment.\n5. Serious cardiac disease within 6 months prior to first infusion (e.g., myocardial infarction, severe\u002Funstable angina, bypass surgery, NYHA class III-IV heart failure).\n6. Chronic diseases requiring systemic immunosuppressants or systemic steroids (except local\u002Finhaled steroids or physiologic replacement therapy).\n7. History of other malignancy within the past 5 years, except carcinoma in situ (e.g., cervix, bladder, breast) or non-melanoma skin cancer.\n8. Receipt of lymphocyte-based immunotherapy (e.g., CIK, DC, DC-CIK, LAK) within 3 months prior to consent.\n9. Receipt of interferon or other targeted immunodeficiency drugs within 3 months prior to consent; prior high-dose IL-2 therapy.\n10. Anti-cancer therapy within 14 days prior to consent (including chemotherapy or immunosuppressants\u002Fsteroids); other cell therapy or live vaccines\u002Fattenuated vaccines or other investigational drugs within 28 days prior to consent; curative radiotherapy or major surgery within 4 weeks, or palliative local radiotherapy within 2 weeks prior to consent.\n11. Prior immune therapy-associated ≥ Grade 3 immune-related adverse events (irAEs).\n12. Unresolved toxicity from prior therapy \\> Grade 1 (except alopecia any grade; peripheral sensory neuropathy ≤ Grade 2).\n13. Uncontrolled psychiatric or neurologic disorders; drug abuse or alcohol dependence.\n14. Positive HIV antibody; positive Treponema pallidum antibody; active hepatitis B (HBsAg and\u002For HBeAg positive with HBV-DNA above ULN) or active hepatitis C (HCV-Ab positive and HCV-RNA positive).\n15. Uncontrolled severe active infection or contagious disease (excluding EBV infection).\n16. Pregnant or breastfeeding women.","70 Years",{"count":126,"type":21},[128,52],"This is an investigator-initiated, open-label, single-arm, dose-escalation exploratory study to evaluate the safety, tolerability, and preliminary efficacy of EBV-AST cell injection in adults with EBV-associated lymphoproliferative disorders, including post-transplant lymphoproliferative disease (PTLD) and EBV-positive lymphomas. Participants will receive EBV-AST cell infusions intravenously every 2 weeks for up to 3 infusions at escalating dose levels. The primary objective is to assess safety and determine a potential optimal biologically active dose. Secondary objectives include preliminary tumor response and EBV-related virologic outcomes, as well as cellular PK\u002FPD.",[157,158],"Epstein-Barr Virus-Associated Lymphoproliferative Disorders","EBV-Positive Lymphoma",[160,161,162,163],"EBV-associated lymphoproliferative disorder","EBV-positive lymphoma","Adoptive T-cell therapy","Antigen-specific T cells",{"date":165,"type":32},"2026-03-04",{"date":167,"type":32},"2025-06-01",{"date":169,"type":21},"2027-06-01",{"name":38,"class":39},{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":16,"minAge":76,"maxAge":152,"enrollmentInfo":178,"targetDuration":4,"studyType":22,"phases":179,"briefSummary":180,"conditions":181,"keywords":183,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":191,"leadSponsor":192,"locationsCount":40},"100621285","phase-1-exploratory-study-of-ebv-tcr-t-cell-injection-for-ebv-dnaemia-after-allogeneic-hematopoietic-stem-cell-transplantation-100621285","NCT07368634","Exploratory Study of EBV-TCR-T Cell Injection for EBV DNAemia After Allogeneic Hematopoietic Stem Cell Transplantation","An Exploratory Clinical Study of EBV-TCR-T Cell Injection for the Treatment of EBV DNAemia After Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* Age ≥ 18 years at the time of enrollment.\n* History of allogeneic hematopoietic stem cell transplantation.\n* Presence of Epstein-Barr virus (EBV) DNAemia confirmed by quantitative polymerase chain reaction (qPCR) in peripheral blood.\n* EBV DNAemia persisting or increasing despite standard management, as determined by the investigator.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Adequate organ function as defined by the study protocol.\n* Ability to understand and willingness to sign written informed consent.\n\nExclusion Criteria:\n\n* Diagnosis of EBV-associated lymphoproliferative disorder requiring immediate cytotoxic chemotherapy.\n* Active, uncontrolled infection other than EBV.\n* History of severe autoimmune disease requiring systemic immunosuppressive therapy.\n* Uncontrolled graft-versus-host disease requiring high-dose systemic corticosteroids or other immunosuppressive treatment.\n* Prior treatment with EBV-specific adoptive T cell therapy within a defined washout period.\n* Known active malignancy other than EBV-related disease that may interfere with study participation.\n* Pregnant or breastfeeding women.\n* Any medical, psychological, or social condition that, in the opinion of the investigator, would interfere with safe participation in the study.",{"count":126,"type":21},[128,52],"Epstein-Barr virus (EBV) DNAemia is a common and potentially serious complication after allogeneic hematopoietic stem cell transplantation (allo-HSCT) and may progress to EBV-associated lymphoproliferative disorders. Current treatment options are limited, and effective immune-based therapies are still needed.\n\nThis is an investigator-initiated, exploratory, open-label, single-arm clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of EBV-specific T cell receptor-engineered T cells (EBV-TCR-T cell injection) in patients with EBV DNAemia after allo-HSCT. Eligible participants will receive intravenous infusions of EBV-TCR-T cells at escalating dose levels. Safety outcomes, EBV-DNA clearance, and preliminary efficacy will be assessed, along with pharmacokinetic and pharmacodynamic characteristics of the infused cells.",[182,132],"Epstein-Barr Virus Infection",[184,185,186],"EBV DNAemia","TCR-T Cell Therapy","Dose Escalation Study","2026-01-26",{"date":189,"type":32},"2026-01-28",{"date":167,"type":32},{"date":169,"type":21},{"name":38,"class":39},{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":47,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":22,"phases":202,"briefSummary":203,"conditions":204,"keywords":206,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":211,"leadSponsor":212,"locationsCount":40},"100619138","phase-2-novel-first-line-therapies-for-grade-ii-acute-gvhdgraft-versus-host-disease--100619138","NCT07340723","Novel First-line Therapies for Grade II Acute GVHD(Graft-versus-host Disease )","Novel First-line Therapies for Grade II Acute GVHD: a Randomized Controlled Trial","Inclusion Criteria:\n\n1. Diagnosed with hematological diseases.\n2. Have undergone first allogeneic hematopoietic stem cell transplantation (allo-HSCT) from any donor source using bone marrow, peripheral blood stem cells, or cord blood for hematologic malignancies.\n3. New onset of grade II acute GVHD or intermediate or high risk aGVHD (based on modified GVHD Glucksberg criteria) within 100 days post-transplantation.\n\nExclusion Criteria:\n\n1. Recipients of second allogeneic stem cell transplant.\n2. Acute GVHD induced by donor lymphocyte infusion, interferon.\n3. Received first line aGVHD treatment before enrollment.\n4. Overlap GVHD syndrome.\n5. Pregnant or breast-feeding women.\n6. Pregnant or breast-feeding women.\n7. Serum creatinine \\> 2.0 mg\u002FdL or creatinine clearance \\\u003C 40 mL\u002Fmin measured or calculated by Cockroft-Gault equation.\n8. Uncontrolled infection.\n9. Human immunodeficiency virus infection.\n10. Active hepatitis b virus, hepatitis C virus infection and need antivirus treatment.\n11. Subjects with evidence of relapsed primary disease, or subjects who have been treated for relapse after the allo-HSCT was performed, or graft rejection.\n12. Allergic history to Janus kinase inhibitors.\n13. Severe organ dysfunction unrelated to underlying GVHD, including:\n\n(1)Cholestatic disorders or unresolved veno-occlusive disease of the liver (defined as persistent bilirubin abnormalities not attributable to GVHD and ongoing organ dysfunction).\n\n(2)Clinically significant or uncontrolled cardiac disease including unstable angina, acute myocardial infarction within 6 months from Day 1 of study drug administration, New York Heart Association Class III or IV congestive heart failure, circulatory collapse requiring vasopressor or inotropic support, or arrhythmia that requires therapy.\n\n(3)Clinically significant respiratory disease that requires mechanical ventilation support or 50% oxygen.\n\n14.Received Janus kinase inhibitor therapy after allo-HSCT for any indication. 15.Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.",{"count":201,"type":21},168,[52],"The purpose of this study is to determine the efficacy and safety of combined Ruxolitinib With Corticosteroids as First Line Therapy for grade II acute GVHD (graft-versus-host disease )",[205,56],"GVHD,Acute",[58,59,60],"2026-01-05",{"date":209,"type":32},"2026-01-14",{"date":167,"type":32},{"date":169,"type":21},{"name":38,"class":39},{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":77,"enrollmentInfo":220,"targetDuration":4,"studyType":22,"phases":222,"briefSummary":223,"conditions":224,"keywords":226,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":40},"100617644","phase-2-polymer-lipid-particle-delivered-car1920-mrna-car-t-therapy-for-relapsedrefractory-b-cell-lymphomaleukemia-100617644","NCT07321301","Polymer-lipid Particle-delivered CAR1920 mRNA CAR-T Therapy for Relapsed\u002FRefractory B-cell Lymphoma\u002FLeukemia","An Exploratory Clinical Study of CAR-T Cell Immunotherapy Using Polymer-lipid Particles to Deliver CAR1920 mRNA Targeting CD19\u002FCD20 for Thetreatment of Relapsed\u002FRefractory B-cell Lymphoma\u002FLeukemia","Inclusion Criteria:\n\n1. Has voluntarily given informed consent, signed the informed consent form, and is willing and able to comply with the scheduled visits, study treatment, laboratory tests, imaging examinations, and other necessary trial procedures as required in the protocol;\n2. Patients with relapsed\u002Frefractory (R\u002FR) B-cell lymphoma\u002Fleukemia confirmed by histopathology, cytogenetics, molecular biology, clinical judgment, medical history, and other assessment methods in accordance with the WHO 2016 classification criteria, who have experienced disease progression under standard treatment regimens, are intolerant to standard treatment regimens, or lack effective standard treatment options;\n3. Must meet the following criteria for R\u002FR B-cell malignant tumors:\n\n(1) B-cell tumors include 3 categories:\n\n* B-cell acute lymphoblastic leukemia (B-ALL);\n\n  ② Indolent B-cell lymphomas, including chronic lymphocytic leukemia (CLL), follicular lymphoma (FL), marginal zone lymphoma (MZL), lymphoplasmacytic lymphoma (LPL), hairy cell leukemia (HCL), etc.;\n\n  ③ Aggressive B-cell lymphomas, including diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), mantle cell lymphoma (MCL); (2) R\u002FR B-ALL (meeting any 1 of the 4 criteria below):\n* Relapse within 6 months after the first complete response (CR);\n\n  * Primary refractory patients who failed to achieve CR after 2 cycles of standard chemotherapy;\n\n    * Failure to achieve CR or relapse after first-line or multi-line salvage chemotherapy; ④ Relapse after hematopoietic stem cell transplantation (HSCT); (3) R\u002FR B-cell lymphoma (meeting any 1 of the first 4 criteria below plus criterion 5):\n* Tumor reduction \\\u003C 50% or disease progression after 4 courses of standardized chemotherapy per standard regimens;\n\n  * Relapse within 6 months after achieving CR with standard chemotherapy;\n\n    * ≥ 2 relapses after CR;\n\n      * Relapse after HSCT; ⑤ Adequate prior treatment received, including at least anti-CD20 monoclonal antibody and anthracycline-containing combination chemotherapy regimens; 4. Aged 18-85 years (inclusive), male or female; 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 6. Expected survival \\> 14 days from the date of signing the informed consent form; 7. Hemoglobin (HGB) ≥ 60 g\u002FL (transfusion allowed); 8. Absolute neutrophil count (ANC) ≥ 1,000\u002Fμl and platelet count ≥ 45,000\u002Fμl in peripheral blood (transfusion allowed); 9. Hepatic, renal, cardiac, and pulmonary functions meeting the following requirements:\n\n        1. Total Bilirubin (TBIL) ≤ 1.5 × Upper Limits of Normal (ULN), excluding subjects with Gilbert's syndrome;\n        2. Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 × ULN;\n        3. Serum Creatinine (Cr) ≤ 1.5 × ULN or Creatinine Clearance Rate (CCr) ≥ 60 mL\u002Fmin (CCr estimated by the Cockcroft-Gault formula);\n        4. Left Ventricular Ejection Fraction (LVEF) ≥ 50%; echocardiogram (ECHO) confirms no clinically significant severe pericardial effusion or severe arrhythmia;\n        5. Baseline transcutaneous oxygen saturation \\> 90% under room air;\n        6. No clinically significant severe pleural effusion; 10. Subjects with pregnancy plans must agree to use contraceptive measures from before study enrollment until 6 months after the end of the study;\n\nExclusion Criteria:\n\n1. Previous receipt of any form of chimeric antigen receptor (CAR) cell therapy or other genetically modified T-cell therapies;\n2. History of severe immediate-type hypersensitivity reactions to commonly used drugs such as aminoglycoside antibiotics;\n3. Known history of Human Immunodeficiency Virus (HIV) infection, active Hepatitis B Virus (HBV) infection, or any uncontrolled active systemic infection requiring intravenous antibiotics (active HBV infection is defined as meeting all three of the following criteria: a. HBV DNA quantitation ≥ 2000 IU\u002Fml; b. ALT ≥ 2 × Upper Limits of Normal (ULN); c. Exclusion of hepatitis caused by other factors such as the disease itself or medications. If a patient was diagnosed with active HBV infection initially and converted to inactive HBV infection after anti-HBV treatment, they may be included in this study with adequate ongoing anti-HBV treatment);\n4. Hepatic or renal impairment unrelated to hematologic malignancies (e.g., lymphoma): ALT \\> 3 × ULN, AST \\> 3 × ULN, TBIL \\> 2 × ULN, or serum creatinine clearance \\\u003C 30 mL\u002Fmin;\n5. History of myocardial infarction, cardiac angioplasty, coronary artery stenting, unstable angina pectoris, active arrhythmia, or other clinically significant cardiovascular diseases within 12 months prior to enrollment;\n6. Other severe medical conditions that may affect the study (e.g., poorly controlled diabetes mellitus, gastric ulcer, other severe cardiorespiratory diseases, concurrent severe autoimmune diseases or congenital immunodeficiencies, uncontrolled severe infections, etc.), as well as other diseases with a high risk of condition deterioration; patients who received allogeneic hematopoietic stem cell transplantation (allo-HSCT) and still have acute graft-versus-host disease (GVHD) 1 month after discontinuing immunosuppressants. The decision is at the investigator's discretion;\n7. History of severe immediate-type hypersensitivity reactions to any specific drugs required in this study; or history of severe hypersensitivity to biological products (including antibiotics);\n8. Female subjects who are pregnant or lactating (due to potential risks of treatment to the fetus or infant);\n9. Subjects judged by the investigator to be unable to complete all scheduled visits, investigations, or diagnostic and therapeutic procedures required by the study protocol (including medium- and long-term follow-up visits), those with poor willingness to participate, those who are unwilling to join or fully cooperate with the study arrangements, or those with insufficient compliance of the subject and their family members. The decision is at the investigator's discretion;\n10. Concurrent progressive malignant tumors of other types; or a history of other malignant tumors, except for non-melanoma skin cancers and carcinoma in situ (e.g., of the cervix, bladder, or breast). Subjects with a history of other malignant tumors are ineligible unless they have been disease-free and not received any form of anti-tumor treatment for at least 3 consecutive years;\n11. History of live vaccine vaccination within 6 weeks prior to the start of the conditioning regimen;\n12. Receipt of major surgical procedures (excluding lymph node biopsy) within the past 14 days, or anticipated need for major surgery during the treatment period;\n13. Other severe physical or mental illnesses or laboratory abnormalities that may increase the risk of study participation or interfere with study results, as well as patients deemed unsuitable for participation by the investigator.",{"count":221,"type":21},10,[52],"The purpose of this study is to determine the efficacy and safety of the CAR-T cell immunotherapy utilizing polymer-lipid nanoparticles for delivering CD19\u002FCD20 dual-targeting InViVoCAR1920 mRNA, for the first-line consolidation therapy of relapsed\u002Frefractory B-cell lymphoma\u002Fleukemia.",[225],"B-cell Lymphoma Refractory",[227,225,228,229,230,231],"consolidation therapy","CAR-T","Lipid Nanoparticles","RNA Transport","Patient Safety","2025-12-22",{"date":234,"type":32},"2026-01-07",{"date":236,"type":32},"2025-09-01",{"date":238,"type":21},"2027-08-31",{"name":38,"class":39},""]