[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hrain Biotechnology Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":140},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,66,91,117],{"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":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100642612","phase-1-to-evaluate-the-safety-and-tolerability-of-anti-human-cd70-t-cell-injection-in-subjects-with-advancedmetastatic-renal-cancer-100642612",false,"NCT07647744","To Evaluate the Safety and Tolerability of Anti-Human CD70 T-Cell Injection in Subjects With Advanced\u002FMetastatic Renal Cancer","A Phase I Clinical Study to Evaluate the Safety and Tolerability of Anti-Human CD70 T-Cell Injection in Subjects With Advanced\u002FMetastatic Renal Cell Carcinoma","Inclusion Criteria:\n\n1. Age 18 to 70 years (inclusive), regardless of gender;\n2. Life expectancy of more than 12 weeks;\n3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 1;\n4. Subjects with advanced\u002Fmetastatic renal cell carcinoma (RCC):\n\n   1. Histologically confirmed clear cell renal cell carcinoma (ccRCC), with an International Metastatic RCC Database Consortium (IMDC) risk stratification of intermediate or high risk as evaluated by the investigator;\n   2. Has at least one measurable lesion according to RECIST 1.1;\n   3. Tumor tissue samples must test positive for CD70 expression via immunohistochemistry (IHC);\n   4. Must have received at least one prior line of systemic therapy (must include at least: (1) immuno-oncology (IO) combination therapy: concomitant targeting of PD-1 and CTLA-4, or (2) an immune checkpoint inhibitor (PD-1\u002FPD-L1 inhibitor) combined with a VEGF\u002FVEGFR-targeted agent);\n5. Venous access required for apheresis can be established; hemoglobin ≥ 90 g\u002FL, absolute neutrophil count (ANC) ≥ 1.5×10\\^9\u002FL, and platelet count ≥ 100× 10\\^9\u002FL, and the leukepheresis can be carried according to the judgement of investigators;\n6. Hepatic, renal, cardiac, and pulmonary functions must meet the following criteria:\n\n   1. Creatinine clearance (CrCl) ≥ 50 mL\u002Fmin (calculated by the Cockcroft-Gault formula);\n   2. Left ventricular ejection fraction (LVEF) \\> 50%;\n   3. Baseline peripheral oxygen saturation \\> 95%;\n   4. Total bilirubin ≤2 × upper limit of normal (ULN);\n   5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN;\n7. Voluntary participation in the clinical study: Must understand and be informed about this study, voluntarily sign the Informed Consent Form (ICF), and be willing to complete all study procedures.\n\nExclusion Criteria:\n\n1. Prior treatment with anti-CD70 targeted therapies;\n2. Brain metastasis from renal cell carcinoma;\n3. Concomitant with other uncontrolled malignancies, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, or thyroid cancer after radical surgery;\n4. Any uncontrolled active infection, including but not limited to active tuberculosis; presence or suspicion of an uncontrolled infection, or an infection requiring systemic intravenous therapy within 14 days prior to enrollment (including fungal, bacterial, viral, or other infections);\n5. Subjects who are hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody (HBcAb) positive, with peripheral blood HBV DNA titers above the lower limit of detection (LLOD) of the study site; those who are hepatitis C virus (HCV) antibody positive with peripheral blood HCV RNA positive; those who are human immunodeficiency virus (HIV) antibody positive; or those who test positive for syphilis;\n6. Any unstable systemic disease, including but not limited to: unstable angina, cerebrovascular accident or transient ischemic attack within 6 months prior to screening, myocardial infarction within 6 months prior to screening, congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥ III ), poorly controlled diabetes mellitus (glycated hemoglobin HbA1c \\> 8% at screening), poorly controlled severe arrhythmia, and hepatic, renal, or metabolic diseases by medication;\n7. Pregnant or lactating woman, and female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner plans to have a pregnancy within 1 year after cell transfusion (except for subjects of childbearing potential who are willing to use highly effective and reliable methods of contraception uninterruptedly for 1 year after the study treatment);\n8. Prior treatment with CAR-T therapy or other genetically modified cell therapies prior to screening;\n9. History of implantation of a cardiac pacemaker or deep brain stimulator;\n10. Vaccination with live attenuated vaccines within 4 weeks prior to leukapheresis;\n11. History of autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) within the past 2 years that resulted in end-organ damage, or required systemic immunosuppressive therapy or other systemic disease-controlling medications;\n12. History of central nervous system (CNS) diseases, such as seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, or psychiatric disorders; or known active CNS involvement or history thereof;\n13. Subjects who are receiving systemic steroid therapy prior to screening, and who are judged by the investigator to require long-term use of systemic steroids during the study treatment period (excluding inhaled or topical steroids);\n14. Presence of medical conditions that interfere with the ability to sign the written Informed Consent Form (ICF) or comply with study procedures; or those who are unwilling or unable to comply with study requirements;\n15. History of severe immediate hypersensitivity reactions to any of the medications to be used in this study;\n16. Any other conditions that, in the opinion of the investigator, make the subject unsuitable for participation in this study.","ALL","18 Years","70 Years",{"count":20,"type":21},18,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a single-arm, open-label, dose-escalating Phase 1 clinical study. It aims to evaluate the safety, tolerability and pharmacokinetic(PK) profiles of the investigational agent, and preliminarily assess its efficacy in subjects with advanced\u002Fmetastatic renal cell carcinoma, and determine the recommended dose and infusion regimen for Phase 2 trials.",[27],"Renal Cell Carcinoma (RCC)",[29,30,31],"Renal cell carcinoma","Chimeric antigen receptor","CD70","RECRUITING","2026-06-30",{"date":35,"type":36},"2026-07-02","ACTUAL",{"date":33,"type":36},{"date":39,"type":21},"2034-06",{"name":41,"class":42},"Hrain Biotechnology Co., Ltd.","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":43},"100574513","early-phase-1-evaluation-of-the-safety-and-efficacy-of-human-ci-135-flt3-targeted-car-t-cells-injection-for-subjects-with-relapsedrefractory-acute-myeloid-leukemia-100574513","NCT06760260","Evaluation of the Safety and Efficacy of Human CI-135 (FLT3) Targeted CAR-T Cells Injection for Subjects with Relapsed\u002FRefractory Acute Myeloid Leukemia","A Study to Evaluate the Safety and Efficacy of CI-135 CAR-T Cell Injection in the Treatment of Relapsed\u002FRefractory Acute Myeloid Leukemia","Inclusion Criteria:\n\nSubjects must meet all of the following criteria to be enrolled:\n\n* Subjects volunteer to participate in clinical trails, understand and inform the trials and sign informed consent form, be willing to complete all the trial procedures;\n* Aged from 18 to 70 years (including cut-off value), Male and female;\n* Expected survival \\> 12 weeks;\n* Previously diagnosed as Acute Myeloid Leukemia by ELN updated criteria (2017) and one of the following indicators that is satisfied:\n\n  1. AML patients who have not achieved complete remission (CR) after at least three cycles of standard induction therapy, or\n  2. AML patients who achieved complete remission after induction therapy but relapsed within one year, or\n  3. AML patients who achieved complete remission after induction therapy for more than one year but did not achieve remission after one cycle of chemotherapy with the original regimen following relapse, or\n  4. AML patients who relapsed after transplantation, or\n  5. AML patients who experienced two or more relapses. Note: For patients meeting conditions a), b), or c) with FLT3 mutations, they must have undergone at least one treatment with a tyrosine kinase inhibitor (TKI) without achieving complete remission or have relapsed after achieving complete remission, except for those who cannot tolerate TKI therapy or have contraindications to TKI treatment.\n* Positive for FLT3 mutation confirmed by leukemia cell genetic testing, or FLT3 expression ≥35%;\n* ECOG performance status score of 1-2;\n* Liver, kidney, heart, and lung functions meeting the following criteria:\n\n  1. Glomerular filtration rate (GFR) ≥60 ml\u002Fmin\u002F1.73 m² or serum creatinine ≤2 times the upper limit of normal (ULN);\n  2. Serum AST and ALT ≤3 times of ULN, and total bilirubin ≤1.5 times the ULN;\n  3. Oxygen saturation \\> 92%;\n  4. Left ventricular ejection fraction (LVEF) ≥50%, with no pericardial effusion observed on ultrasound, and no clinically significant electrocardiographic abnormalities.\n* Able to understand the study and sign the informed consent form.\n\nExclusion Criteria:\n\n* Diagnosed as acute promyelocytic leukemia (APL M3);\n* With any presence of other uncontrolled malignancies (unless evaluated as unlikely to interfere with the safety or efficacy assessment of the trial);\n* Previously treated with CAR-T cells or other genetically modified cellular therapies\n* Displayed history or evidence of significant cardiovascular risks, including any of the following: congestive heart failure, unstable angina, clinically significant arrhythmias (e.g., ventricular fibrillation, ventricular tachycardia), coronary angioplasty within 6 months before administration, implantable cardiac defibrillator, or any clinically relevant comorbidities that pose safety risks or interfere with study assessments, procedures, or completion;\n* Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with HBV DNA levels ≥ the detection limit in peripheral blood; positive for hepatitis C virus (HCV) antibody with detectable HCV RNA; positive for human immunodeficiency virus (HIV) antibodies; or positive for syphilis testing;\n* Positive for acute or chronic hepatitis C. Exceptions: acute hepatitis C with complete viral clearance; chronic hepatitis C with a sustained virological response (SVR24) 24 weeks post-treatment confirming undetectable viral load;\n* Having history of arterial or venous thrombosis within 3 months prior to enrollment;\n* Having history of Graft-versus-host disease requiring systemic immunomodulators;\n* Having history of central nervous system diseases or conditions requiring treatment (e.g., uncontrolled seizures);\n* Having uncontrolled active infections;\n* Known allergy to any components of CI-135 CAR-T cell formulation or the lymphodepletion regimen (cyclophosphamide and fludarabine);\n* Currently pregnant or lactating female, or female subjects planning pregnancy within 1 year after cell infusion, or male subjects with partners planning pregnancy within 1 year after infusion;\n* Having other conditions deemed unsuitable for enrollment by the investigator.",{"count":52,"type":21},7,[54],"EARLY_PHASE1","This study is a single-arm, open-label, dose-escalating trial to explore the safety, tolerability and pharmacokinetic\u002Fpharmacodynamics characteristics of anti human CI-135 (FLT3) CAR-T Injection , and to preliminarily observe the efficacy of the trial drug in patients with relapsed\u002Frefractory Acute Myeloid Leukemia.",[57],"Acute Myeloid Leukemia (AML)","2025-01-05",{"date":60,"type":36},"2025-01-07",{"date":62,"type":36},"2022-01-26",{"date":64,"type":21},"2026-12-31",{"name":41,"class":42},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":43},"100519557","early-phase-1-to-evaluate-the-safety-and-efficacy-of-human-bcma-targeted-car-nk-cells-injection-for-subjects-with-rr-mm-or-pcl-100519557","NCT06045091","To Evaluate the Safety and Efficacy of Human BCMA Targeted CAR-NK Cells Injection for Subjects With R\u002FR MM or PCL","A Early Phase 1 Clinical Trial to Evaluate the Safety and Efficacy of Human BCMA Targeted CAR-NK Cells Injection for Subjects With Relapsed\u002FRefractory Multiple Myeloma or Plasma Cell Leukemia","Inclusion Criteria:Subjects must meet all of the following criteria to be enrolled:\n\n* Subjects volunteer to participate in clinical trials, understand and sign the informed consent document, be willing to complete all the trial procedures;\n* 18 years and older, Male and female;\n* Expected survival \\> 12 weeks;\n* Documented evidence of multiple myeloma at diagnosis as defined by IMWG updated criteria (2014), or plasma cell leukemia at diagnosis as defined by Diagnosis and therapeutic criteria of hematologic disease (4th edition);\n* One of the following indicators is satisfied:\n\n  1. Serum M protein: IgG M protein ≥5 g\u002FL; or IgA M protein ≥5 g\u002FL; or IgD M protein and IgD \\>ULN;\n  2. Urine M protein ≥200 mg\u002F24h;\n  3. Affected serum free light chain ≥100 mg\u002FL and Serum free light chain ratio is abnormal;\n  4. Clonal bone marrow plasma cells ≥10 % for non-secretory myeloma;\n* Patients with relapsed\u002Frefractory multiple myeloma or plasma cell leukemia, satisfying:\n\n  1. Patients have received at least 3 prior MM or PCL treatment regimens containing at least one proteasome inhibitor and one immunomodulatory;\n  2. Progress is documented within 60 days of the most recent anti-tumor treatment, or efficacy assessment does not reach minimal response(MR) or above;\n* Liver, kidney and cardiopulmonary functions meet the following requirements:\n\n  1. Creatinine clearance rate (estimated by CockcroftGault formula) ≥30mL\u002Fmin;\n  2. Left ventricular ejection fraction \\> 50%;\n  3. Baseline peripheral oxygen saturation \\> 95%;\n  4. Total bilirubin≤ 2×ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN;\n* Blood routine examination satisfying hemoglobin≥60 g\u002FL, neutrophils≥ 1.0×10\\^9\u002FL, and platelets≥30×10\\^9\u002FL, can complete this trial according to the judgement of investigators.\n\nExclusion Criteria:Any one of the following conditions cannot be selected as a subject：\n\n* Accompanied by other uncontrolled malignancies;\n* Subjects with positive Hepatitis B surface antigen(HBsAg) or Hepatitis B core antibody (HBcAb) and hepatitis B virus (HBV) DNA titers higher than the lower limit of the normal range of the investigative site; Hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; Human Immunodeficiency Viral (HIV) antibody positive; syphilis primary screening antibody positive;\n* Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), need drug therapy of severe arrhythmia, liver, kidney, or metabolic disease;\n* Subjects who are considered unsuitable to participate in this trial by the investigator.\n* Pregnant or lactating woman, and female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner plans to have a pregnancy within 1 year after cell transfusion;\n* Received CAR-NK treatment or other gene therapies before enrollment;\n* Subjects who have a disease that affects the signing of written informed consent or who are unable to comply with research procedures; or who are unwilling or unable to comply with research requirements;\n* Subjects who have had severe immediate hypersensitivity reactions to any drugs used in this research;\n* Active or uncontrollable infection requiring systemic therapy within 14 days prior to enrollment;\n* In the past two years, the terminal organ was damaged due to autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus), or the systemic use of immunosuppressive or other systemic disease control drugs was required;\n* Patients with symptoms of central nervous system.",{"count":20,"type":21},[54],"This study is a single-arm, open-label, dose-escalation trial to explore the safety, tolerability and pharmacokinetic\u002Fpharmacodynamics characteristics of human BCMA targeted CAR-NK Cells injection, and to preliminarily observe the efficacy of the trial drug in patients with relapsed\u002Frefractory multiple myeloma or plasma cell leukemia.",[77,78],"Multiple Myeloma","Plasma Cell Leukemia",[80,81,77,78,82],"BCMA","CAR-NK","Relapsed \u002FRefractory","2023-09-13",{"date":85,"type":36},"2023-09-21",{"date":87,"type":36},"2023-07-04",{"date":89,"type":21},"2027-09-30",{"name":41,"class":42},{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":22,"phases":101,"briefSummary":103,"conditions":104,"keywords":105,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},"100484956","phase-2-human-bcma-targeted-t-cells-injectionbcma-car-tfor-subjects-with-rr-mm-100484956","NCT05594797","Human BCMA Targeted T Cells Injection（BCMA CAR-T）for Subjects With R\u002FR MM","A Phase Ⅱ Clinical Study Evaluating the Efficacy and Safety of Human BCMA Targeted T Cells Injection Therapy for Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:Subjects must meet all of the following criteria to be enrolled:\n\n* Subjects volunteer to participate in clinical trails, understand and inform the trials and sign informed consent form, be willing to complete all the trial procedures;\n* 18 to 75 years old (including cut-off value)，gender is not limited;\n* Expected survival \\> 12 weeks;\n* Previously diagnosed as multiple myeloma by the International Myeloma Working Group（IMWG） updated criteria;\n* One of the following indicators is satisfied:\n\n  1. Serum M protein ≥ 5 g\u002FL;\n  2. Urine M protein ≥ 200 mg\u002F24h;\n  3. Affected serum free light chain ≥ 100 mg\u002FL and Serum free light chain ratio is abnormal ;\n* Patients with relapsed\u002Frefractory multiple myeloma, satisfying:\n\n  1. Patients have received at least 3 prior MM treatment regimens containing at least one proteasome inhibitor and one immunomodulator;\n  2. Progress is documented within 12 months of the most recent antimyeloma treatment, or efficacy assessment does not reach minimal response(MR) or above or progression within 60 days of the most recent antimyeloma treatment;\n* ECOG score 0-2;\n* Autologous hematopoietic stem cell transplantation is not possible or relapses after autologous hematopoietic stem cell transplantation, but requires further treatment at the investigator's discretion；\n* Liver, kidney and cardiopulmonary functions meet the following requirements:\n\n  1. Creatinine clearance rate (estimated by CockcroftGault formula)≥40mL\u002Fmin;\n  2. Total bilirubin≤2×ULN; Alanine aminotransferase (ALT) ≤2.5×ULN and aspartate aminotransferase (AST)≤2.5×ULN;\n  3. Left ventricular ejection fraction \\>50%;\n  4. Baseline peripheral oxygen saturation\\>95%;\n* The venous access required for collection can be established, no contraindications to leukocyte collection, and leukepheresis can be carried according to the judgement of investigators, satisfying hemoglobin≥70g\u002FL,platelets ≥50×10\\^9 \u002F L, neutrophils ≥1.0×10\\^9\u002FL.\n\nExclusion Criteria:Any one of the following conditions cannot be selected as a subject：\n\n* Subjects have a history of central nervous system (CNS) diseases such as seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, psychosis; known or history of active central nervous system (CNS) involvement or presentation of multiple myeloma meninge\u002Fmeningeal involvement;\n* Subjects with plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, or primary light chain amyloidosis;\n* Accompanied by other uncontrolled malignancies, in addition to adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, ductal carcinoma in situ after radical resection and thyroid cancer after radical resection ;\n* Any uncontrollable active infection, including but not limited to active tuberculosis; fungal, bacterial, viral, or other infections that are uncontrollable or require systemic intravenous therapy are present or suspected within 14 days prior to enrollment;\n* Subjects with positive Hepatitis B surface antigen(HBsAg) or Hepatitis B core antibody (HBcAb) and hepatitis B virus (HBV) DNA titers higher than the lower limit of the normal range of the investigative site); Hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; Human Immunodeficiency Viral (HIV) antibody positive; syphilis positive;\n* Any uncontrolled systemic diseases, including but not limited to unstable angina pectoris, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ Ⅲ), uncontrolled diabetes mellitus (glycosylated hemoglobin HbAlc \\>8% at screening)，severe arrhythmia, liver, kidney, or metabolic diseases that are poorly controlled by medications;\n* Subjects who have a history of pacemaker and brain pacemaker implantation;\n* Subjects who have received CAR-T treatment or other genetically modified cell therapies, as well as other BCMA-targeting drugs;\n* Subjects with any hematopoietic stem cell transplant performed within the first two months of screening, or any immunosuppressive therapy due to graft-versus-host disease performed during the screening period;\n* Subjects who were receiving systemic steroid treatment within 14 days before the screening period and who were judged by the investigator to require long-term use of systemic steroid therapy during treatment (except inhalation or topical use); or subjects who received any systemic anti-tumor therapy ( except for local anti-tumor therapy) ;\n* Subjects who have received live attenuated vaccine within 4 weeks prior to apheresis;\n* In the past two years, the terminal organ was damaged due to autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus), or the systemic use of immunosuppressive or other systemic disease control drugs was required;\n* Pregnant or lactating woman, or planned pregnancy during treatment or within 1 year after treatment, or male subject whose partner plans to have a pregnancy within 1 year after cell transfusion; except participants of childbearing age are willing to use a very effective and reliable method of contraception for 1 year after study treatment;\n* Subjects who have a disease that affects the signing of written informed consent or who are unable to comply with research procedures; or who are unwilling or unable to comply with research requirements;\n* Subjects who have had severe immediate hypersensitivity reactions to any drugs used in this research;\n* Subjects who are considered unsuitable to participate in this trial by the investigator.","75 Years",{"count":100,"type":21},100,[102],"PHASE2","A Phase Ⅱ Clinical Study Evaluating the Efficacy and Safety of Human BCMA Targeted T Cells Injection（BCMA CAR-T） Therapy for R\u002FR MM.\n\nPatients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of BCMA CAR+ T cells.",[77],[80,106,107,77],"CAR-T","Relapsed\u002FRefractory","2022-12-07",{"date":110,"type":36},"2022-12-09",{"date":112,"type":36},"2022-07-12",{"date":114,"type":21},"2027-07-31",{"name":41,"class":42},2,{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":125,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":43},"100472772","phase-2-human-cd19-targeted-t-cells-injectioncd19-car-t-therapy-for-relapsed-and-refractory-b-cell-non-hodgkins-lymphoma-100472772","NCT05436223","Human CD19 Targeted T Cells Injection(CD19 CAR-T) Therapy for Relapsed and Refractory B-cell Non-Hodgkin's Lymphoma","A Phase Ⅱ Clinical Study Evaluating the Efficacy and Safety of Human CD19 Targeted T Cells Injection (CD19 CAR-T) Therapy for Relapsed and Refractory B-cell Non-Hodgkin's Lymphoma","Inclusion Criteria:Subjects with relapsed\u002Frefractory B-cell non-Hodgkin's lymphoma\n\n* Age≥18 years old，gender is not limited;\n* Expected survival \\> 12 weeks;\n* ECOG score 0-2;\n* B-cell non-Hodgkin's lymphoma confirmed by cytology or histopathology according to the 2016 World Health Organization (WHO) classification and diagnostic criteria, including: diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed filter Alveolar lymphoma (TFL) and high-grade B-cell lymphoma (HGBCL);\n* Pathology demonstrated that B-cell non-Hodgkin's lymphoma and who meet one of the following conditions:\n\n  1. Relapsed and refractory B-cell non-Hodgkin's lymphoma, after standard first-line treatment and at least 2 courses of second-line treatment without remission and relapse (the previous use of CD20-targeted drugs and anthracyclines were needed);\n  2. Relapse of B-cell non-Hodgkin lymphoma after stem cell transplantation, regardless of previous treatments.\n* The venous access required for collection can be established and leukepheresis can be carried according to the judgement of investigators, satisfying hemoglobin≥80g\u002FL, neutrophils ≥1.0×10\\^9\u002FL, platelets ≥75×10\\^9 \u002F L;\n* According to the Lugano 2014 criteria, there should be at least one measurable tumor lesion;\n* Liver, kidney and cardiopulmonary functions meet the following requirements:\n\n  1. Serum creatinine≤1.5×ULN or creatinine clearance rate≥50mL\u002Fmin (GockcroftGault formula);\n  2. Cardiac ejection fraction \\>50%, no clinically significant pericardial effusion detected, no clinically significant pleural effusion detected;\n  3. Baseline blood oxygen saturation\\>92%;\n  4. Total bilirubin≤1.5×ULN(Gilbert syndrome≤5×ULN);\n  5. ALT and AST≤3×ULN (AST and ALT ≤5×ULN in patients with liver metastases);\n* Able to understand and sign the Informed Consent Document.\n\nExclusion Criteria:Any one of the following conditions cannot be selected as a subject：\n\n* Malignant tumors other than diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (TFL), and high-grade B-cell lymphoma (HGBCL) within 5 years prior to screening, in addition to adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, ductal carcinoma in situ after radical resection and thyroid cancer after radical resection ;\n* Subjects with positive Hepatitis B surface antigen(HBsAg) or Hepatitis B core antibody (HBcAb) and positive peripheral blood hepatitis B virus (HBV) DNA titers (higher than the upper limit of the normal range of the investigative site); Hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; Human Immunodeficiency Viral (HIV) antibody positive; syphilis positive;\n* Any uncontrolled systemic diseases, including but not limited to active infection (except for localized infection), uncontrolled angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), need drug therapy of severe arrhythmia, liver, kidney, or metabolic disease;\n* Any other uncontrolled active disease that precludes participation in the trial;\n* Any circumstances that the investigator believes will compromise the safety of the subject or interfere with the purpose of the study;\n* Pregnant or lactating woman, or planned pregnancy during treatment or within 1 year after treatment, or male subject whose partner plans to have a pregnancy within 1 year after cell transfusion;\n* Active or uncontrollable infection requiring systemic therapy within 14 days prior to enrollment (except uncomplicated urinary tract infection or upper respiratory tract infection);\n* Subjects who were receiving systemic steroid treatment within 14 days before enrollment and who were judged by the investigator to require long-term use of systemic steroid therapy during treatment (except inhalation or topical use); or subjects who received any systemic anti-tumor therapy ( except for local anti-tumor therapy) ;\n* Subjects who have received CAR-T treatment or other gene-modified cell therapy before enrollment;\n* Patients with symptoms of central nervous system or brain metastasis or have received treatment for central nervous system or brain metastasis (radiotherapy, surgery or other treatment) within 3 months before enrollment;\n* Subjects who have a disease that affects the signing of written informed consent or who are unable to comply with research procedures; or who are unwilling or unable to comply with research requirements;\n* Subjects who are considered unsuitable to participate in this trial by the investigator.",{"count":100,"type":21},[102],"A Phase Ⅱ Clinical Study Evaluating the Efficacy and Safety of Human CD19 Targeted T Cells Injection (CD19 CAR-T) Therapy for R\u002FR B-NHL.\n\nPatients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19 CAR+ T cells.",[128],"B-cell Non-Hodgkin's Lymphoma",[130,131,106,107],"B-cell non-Hodgkin's Lymphoma","CD19","2022-06-29",{"date":134,"type":36},"2022-07-05",{"date":136,"type":36},"2021-08-09",{"date":138,"type":21},"2026-08-09",{"name":41,"class":42},""]