[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hebei Senlang Biotechnology Inc., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":230},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,43,73,96,116,137,163,185,206],{"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":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100626449","early-phase-1-autologous-car-t-cell-therapy-for-refractory-and-relapsing-ulcerative-colitis-a-single-center-exploratory-study-100626449",false,"NCT07435779","Autologous CAR-T Cell Therapy for Refractory and Relapsing Ulcerative Colitis: A Single-Center Exploratory Study","A Single-Center, Open-Label, Single-Arm Exploratory Clinical Study of Autologous CAR-T Cell Therapy Injection for the Treatment of Refractory and Relapsing Ulcerative Colitis","Inclusion Criteria:\n\n* The subject or guardian must provide voluntary informed consent;\n* Diagnosis based on the \"Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (2023, Xi'an)\": Patients diagnosed with UC (based on comprehensive evaluation including clinical, imaging, pathological, and endoscopic assessments), with a follow-up period of more than 3 months;\n* Moderate to severe active ulcerative colitis: Patients meeting the criteria of a clinical modified Mayo score of 6-12 points and an endoscopic Mayo score (ES) ≥ 2 points (within 10 days prior to baseline);\n* Previous treatments with all domestically approved medications for UC, including conventional immunosuppressive drugs, biologics, and small molecule drugs, have failed;\n* Hematological, liver and kidney function, cardiopulmonary function, and coagulation function meet specific criteria.\n\nExclusion Criteria:\n\n* Women who are pregnant or lactating;\n* Any condition that, in the judgment of the Investigator, could increase the subject's risk or compromise the interpretation of the trial results;\n* Diagnosed with CD (Crohn's Disease) or indeterminate colitis (IBD-unclassified), or other types of colitis or enteritis that may confound efficacy assessment;\n* Currently diagnosed with fulminant colitis and\u002For toxic megacolon;\n* UC limited to the rectum;\n* Currently or likely to require colostomy or ileostomy;\n* Has previously undergone total proctocolectomy or partial colectomy.\n* Patients who test positive for hepatitis B surface antigen (HBsAg) should be excluded; if HBsAg is negative but hepatitis B core antibody (HBcAb) is positive, and peripheral blood HBV DNA is above the detection limit, they should be excluded; patients who test positive for hepatitis C virus (HCV) antibodies and HCV RNA should be excluded; patients who test positive for human immunodeficiency virus (HIV) antibodies; patients who test positive for cytomegalovirus (CMV) DNA; patients who test positive for Epstein-Barr virus (EBV) DNA; patients who test positive for both treponemal-specific antibodies and non-specific antibodies for syphilis should be excluded.\n* Any uncontrolled active infection present at the time of signing the ICF.\n* Subjects who have had severe, opportunistic, or chronic\u002Frecurrent extra-intestinal infections within 2 months prior to screening; evidence of active\u002Finfectious herpes zoster infection within 8 weeks prior to screening; active tuberculosis or latent tuberculosis infection present at screening.","ALL","18 Years","60 Years",{"count":20,"type":21},12,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","A Single-Center, Open-Label, Single-Arm Exploratory Clinical Study on the Use of Autologous CAR-T Cell Therapy Injection for the Treatment of Refractory and Relapsing Ulcerative Colitis: A Preliminary Exploration of 12-Week Clinical Remission with Autologous CAR-T Cell Injection in Refractory and Relapsing Ulcerative Colitis.",[27],"UC",[29],"UC；CAR-T","RECRUITING","2026-02-25",{"date":33,"type":34},"2026-02-27","ACTUAL",{"date":36,"type":34},"2026-02-04",{"date":38,"type":21},"2028-02-04",{"name":40,"class":41},"Hebei Senlang Biotechnology Inc., Ltd.","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100625378","phase-1-phase-iii-study-of-senl103-for-relapsed-or-refractory-multiple-myeloma-a-multicenter-open-label-single-arm-trial-100625378","NCT07421856","Phase I\u002FII Study of SENL103 for Relapsed or Refractory Multiple Myeloma: A Multicenter, Open-Label, Single-Arm Trial.","A Multicenter, Open-label, Single-Arm Phase I\u002FII Clinical Study to Evaluate the Safety and Efficacy of SENL103 Autologous T Cell Injection (S103) in Subjects With Relapsed or Refractory Multiple Myeloma.","Inclusion Criteria:\n\n* 1.The subject must understand and voluntarily sign the informed consent form (ICF) before any study-related assessments\u002Fprocedures.; 2.Male or female subjects aged 18 to 70 years (inclusive) at the time of signing the informed consent form; 3.Life expectancy of no less than 12 weeks; 4.ECOG performance status of 0 to 1; 5.Diagnosis of relapsed\u002Frefractory multiple myeloma (RRMM) according to the International Myeloma Working Group (IMWG) diagnostic criteria, with at least 3 prior lines of therapy, including regimens based on proteasome inhibitors, immunomodulatory agents, and CD38 monoclonal antibodies; disease progression documented by radiographic evidence within 12 months following the most recent anti-myeloma therapy.; 6.The subject must have measurable multiple myeloma disease, which must meet at least one of the following criteria:\n\n  1. Bone marrow cytology, bone marrow biopsy tissue, or flow cytometry showing ≥5% clonal plasma cells or immature plasma cells;\n  2. Serum M-protein levels: IgG type M-protein ≥10 g\u002FL; or IgA, IgD, IgE, IgM type M-protein ≥5 g\u002FL;\n  3. 24-hour urine M-protein level ≥200 mg;\n  4. For light chain multiple myeloma without measurable serum or urine lesions: serum free light chain (sFLC) ≥100 mg\u002FL and abnormal serum κ\u002Fλ free light chain ratio;\n\nExclusion Criteria:\n\n* 1.Subjects with asymptomatic (smoldering) multiple myeloma; 2.Subjects with multiple myeloma with extramedullary lesions (excluding isolated extramedullary lesions with a maximum cross-sectional diameter ≤3 cm)； 3.Subjects with active plasma cell leukemia (defined as peripheral blood plasma cells \\>5%), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloidosis at screening; 4.Subjects with clinically significant cardiovascular disease, including any of the following:\n\n  1. QTc interval \\>470 ms (QTc interval corrected using the Fridericia formula);\n  2. New York Heart Association (NYHA) Class II or higher heart failure;\n  3. Unstable angina or acute myocardial infarction within 6 months prior to signing the informed consent form (ICF);\n  4. Left ventricular ejection fraction (LVEF) \\\u003C50%;\n  5. Poorly controlled hypertension (systolic blood pressure ≥160 mm Hg and\u002For diastolic blood pressure ≥100 mm Hg); Arrhythmia that is either clinically significant or requires antiarrhythmic therapy (e.g., persistent ventricular tachycardia, ventricular fibrillation, torsades de pointes, or complete left bundle branch block); 5.Subjects who have previously received BCMA-targeted therapies, BCMA CAR-T therapy, or other cellular therapies 6.Subjects who have previously received the following antineoplastic therapies: monoclonal antibody treatment for multiple myeloma within 21 days prior to autologous stem cell collection, cytotoxic chemotherapy or proteasome inhibitors within 14 days prior to autologous stem cell collection, immunomodulatory agents within 7 days prior to autologous stem cell collection, or any other antineoplastic therapies within 14 days or at least 5 half-lives (whichever is longer) prior to autologous stem cell collection; 7.Subjects with interstitial lung disease or interstitial pneumonia at the time of signing the ICF; 8.Subjects with active autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, and psoriasis) or other conditions requiring immunosuppressive therapy (except for low-dose corticosteroids) at screening; 9.Subjects who have received live or inactivated vaccines within 28 days prior to signing the ICF;","70 Years",{"count":52,"type":21},24,[54,55],"PHASE1","PHASE2","To Evaluate Safety and Efficacy of S103 for Treating Relapsed or Refractory Multiple Myeloma",[58,59],"Multiple Myeloma in Relapse","Multiple Myeloma Refractory",[61,62,63],"S103","Multiple Myeloma","CAR-T","NOT_YET_RECRUITING","2026-02-11",{"date":67,"type":34},"2026-02-19",{"date":69,"type":21},"2026-02-01",{"date":71,"type":21},"2030-02-01",{"name":40,"class":41},{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":42},"100611732","phase-2-assessment-of-senlb19-car-t-cells-in-relapsedrefractory-cd19-b-all-100611732","NCT07244406","Assessment of Senl_B19 CAR-T Cells in Relapsed\u002FRefractory CD19+ B-ALL","A Phase II, Open-Label, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Senl_B19 Autologous Anti-CD19 CAR-T Cells in Subjects With Relapsed or Refractory CD19-Positive B-Cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* 1.Sign the informed consent and be willing and able to comply with the visit, treatment regimen, laboratory examination and other requirements of the study as stipulated in the trial flow chart; 2.Male or female subjects. Age between 3 and 25 years (inclusive) at the time of ICF signing； 3.Confirmed diagnosis of relapsed\u002Frefractory B-ALL at ICF signing; 4.\\>5% blasts on screening bone marrow biopsy\u002Faspirate; 5.CD19+ malignant cells by flow cytometry (bone marrow or peripheral blood) at screening; 6.Patients with Ph+ ALL are eligible if they meet the relapsed\u002Frefractory criteria and have either: failed ≥2 TKI regimens (unless they have a T315I mutation), demonstrated TKI intolerance, or have a contraindication to TKIs; 7.Estimated survival time\\>3 months.\n\nExclusion Criteria:\n\n* 1.Relapse of isolated extramedullary disease; 2.Burkitt lymphoma\u002Fleukemia； 3.Active acute or moderate-to-severe chronic GVHD within 4 weeks prior to ICF signing. Or, any systemic GVHD treatment within 4 weeks prior to infusion; 4.No uncontrolled active infection at the time of ICF signing or apheresis.; 5.Prior receipt of any CAR-T therapy or other cellular\u002Fgene therapy before screening; 6.Received investigational drugs or systemic anti-tumor therapy within 4 weeks or 5 half-lives (whichever longer) prior to apheresis; 7.Active interstitial lung disease\u002Fpneumonitis at the time of ICF signing; 8.Subjects whom the Investigator considers unable to comply with the study protocol or who are otherwise not an appropriate candidate for the study for any reason;","3 Years","25 Years",{"count":83,"type":21},59,[55],"To evaluate the efficacy and safety of S1904 in patients with relapsed or refractory CD19+B-ALL.",[87],"B-ALL","2025-11-17",{"date":90,"type":34},"2025-11-24",{"date":92,"type":34},"2025-01-10",{"date":94,"type":21},"2028-12-31",{"name":40,"class":41},{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":110,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":4},"100611730","phase-2-phase-ii-trial-of-s101-autologous-anti-cd7-car-t-cells-in-patients-with-rr-t-lblall-100611730","NCT07244380","Phase II Trial of S101 Autologous Anti-CD7 CAR-T Cells in Patients With R\u002FR T-LBL\u002FALL.","A Phase II Clinical Trial of S101 Autologous CAR-T Cell Injection for the Treatment of CD7-Positive Relapsed or Refractory T-Lymphoblastic Lymphoma\u002FLeukemia (T-LBL\u002FALL).","Inclusion Criteria:\n\n* 1.The subject or guardian must provide voluntary informed consent; 2.Heavily pretreated patients with relapsed or refractory T-LBL\u002FALL who lack effective therapeutic alternatives; 3.At screening, CD7 positivity of tumor cells must be documented by flow cytometry (on bone marrow or peripheral blood samples) and\u002For by immunohistochemistry (IHC) confirming CD7 expression on an extramedullary lesion biopsy; 4.If malignant cells are detected in the peripheral blood at screening, they must demonstrate a CD4-negative and CD8-negative (double-negative) immunophenotype as assessed by flow cytometry; 5.Male or female subjects, aged 18 to 75 years (inclusive); 6.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2; 7.Estimated survival time\\>12 weeks.\n\nExclusion Criteria:\n\n* 1.Patients with a history of allogeneic hematopoietic stem cell transplantation within the past 6 months are excluded; 2.Active or uncontrolled infection requiring systemic treatment at screening, excluding mild genitourinary and upper respiratory infections； 3.Participation in another clinical trial within 4 weeks prior to signing the informed consent form (ICF), OR the date of ICF signing occurring within 5 half-lives of the last dose from a previous investigational drug trial (whichever timeframe is longer); 4.Patients with previous treatment involving CAR-T cells or other gene-modified cell therapies are excluded; 5.Patients with acute GVHD (aGVHD) or moderate-to-severe chronic GVHD (cGVHD) within 4 weeks prior to screening, or those who have received systemic pharmacologic therapy for GVHD within 4 weeks prior to infusion; 6.Patients who have received extensive radiotherapy within 4 weeks prior to ICF signing, with the exception of non-target lesion radiotherapy administered for symptomatic palliation that may be permitted during the study period; 7.Women who are pregnant or lactating; 8.Any condition that, in the judgment of the Investigator, could increase the subject's risk or compromise the interpretation of the trial results.","75 Years",{"count":105,"type":21},38,[55],"To Evaluate the Efficacy and safety of S101 for Treating CD7-Positive Relapsed or Refractory T-LBL\u002FALL.",[109],"T Lymphoblastic Leukemia\u002FLymphoma",{"date":90,"type":34},{"date":112,"type":21},"2025-11-28",{"date":114,"type":21},"2028-06-30",{"name":40,"class":41},{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":42},"100605336","phase-1-anti-cd19-chimeric-antigen-receptor-t-cells-for-refractory-autoimmune-diseases-100605336","NCT07161193","Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Autoimmune Diseases","Inclusion Criteria:\n\n* 1.Refractory Moderate-to-Severe Systemic lupus erythematosus (SLE) 1.1.Age 18-70 years. 1.2.Estimated life expectancy ≥ 3 months. 1.3.Documented disease history and diagnosis for ≥ 6 months prior to screening. 1.4.Participants must agree to use effective contraception throughout the study; women of child-bearing potential must have a negative pregnancy test.\n\n1.5.Signed informed consent, agreement to the treatment protocol, and willingness to attend follow-up evaluations per schedule.\n\n1.6.Relevant medical history and clinical manifestations: provide a copy of inpatient records from a tertiary hospital or outpatient records and diagnostic certificates within the last 3 months.\n\n1.7.Required laboratory tests, including but not limited to: CBC, urinalysis, ANA, anti-dsDNA, ENA panel, C3\u002FC4, immunoglobulins, antiphospholipid antibodies, etc.\n\n1.8.Meets current international or domestic classification criteria: the 1997 ACR SLE classification criteria OR the 2019 EULAR\u002FACR SLE classification criteria, and is judged to have moderate-to-severe SLE.\n\n1.9.SELENA-SLEDAI score ≥ 8; PGA ≥ 1; and at least one BILAG-2004 organ-system score of 1A or 2B.\n\n1.10.Inadequate response to, or intolerance of, at least 12 weeks of standardized therapy prior to screening.\n\n2.Refractory Idiopathic inflammatory myopathy (IIM) 2.1.Age 18-70 years. 2.2.Estimated life expectancy ≥ 3 months. 2.3.Documented disease history and diagnosis for ≥ 6 months prior to screening. 2.4.Participants must agree to use effective contraception throughout the study; women of child-bearing potential must have a negative pregnancy test.\n\n2.5.Signed informed consent, agreement to the treatment protocol, and willingness to attend follow-up evaluations per schedule.\n\n2.6.Relevant medical history and clinical manifestations: provide a copy of inpatient records from a tertiary hospital or outpatient records and diagnostic certificates within the last 3 months.\n\n2.7.Fulfillment of the 2017 EULAR\u002FACR classification criteria for dermatomyositis or polymyositis.\n\n2.8.Inadequate response to, or intolerance of, at least 12 weeks of standardized therapy prior to screening.\n\n3.Refractory Systemic sclerosis (SSc) 3.1.Age 18-70 years. 3.2.Estimated life expectancy ≥ 3 months. 3.3.Documented disease history and diagnosis for ≥ 6 months prior to screening. 3.4.Participants must agree to use effective contraception throughout the study; women of child-bearing potential must have a negative pregnancy test.\n\n3.5.Signed informed consent, agreement to the treatment protocol, and willingness to attend follow-up evaluations per schedule.\n\n3.6.Relevant medical history and clinical manifestations: provide a copy of inpatient records from a tertiary hospital or outpatient records and diagnostic certificates within the last 3 months.\n\n3.7.Fulfillment of the 2013 ACR\u002FEULAR classification criteria for systemic sclerosis, with clinical or radiographic evidence of pulmonary involvement.\n\n3.8.Required laboratory tests, including but not limited to: CBC, urinalysis, ANA, anti-dsDNA, ENA panel, C3\u002FC4, immunoglobulins, etc.\n\n3.9.Classification per current international or domestic standards: the 1980 ACR criteria for SSc OR the 2013 ACR\u002FEULAR criteria for SSc.\n\n3.10.Inadequate response to, or intolerance of, at least 12 weeks of standardized therapy prior to screening.\n\n4.Refractory Pemphigus 4.1.Age 18-70 years. 4.2.Estimated life expectancy ≥ 3 months. 4.3.Documented disease history and diagnosis for ≥ 6 months prior to screening. 4.4.Participants must agree to use effective contraception throughout the study; women of child-bearing potential must have a negative pregnancy test.\n\n4.5.Signed informed consent, agreement to the treatment protocol, and willingness to attend follow-up evaluations per schedule.\n\n4.6.Relevant medical history and clinical manifestations: provide a copy of inpatient records from a tertiary hospital or outpatient records and diagnostic certificates within the last 3 months.\n\n4.7.Fulfillment of at least one clinical manifestation plus one histopathological or immunodiagnostic criterion, OR at least two clinical manifestations plus two immunodiagnostic criteria:\n\n* Clinical manifestations: flaccid cutaneous bullae and fragile blisters that rupture easily, resulting in persistent erosions; mucosal blisters or erosions; positive Nikolsky sign.\n* Histopathology: intraepidermal or intraepithelial acantholysis.\n* Immunodiagnostic criteria: direct immunofluorescence (DIF) showing intercellular IgG and\u002For complement deposition in epidermal\u002Fepithelial cells of lesional or perilesional normal skin; positive serum anti-epithelial cell antibodies by indirect immunofluorescence; positive serum anti-desmoglein antibodies by ELISA.\n\n4.8.Pemphigus Disease Area Index (PDAI) ≥ 9 (moderate 9-24, severe ≥ 25). 4.9.Inadequate response to, or intolerance of, at least 12 weeks of standardized therapy prior to screening.\n\n5.Refractory Moderate-to-Severe Psoriasis 5.1.Age 18-70 years. 5.2.Estimated life expectancy ≥ 3 months. 5.3.Documented disease history and diagnosis for ≥ 6 months prior to screening. 5.4.Participants must agree to use effective contraception throughout the study; women of child-bearing potential must have a negative pregnancy test.\n\n5.5.Signed informed consent, agreement to the treatment protocol, and willingness to attend follow-up evaluations per schedule.\n\n5.6.Relevant medical history and clinical manifestations: provide a copy of inpatient records from a tertiary hospital or outpatient records and diagnostic certificates within the last 3 months.\n\n5.7.In accordance with the 2023 Chinese Guidelines for the Diagnosis and Treatment of Psoriasis, meets the diagnostic criteria for moderate-to-severe plaque psoriasis: dark-red or infiltrated erythematous plaques covered by white\u002Fsilvery scales, demonstrating the wax-drip, film, and Auspitz signs.\n\n5.8.At screening: Body Surface Area (BSA) involvement ≥ 10%, Psoriasis Area and Severity Index (PASI) ≥ 10, and static Physician's Global Assessment (sPGA) ≥ 3.\n\n5.9.Inadequate response to, or intolerance of, at least 12 weeks of standardized therapy prior to screening.\n\n6.Refractory Moderate-to-Severe Rheumatoid Arthritis 6.1.Age 18-70 years. 6.2.Estimated life expectancy ≥ 3 months. 6.3.Documented disease history and diagnosis for ≥ 6 months prior to screening. 6.4.Participants must agree to use effective contraception throughout the study; women of child-bearing potential must have a negative pregnancy test.\n\n6.5.Signed informed consent, agreement to the treatment protocol, and willingness to attend follow-up evaluations per schedule.\n\n6.6.Relevant medical history and clinical manifestations: provide a copy of inpatient records from a tertiary hospital or outpatient records and diagnostic certificates within the last 3 months.\n\n6.7.Required laboratory and imaging assessments, including but not limited to: ESR, CRP, rheumatoid factor, ANA, anti-CCP antibodies, and other relevant autoantibodies; bilateral hand\u002Ffoot radiographs.\n\n6.8.Meets current international or domestic classification criteria: the 1987 ACR criteria for RA OR the 2010 ACR\u002FEULAR criteria for RA.\n\n6.9.Inadequate response to, or intolerance of, at least 12 weeks of standardized therapy prior to screening.\n\n7.Refractory ANCA-Associated Vasculitis\u002FNephritis 7.1.Age 18-70 years. 7.2.Estimated life expectancy ≥ 3 months. 7.3.Documented disease history and diagnosis for ≥ 6 months prior to screening. 7.4.Participants must agree to use effective contraception throughout the study; women of child-bearing potential must have a negative pregnancy test.\n\n7.5.Signed informed consent, agreement to the treatment protocol, and willingness to attend follow-up evaluations per schedule.\n\n7.6.Relevant medical history and clinical manifestations: provide a copy of inpatient records from a tertiary hospital or outpatient records and diagnostic certificates within the last 3 months.\n\n7.7.Meets the 2022 ACR\u002FEULAR classification criteria for vasculitis. 7.8.Renal biopsy indicating kidney involvement, or clinical manifestations consistent with small-vessel vasculitis together with positive myeloperoxidase (MPO) or proteinase-3 (PR3) antibodies.\n\n7.9.Persistent or newly emerging renal and\u002For systemic vasculitic manifestations despite maintenance therapy of the same intensity as initial immunosuppressive treatment.\n\n7.10.Inadequate response to, or intolerance of, at least 12 weeks of standardized therapy prior to screening.\n\nExclusion Criteria:\n\n* (1) Clinically significant (as determined by the investigator) history of cardiac, endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major diseases.\n\n  (2) Pregnant or lactating women. (3) History of active tuberculosis (TB) infection within 3 years prior to the screening visit.\n\n  (4) History of traumatic brain injury, altered consciousness, epilepsy, cerebral ischemia, or any cerebrovascular hemorrhagic disorders.\n\n  (5) Prolonged QT interval on ECG or history of severe arrhythmias or other significant cardiac disorders.\n\n  (6) Active infection (excluding uncomplicated urinary tract infection and bacterial pharyngitis).\n\n  (7) Active hepatitis B virus or hepatitis C virus infection. (8) Confirmed positive anti-HIV antibody test. (9) Positive Treponema pallidum antibody test judged by the investigator to be clinically significant.\n\n  (10) Any known or suspected congenital or acquired immunodeficiency that may compromise the subject's immune status.\n\n  (11) Prior treatment with CD19 CAR-T cell therapy or CD19-targeted antibody drugs.\n\n  (12) Prior exposure to any gene therapy. (13) ALT\u002FAST \\> 3× ULN, or bilirubin \\> 2.0× ULN, or serum creatinine \\> 2× ULN, or creatinine clearance \\\u003C 30 mL\u002Fmin.\n\n  (14) Any condition that, in the opinion of the investigator, may increase patient risk or interfere with study results.",{"count":123,"type":21},30,[54,55],"The goal of this study is to evaluate the safety and efficacy of CD19 CAR T cells in the treatment of Refractory Autoimmune Diseases",[127],"Autoimmune Diseases",[127],"2025-09-03",{"date":131,"type":34},"2025-09-08",{"date":133,"type":21},"2025-09-30",{"date":135,"type":21},"2027-11-18",{"name":40,"class":41},{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":16,"minAge":143,"maxAge":103,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":146,"briefSummary":148,"conditions":149,"keywords":152,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":42},"100486743","the-safety-and-efficay-investigation-of-car-t-cell-therapy-for-patients-with-hematological-malignancies-100486743","NCT05618041","The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies","Inclusion Criteria:\n\n* Sign the informed consent and be willing and able to comply with the visit, treatment protocol, laboratory examination, and other requirements of the study as specified in the study procedure sheet;\n* Diagnosed as recurrent or refractory lymphoma, leukemia or myeloma;\n* Tumor cells express targets for CAR-T cell therapy (results: flow cytometry or Immunohistochemical test confirmation);\n* Age 14-75 (including threshold), gender unlimited;\n* Eastern Cooperative Oncology Group (ECOG) score ≤2;\n* HGB ≥ 70g\u002FL (blood transfusion allowed);\n* Liver and kidney functions, heart and lung functions meet the following requirements:\n\n  1. Creatinine ≤ 1.5 × ULN;\n  2. Left ventricular ejection fraction ≥ 50%;\n  3. Blood oxygen saturation\\>90%;\n  4. Total bilirubin ≤ 1.5 × ULN； ALT and AST ≤ 2.5 × ULN;\n* For T cell tumor patients, if tumor cells are detected in peripheral blood during screening, flow cytometry should be used to detect that the tumor cell surface immunophenotype is CD4 and CD8 double negative. If the immunophenotype of peripheral blood tumor cells is not double negative for CD4 and CD8, the condition that the proportion of peripheral blood tumor cells is ≤ 1% shall be met;\n* Subjects with pregnancy plans must agree to use contraception before entering the study and after the study lasts for six months; If the subject is pregnant or suspected of being pregnant, the investigator shall be informed immediately;\n* The subject or guardian understands and signs the informed consent form;\n* Expected survival longer than 3 months.\n\nExclusion Criteria:\n\n* Severe cardiac insufficiency;\n* Have a history of severe lung impairment;\n* Complicated with other advanced malignant tumors;\n* Complicated with severe or persistent infection that cannot be effectively controlled;\n* Complicated with severe autoimmune diseases or congenital immune deficiency;\n* Active hepatitis (HBV DNA or HCV RNA positive);\n* Human immunodeficiency virus (HIV) infection or syphilis infection;\n* Have a history of severe allergy to biological products (including antibiotics);\n* If there is a history of hematopoietic stem cell transplantation, it should be no more than 6 months before the patient receives allogeneic hematopoietic stem cell transplantation;\n* Subjects who received CAR-T therapy or other gene modified cell therapy before screening;\n* Conditions that the investigator believes may increase the risk to the subject or interfere with the outcome of the study.","14 Years",{"count":145,"type":21},50,[147],"NA","To evaluate the tolerability and safety of CAR-T technology in patients with relapsed or refractory hematolymphoid malignancies.",[150,151,62],"Acute Lymphoblastic Leukemia","Lymphoma",[153,154],"CD19,CD20,BCMA","B-ALL\u002FMM\u002FNHL","2025-06-17",{"date":157,"type":34},"2025-06-24",{"date":159,"type":34},"2022-09-07",{"date":161,"type":21},"2027-12-06",{"name":40,"class":41},{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":170,"targetDuration":4,"studyType":22,"phases":172,"briefSummary":173,"conditions":174,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":42},"100469122","phase-1-to-observe-the-dual-target-chimeric-antigen-receptor-t-cells-in-the-treatment-of-b-cell-hematologic-tumors-100469122","NCT05388695","To Observe the Dual-target Chimeric Antigen Receptor T Cells in the Treatment of B Cell Hematologic Tumors","To Observe the Long-term Efficacy and Safety of Dual-target Chimeric Antigen Receptor T Cells in the Treatment of Refractory Relapsed B Cell Hematologic Tumors","Inclusion Criteria:\n\n1. Refractory and relapsed B-cell tumor determined by clinical diagnosis, B cell tumors include the following three categories: B cell acute lymphocyte leucocyte; Inert B cell lymphoma (CLL、 FL、 MZL); Aggressive B-cell lymphoma (DLBCL、 BL、 MCL);\n2. CD19 positive and CD20 positive or CD22 positive were detected by immunohistochemistry or flow cytometry; 3.18 years old≤age≤70 years old;\n\n4.Estimated survival time\\>3 months; 5.ECOG Scores: 0\\~2; 6.There should be at least one measurable tumor foci according to RECIST Version 1.1; 7.The functions of vital organs must meet the following conditions: EF\\>50%, and no obvious abnormality of electrocardiogram; SpO2≥92%; Cr≤1.5ULN; ALTand AST≤5ULN, TBil≤3ULN; 8.Subjects planning to become pregnant must agree to use contraception prior to enrolling in the study and after six months of study duration; inform the investigator immediately if the subject becomes pregnant or suspects pregnancy; 9.The subject or guardian understands and signs the informed consent.\n\nExclusion Criteria:\n\n1. With other diseases that are not effectively controlled, including, but not limited to, persistent or poorly controlled infections symptomatic congestive heart failure unstable angina arrhythmia poorly controlled pulmonary disease or psychiatric disease;\n2. Presence of other malignant tumors;\n3. There are severe infections that cannot be effectively controlled;\n4. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive, peripheral blood hepatitis B virus (HBV)DNA higher than the detection limit should be excluded; If hepatitis C virus (HCV) antibody positive, peripheral blood HCV RNA positive need to exclude; Cytomegalovirus (CMV)DNA positive; Epstein-barr virus DNA positive in peripheral blood;\n5. Known positive serology for human immunodeficiency virus (HIV) or syphilis;\n6. A history of severe allergies to biological products (including antibiotics);\n7. Patients with relapses after allogeneic hematopoietic stem cell transplantation with grade 3-4 acute graft-versus-host disease (GvHD);\n8. Female patients who are under pregnancy and\u002For lactation;\n9. Active autoimmune disease requiring systemic immunosuppressive therapy;\n10. Conditions that the investigator believes may increase the risk to the subject or interfere with the results of the study.",{"count":171,"type":21},100,[54],"To observe the long-term efficacy and safety of dual-target chimeric antigen receptor T cells in the treatment of refractory relapsed B cell hematologic tumors (at least 2 years).",[175,176],"19 and 22+ B Cell Hematologic Tumors","19 and 20+ B Cell Hematologic Tumors","2025-06-16",{"date":179,"type":34},"2025-06-18",{"date":181,"type":34},"2022-04-08",{"date":183,"type":21},"2027-05-30",{"name":40,"class":41},{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":103,"enrollmentInfo":192,"targetDuration":4,"studyType":22,"phases":193,"briefSummary":194,"conditions":195,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":42},"100526563","phase-1-cd7-car-t-in-adults-with-relapsed-or-refractory-t-lblall-clinical-study-100526563","NCT06136364","CD7 CAR-T in Adults With Relapsed or Refractory T-LBL\u002FALL Clinical Study","Open-label, Dose-escalation Phase 1 Clinical Study of SENL101 Autologous T Cell Injection in the Treatment of Adult Patients With Relapsed or Refractory T-LBL\u002FALL","Inclusion Criteria:\n\nAccording to the WHO hematopoietic and lymphoid tissue tumors classification, Subjects with refractory\u002Frelapsing T-LBL\u002FALL has been adequately treated and there is a lack of effective treatment, met one of the following criteria:\n\n1. relapse: Primordial cells (\\>5%)in peripheral blood or bone marrow appeared again after complete remission with standard treatment or Extramedullary disease appears，include：\n\n   1. Early recurrence within 12 months，\n   2. Late recurrence at 12 months or above and with no remission after a course of standard induction chemotherapy，\n   3. Recurrence after autologous or allogeneic hematopoietic stem cell transplantation ;\n2. Refractory: patients who have received at least two courses standard induction regimen and failed to achieve a complete response or complete remission was not achieved after first-line or above salvage treatment;\n3. The tumor cells detected by bone marrow flow cytometry were CD7+ and\u002For extramedullary lesions were diagnosed as CD7+ by pathological immunohistochemistry at the time of enrollment and screening;\n4. If tumor cells were detected in peripheral blood during enrollment and screening, it was required to meet the requirement that the surface immunophenotype of tumor cells was CD4 and CD8 double negative by flow cytometry.\n5. Life expectancy greater than 12 weeks;\n6. ECOG 0-2;\n7. Age 18-75 (upper and lower limits included);\n8. HGB at least 70g\u002FL,PLT 50x109\u002FL, can be transfused;\n9. Liver and kidney functions The cardiopulmonary functions meet the following requirements:\n\n   1. Oxygen saturation under air ≥ 92%;\n   2. LVEF≥50%;\n   3. Total bilirubin \\\u003C3×ULN;\n   4. ALT\u002FAST\\\u003C3×ULN;\n   5. Creatinine \\\u003C1.5×ULN or creatinine clearance rate(Cockroft-Gault)\\>50ml\u002Fmin;\n10. Informed consent explained to, understood by and signed by patient\u002F guardian.\n\nExclusion Criteria:\n\nThose who meet any of the following criteria are not eligible to join the group:\n\n1. New York Heart Association (NYHA) classification ≥ grade III heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris or other clinically prominent heart disease within one year before signing the informed consent form, Or QTc interval \\>480ms at screening (QTc interval calculated by Fridericia formula);\n2. If the patient has a history of hematopoietic stem cell transplantation, 6 months after the patient received allogeneic hematopoietic stem cell transplantation;\n3. Those with active GvHD or those who require immunosuppressive therapy;\n4. Malignancy other than T-cell acute lymphoblastic leukemia\u002Flymphoma within 5 years prior to screening, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer after radical surgery, radical surgery ductal carcinoma in situ;\n5. History of non-neoplastic central nervous system disease (Seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, neuropathy)\n6. Active or uncontrollable infection requiring systemic treatment within 7 days prior to screening (except for mild urogenital infections and upper respiratory tract infections);\n7. History of autoimmune disease (eg, rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease) requiring systemic immunosuppressive\u002Fsystemic disease modulating medication within the past 2 years;\n8. When screening, if the hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HbcAb) is positive, and the peripheral blood hepatitis B virus (HBV) DNA is higher than the detection limit, it needs to be excluded; if the hepatitis C virus (HCV) antibody is positive, the peripheral blood HCV Those with positive RNA need to be excluded; those with positive human immunodeficiency virus (HIV) antibody; those with positive cytomegalovirus (CMV) DNA test; those with positive test for Treponema pallidum specific antibody (TPPA) need to be excluded;\n9. Participate in other clinical trials within 4 weeks before the informed consent is signed, or the date of the informed consent is signed and the last medication of the drug is still within 5 half-lives of the drug (whichever is longer);\n10. History of severe allergy to biological products;\n11. Unstable systemic disease as judged by the investigator: including but not limited to severe liver, kidney or metabolic disease requiring drug therapy;\n12. Pregnant or breastfeeding women, and female subjects planning pregnancy within 2 years of cell infusion or male subjects whose partner is planning pregnancy within 2 years of cell infusion;\n13. Subjects who have received CAR-T therapy or other gene-modified cell therapy prior to screening;\n14. Circumstances that the investigator believes may increase the risk to the subject or interfere with the results of the trial.",{"count":5,"type":21},[54],"To evaluate the tolerability and safety of SENL101 in patients with relapsed or refractory T-LBL\u002FALL.",[196,197],"T-lymphoblastic Lymphoma","T-ALL","2023-11-14",{"date":200,"type":34},"2023-11-18",{"date":202,"type":34},"2023-08-15",{"date":204,"type":21},"2038-08-14",{"name":40,"class":41},{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":16,"minAge":213,"maxAge":50,"enrollmentInfo":214,"targetDuration":4,"studyType":22,"phases":215,"briefSummary":216,"conditions":217,"keywords":219,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":42},"100487385","clinical-study-of-senl-t7-car-t-cells-in-the-treatment-of-relapsed-and-refractory-cd7-acute-t-allt-lbl-100487385","NCT05626400","Clinical Study of Senl-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ Acute T-ALL\u002FT-LBL","Clinical Study of Senl-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ Acute T Lymphoblastic Leukemia and T Lymphoblastic Lymphoma","Inclusion Criteria:\n\n1. Diagnosis of relapsed\u002Frefractory T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma: Induction therapy failed to achieve a complete remission of minor residual negative; Recurrence: after complete remission, any tumor load in the peripheral blood or bone marrow was 5%, or slightly residual positive, or new extramedullary lesions occurred；\n2. CD7 expression in tumor cells was detected by flow cytometry；\n3. Life expectancy greater than 12 weeks；\n4. KPS or Lansky score≥60;\n5. HGB≥70g\u002FL (can be transfused);\n6. 2-70 years old;\n7. Oxygen saturation of blood#90%#;\n8. HGB≥70g\u002FL（blood transfusion allowed）;\n9. Total bilirubin (TBil)≤3 × upper limit normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal;\n10. Informed consent explained to, understood by and signed by patient\u002F guardian.\n\nExclusion Criteria:\n\n1. Any of the following cardiac criteria: Atrial fibrillation\u002Fflutter; Myocardial infarction within the last 12 months; Prolonged QT syndrome or secondary prolonged QT, per investigator discretion. Cardiac echocardiography with LVSF (left ventricular shortening fraction)\\\u003C30% or LVEF(left ventricular ejection fraction)\\\u003C50%; or clinically significant pericardial effusion. Cardiac dysfunction NYHA(New York Heart Association) III or IV (Confirmation of absence of these conditions on echocardiogram within 12 months of treatment);\n2. Has an active GvHD;\n3. Has a history of severe pulmonary function damaging;\n4. With other tumors which is\u002Fare in advanced malignant and has\u002Fhave systemic metastasis;\n5. Severe or persistent infection that cannot be effectively controlled;\n6. Merging severe autoimmune diseases or immunodeficiency disease;\n7. Patients with active hepatitis B or hepatitis C(\\[HBVDNA+\\]or \\[HCVRNA+\\]);\n8. Patients with HIV infection or syphilis infection;\n9. Has a history of serious allergies on Biological products (including antibiotics);\n10. Clinically significant viral infection or uncontrolled viral reactivation of EBV(Epstein-Barr virus), CMV(cytomegalovirus), ADV(adenovirus), BKvirus, or HHV(human herpesvirus)-6;\n11. Presence of symptomatic disorders of the central nervous system, which include but not limited to uncontrolled epilepsy, cerebrovascular ischemia\u002Fhemorrhage, dementia, and cerebellar disease, etc.;\n12. Have received transplant treatment for less than 6 months in prior to enrollment;\n13. Being pregnant and lactating or having pregnancy within 12 months;\n14. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.","2 Years",{"count":171,"type":21},[147],"This is an open, prospective, dose-escalation clinical study to evaluate the safety and efficacy of Senl-T7 in patients with relapsed or refractory CD7+ acute T lymphoblastic leukemia or T lymphoblastic lymphoma.Meanwhile, PK\u002FPD indexes of Senl-T7 were collected.",[218],"T-cell Acute Lymphoblastic Leukemia\u002FLymphoma",[197,220,221,63],"T-LBL","CD7","2022-11-22",{"date":224,"type":34},"2022-11-25",{"date":226,"type":34},"2022-08-29",{"date":228,"type":21},"2027-12-30",{"name":40,"class":41},""]