[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Changzhou No.2 People's Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":164},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,49,78,101,124,145],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":33,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100591308","phase-1-ucar-t-cell-therapy-targeting-cd19-bcma-in-patients-with-relapse-refractory-autoimmune-diseases-100591308",false,"NCT06978738","UCAR T-cell Therapy Targeting CD19\u002F BCMA in Patients With Relapse\u002F Refractory Autoimmune Diseases","A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\n* 1.Age ≥ 18 years old (inclusive), regardless of gender.\n* 2.Positive expression of CD19 on peripheral blood B cells confirmed by flow cytometry.\n* 3.Functional requirements for major organs are as follows:\n\n  1. Bone marrow function must meet: A. Neutrophil count ≥ 0.5×10 \\^ 9\u002FL (no colony-stimulating factor treatment within 2 weeks before examination); B. Hemoglobin ≥ 60g\u002FL; C. Platelets ≥ 30 × 10 \\^ 9\u002FL.\n  2. Liver function: Alanine aminotransferase (ALT) ≤ 3×ULN (excluding ALT elevation due to inflammatory myopathy), aspartate aminotransferase (AST)≤3×Upper limit of normal (ULN) (excluding AST elevation due to inflammatory myopathy), TBIL≤1.5×ULN (or ≤ 3.0×ULN for subjects with Gilbert syndrome);\n  3. Renal function: creatinine clearance rate (CrCl) ≥ 30ml\u002Fminute (calculated by Cockcroft\u002FGault formula, acute CrCl decrease due to the target disease is excluded; LN is exluded);\n* 4.ECOG score 0-1.\n* 5.Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstinence during the study treatment period and for at least 6 months after the end of the study treatment; Female subjects of childbearing potential must have a negative Human chorionic gonadotropin (HCG) test within 7 days before study enrollment and not be lactating.\n* 6.Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.\n* 7.Subjects with relapsed or refractory autoimmune diseases, Including relapsed or refractory Autoimmune Hemolytic Anemia, relapsed or refractory Systemic Lupus Erythematosus, relapsed or refractory or Progressive Systemic Sclerosis, relapsed or refractory or Progressive Inflammatory Myopathy, relapsed or refractory ANCA-Associated Vasculitis, relapsed or refractory Immunoglobulin-G4 related disease and relapsed or refractory Myasthenia Gravis.\n\nExclusion Criteria:\n\n* 1.Subjects with a history of severe drug allergies or allergic constitutions;\n* 2\\. Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections;\n* 3\\. Subjects with insufficient cardiac function;\n* 4\\. Subjects with congenital immunoglobulin deficiencies;\n* 5\\. Subjects with a history of malignant tumors within the past five years, except for the following conditions: non-melanoma skin cancer, stage I tumors with a low recurrence probability after complete resection, clinically localized prostate cancer after treatment, cervical carcinoma in situ confirmed by biopsy or squamous intraepithelial lesion shown by smear, and stable papillary thyroid carcinoma or follicular thyroid carcinoma.\n* 6\\. Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA \\>ULN; subjects positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; individuals positive for human immunodeficiency virus (HIV) antibody; individuals positive for syphilis testing;\n* 7\\. Subjects with mental illness and severe cognitive dysfunction;\n* 8\\. Pregnant women or women planning to conceive;\n* 9.Subjects whom the investigator believes have other reasons that make them unsuitable for inclusion in this study.","ALL","18 Years",{"count":19,"type":20},18,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19\u002FBCMA CAR T-cells in With Relapse\u002FRefractory Autoimmune Diseases.",[26,27,28,29,30,31,32],"Systemic Lupus Erythematosus","Autoimmune Hemolytic Anemia","Myasthenia Gravis","Systemic Sclerosis","ANCA-Associated Vasculitis","Inflammatory Myopathy","IgG4-RD",[34,35],"Universal Allogeneic CAR T-cells","CD19\u002FBCMA CAR T-cells","NOT_YET_RECRUITING","2025-05-11",{"date":39,"type":40},"2025-05-18","ACTUAL",{"date":42,"type":20},"2025-05",{"date":44,"type":20},"2028-11",{"name":46,"class":47},"Changzhou No.2 People's Hospital","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":48},"100590242","effectiveness-of-multimedia-health-education-to-reduce-anxiety-in-patients-with-vitreous-floaters-100590242","NCT06964867","Effectiveness of Multimedia Health Education to Reduce Anxiety in Patients With Vitreous Floaters","Inclusion Criteria:\n\n1. Clinical diagnosis of vitreous floaters;\n2. Be able to complete questionnaires.\n\nExclusion Criteria:\n\n1. Secondary VF requiring surgical intervention;\n2. Coexisting ocular pathologies potentially confounding vitreoretinal anatomy;\n3. History of vitreoretinal surgery.",{"count":56,"type":20},300,[58],"NA","The patients with vitreous floaters were randomly divided into to groups after excluding the possibility of coexisting ocular pathologies potentially confounding visual symptoms or vitreoretinal anatomy. The control group performed conventional oral education. The experimental group conducted multimedia health education activities on the basis of conventional oral education. Their VRQoL (Visual Function Questionnaire-25, VFQ-25) and anxiety status (State-Trait Anxiety Inventory, STAI) were evaluated before education and at the final follow-up. The demographic and clinical characteristics (gender, age, eduaction, duration of vitreous floaters, comorbidities and so on) were collected.",[61,62],"Vitreous Floaters","Anxiety",[64,65,66,67,68],"vitreous floaters","anxiety","health education","STAI","VFQ-25","RECRUITING","2025-05-10",{"date":72,"type":40},"2025-05-14",{"date":74,"type":40},"2023-12-01",{"date":76,"type":20},"2025-06-01",{"name":46,"class":47},{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":48},"100542023","early-phase-1-an-clinical-study-of-cd19-car-nk-cells-for-the-treatment-of-refractory-primary-immune-thrombocytopenia-100542023","NCT06337474","An Clinical Study of CD19 CAR NK Cells for the Treatment of Refractory Primary Immune Thrombocytopenia","An Exploratory Clinical Study of the Safety and Efficacy of CD19 Chimeric Antigen Receptor NK Cell Injections for the Treatment of Refractory Primary Immune Thrombocytopenia","Inclusion Criteria:\n\n1. Age: ≥ 18 years old and ≤ 65 years old, male or female, subjects voluntarily participate in this clinical study and sign the Informed Consent Form (ICF);\n2. Diagnosis of immune thrombocytopenia (UTP) (according to American Society of Hematology 2019 guidelines and International ITP Working Group);\n3. Platelet count is decreased in routine blood tests at least two consecutive times, with no obvious abnormalities in the morphology of blood cells on microscopic examination of peripheral blood smears;\n4. Spleen is not enlarged during screening;\n5. The morphology of bone marrow cells in subjects is characterized by increased or normal megakaryocytes with impaired maturation;\n6. Exclude other secondary thrombocytopenia: secondary thrombocytopenia due to autoimmune diseases, thyroid disorders, lymphoproliferative disorders, myelodysplastic syndromes (MDS), aplastic anemia (AA), various malignant blood disorders, neoplastic infiltrates, chronic liver disease, hypersplenism, common variable immunodeficiency disease (CVID), infections, vaccinations, etc.; thrombocytopenia; drug-induced thrombocytopenia; homozygous thrombocytopenia; thrombocytopenia during pregnancy; congenital thrombocytopenia and pseudothrombocytopenia. Thrombocytopenia due to consumption; drug-induced thrombocytopenia; isoimmune thrombocytopenia; thrombocytopenia in pregnancy; congenital thrombocytopenia and pseudothrombocytopenia;\n7. Subjects with refractory ITP who are refractory to first-line therapeutic agents, thrombopoietic agents in second-line therapy, and rituximab, or who have had ineffective splenectomies\u002Fpostoperative recurrences, and who undergo diagnostic reassessment and remain diagnosed with ITP;\n8. Patients with refractory ITP: refractory to first-line therapeutic agents, thrombopoietic agents in second-line therapy, and rituximab; patients diagnosed with ITP despite unsuccessful splenectomy\u002Fpostoperative recurrence on diagnostic reassessment\n9. ECOG score ≤ 1;\n10. Left ventricular ejection fraction (LVEF) ≥50% and no clinically significant pericardial effusion;\n11. ≥ 4 weeks after subjects received last dose treatment (Radiotherapy, chemotherapy, monoclonal antibody therapy or other treatments);\n12. NRT, antimalarial monotherapy, antimalarials in combination with OCS and\u002For immunosuppressants, combination of OCS and\u002For immunosuppressants.\n\nExclusion Criteria:\n\n1. Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine, tozumabs), or subjects with a history of severe allergic reactions;\n2. Subjects with active infection receiving intravenous (IV) antibiotic treatment, or received intravenous (IV) antibiotic treatment within one week prior to anti-CD19 CAR NK Cell (KN5501) infusion;\n3. Subjects with acquired and congenital immunodeficiency diseases;\n4. Subjects with grade III or IV heart failure (NYHA classification);\n5. History of epilepsy or other central nervous system (CNS) diseases;\n6. History of severe herpes infections such as herpes encephalitis, ocular herpes, or diffuse herpes;\n7. History of other primary malignant tumors except:\n\n   a Cured non-melanoma skin cancer by surgical excision, for example basal cell carcinoma (BCC) ; b Cured primary malignant tumors, such as cervical cancer, superficial bladder cancer, breast cancer;\n8. Signs of herpes or varicella zoster virus infection (specifically varicella, zoster) within 12 weeks prior to screening; history of any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urinary, pulmonary, neurologic, dermatologic, psychiatric, and renal disease or other significant medical condition, other than lupus, that prevents administration of BIIB059 (as determined by the investigator)\n9. Females who are pregnant, lactating, or planning a pregnancy within six months;\n10. History or current diagnosis of clinically significant non-ITP-induced thrombocytopenia\n11. Subjects who have received other clinical trial treatment within 3 month;\n12. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome.","65 Years",{"count":87,"type":20},9,[89],"EARLY_PHASE1","A single arm, open-label pilot study is designed to determine the safety and effectiveness of CD19 CAR NK cells (KN5501) in patients with refractory immune thrombocytopenia. 9 patients are planned to be enrolled in the dose-escalation trial (9×10\\^9 cells, 13.5×10\\^9 cells). The primary objective of the study is to evaluation of the safety and feasibility of KN5501 for the treatment of relapsed\u002Frefractory B-cell related autoimmune diseases. The secondary objective is to evaluate evaluation of KN5501 for the treatment of refractory immune thrombocytopenia. The exploratory objective is to evaluate expansion, persistence and ability to deplete CD19 positive B cells of KN5501 in patients with refractory immune thrombocytopenia.",[92],"Thrombocytopenia Alloimmune","2025-04-26",{"date":95,"type":40},"2025-04-30",{"date":97,"type":40},"2024-08-30",{"date":99,"type":20},"2026-07-30",{"name":46,"class":47},{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":21,"phases":111,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":48},"100547218","phase-2-fmtsoxsintilimab-as-first-line-treatment-for-advanced-gastric-cancer-100547218","NCT06405113","FMT+SOX+Sintilimab As First-line Treatment for Advanced Gastric Cancer","Fecal Microbiota Transplantation Combined with SOX and Sintilimab As First-line Treatment for Advanced Gastric Cancer:A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study (FMT-JSNO-01)","Inclusion Criteria:\n\n* Subjects aged 18-80 (including 18 and 80 years old);\n* Understand the research steps and content, and voluntarily sign a written informed consent form;\n* Non resectable Her-2 negative advanced or metastatic gastric\u002Fgastroesophageal junction adenocarcinoma confirmed by histopathology and\u002For cytology, excluding all other histological types;\n* At least one measurable lesion, according to RECIST 1.1 standard;\n* Have not received anti-tumor treatment in the past;\n* The physical status score of Eastern Tumor Collaboration Group (ECOG) was 0-1;\n* Expected survival time ≥ 3 months;\n* Have adequate organ and bone marrow function, laboratory examination within 7 days prior to enrollment meets the following requirements (no blood components, cell growth factors, albumin or other corrective drugs are allowed within 14 days prior to obtaining laboratory examination), as follows: 1) Blood routine: absolute neutrophil count (ANC) ≥1.5×109\u002FL, platelet (PLT) ≥75×109\u002FL, hemoglobin (HGB) ≥90 g\u002FL (no blood transfusion or erythropoietin dependence within 14 days); 2) Liver function: serum total bilirubin (TBIL) ≤2 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) ≤ 5x ULN, serum albumin ≥28 g\u002FL; alkaline phosphatase (ALP) ≤5×ULN; 3) Renal function: serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance ≥50 mL\u002Fmin (using the standard Cockcroft-Gault formula) : Urine routine results showed urinary protein \\\u003C 2+; For patients with urine protein ≥2+ at baseline,24-hour urine collection and 24-hour urine protein quantification\\\u003C1g should be performed; 4) Coagulation function: International standardized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN; If the subject is receiving anticoagulant therapy, as long as the INR is within the intended range of anticoagulant drug use.\n* For female subjects of reproductive age, a urine or serum pregnancy test should be performed and the result is negative 3 days prior to receiving the initial study drug administration;\n* Subjects and their sexual partners are required to use a medically approved contraceptive method (such as an IUD, contraceptive pill, or condom) during the study treatment period and for 6 months after the end of the study treatment period.\n\nExclusion Criteria:\n\n* Currently participating in an interventional clinical study or receiving another investigational drug or investigational device within 4 weeks prior to initial dosing;\n* Received proprietary Chinese medicines with anti-tumor indications or immunomodulatory drugs (thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration, or received major surgical treatment within 3 weeks before the first administration;\n* Class III - IV congestive heart failure (New York Heart Association classification), poorly controlled and clinically significant arrhythmias;\n* Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, occurred within 6 months before treatment;\n* Known allergic reaction to the drug in this study;\n* Patients requiring long-term systemic use of corticosteroids. Patients with COPD or asthma requiring intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroids could be enrolled;\n* Symptomatic central nervous metastases. Patients with asymptomatic BMS or BMS whose symptoms are stable after treatment are eligible to participate in this study if they meet all of the following criteria: measurable lesions outside the central nervous system; No midbrain, pontine, cerebellum, meninges, medulla oblongata or spinal cord metastasis; Maintain clinical stability for at least 2 weeks;\n* Stop hormone therapy 3 days before the first dose of the study drug;\n* There is an active infection requiring treatment or systemic anti-infective drugs have been used in the week prior to the first dosing;\n* Has not fully recovered from toxicity and\u002For complications caused by any intervention before starting treatment (i.e., ≤ grade 1 or baseline, excluding weakness or hair loss);\n* Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1\u002F2 antibody positive);\n* Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected greater than the upper limit of normal value in the laboratory of the study center);\n* Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection);\n* Pregnant or lactating women;\n* Medical history or evidence of disease that may interfere with test results, prevent participants from fully participating in the study, abnormal treatment or laboratory test values, or other conditions that the investigator considers unsuitable for enrollment The Investigator considers other potential risks unsuitable for participation in the study.","80 Years",{"count":110,"type":20},198,[112],"PHASE2","the investigators plan to initiate a prospective, multicenter, randomized, double-blind, placebo-controlled phase II study, recruiting 198 patients with advanced gastric\u002Fgastroesophageal junction adenocarcinoma who have not received prior treatment. Randomly divided into two groups, one group is the group of fecal microbiota transplantation(FMT)+SOX+Sintilimab, and the other group is the group of SOX+Sintilimab. Compare the 2-year OS rates of the two groups to verify whether the addition of FMT to first-line treatment can improve the prognosis of gastric cancer patients.",[115],"Gastric Cancer","2025-02-17",{"date":118,"type":40},"2025-02-20",{"date":120,"type":40},"2024-06-01",{"date":122,"type":20},"2027-06-01",{"name":46,"class":47},{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":131,"sex":16,"minAge":17,"maxAge":108,"enrollmentInfo":132,"targetDuration":4,"studyType":21,"phases":134,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":142,"leadSponsor":144,"locationsCount":48},"100547064","phase-2-fmtimmunotherapychemotherapy-as-first-line-treatment-for-driver-gene-negative-advanced-nsclc-100547064","NCT06403111","FMT+Immunotherapy+Chemotherapy As First-line Treatment for Driver-gene Negative Advanced NSCLC","Fecal Microbiota Transplantation Combined with Platinum-based Doublet Chemotherapy and Tislelizumab As First-line Treatment for Driver-gene Negative Advanced Non-small-cell Lung Cancer (NSCLC): Study Protocol for a Prospective, Multi-center, Single-arm Exploratory Trial","Inclusion Criteria:\n\n1. The subjects voluntarily joined the study and were able to sign the informed consent with good compliance;\n2. Age 18-80 years old (when signing the informed consent form);\n3. Patients with histologically or cytologically proven locally advanced (stage IIIB\u002FIIIC), metastatic, or recurrent (stage IV) NSCLC who are inoperable and unable to receive radical concurrent chemoradiotherapy, according to the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification, 8th Edition TNM Classification of Lung cancer;\n4. Have not received systemic intravenous anti-tumor therapy before, and the driver gene is negative;\n5. PD-L1 expression \\\u003C 50%;\n6. According to the solid tumor efficacy evaluation criteria (RECIST version 1.1), there is at least one radiographically measurable lesion; That is, in CT or MRI detection, the longest diameter of a single lesion was ≥10mm, or the pathological enlargement of a single lymph node was ≥15mm.\n7. The physical status score of Eastern Tumor Collaboration Group (ECOG) was 0-1;\n8. Expected survival \\> 3 months;\n9. Have adequate organ and bone marrow function, laboratory examination within 7 days prior to enrollment meets the following requirements (no blood components, cell growth factors, albumin or other corrective drugs are allowed within 14 days prior to obtaining laboratory examination), as follows: 1) Blood routine: absolute neutrophil count (ANC) ≥1.5×10 9\u002FL, platelet (PLT) ≥75×10 9\u002FL, hemoglobin (HGB) ≥90 g\u002FL (no blood transfusion or erythropoietin dependence within 14 days); 2) Liver function: serum total bilirubin (TBIL) ≤2 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) ≤ 5x ULN, serum albumin ≥28 g\u002FL; alkaline phosphatase (ALP) ≤5×ULN; 3) Renal function: serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance ≥50 mL\u002Fmin (using the standard Cockcroft-Gault formula) : Urine routine results showed urinary protein \\\u003C 2+; For patients with urine protein ≥2+ at baseline, 24-hour urine collection and 24-hour urine protein quantification \\\u003C 1g should be performed. 4) Coagulation function: International standardized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN; If the subject is receiving anticoagulant therapy, as long as the INR is within the intended range of anticoagulant drug use.\n10. For female subjects of reproductive age, a urine or serum pregnancy test should be performed and the result is negative 3 days prior to receiving the initial study drug administration;\n11. Subjects and their sexual partners are required to use a medically approved contraceptive method (such as an intrauterine device (IUD), contraceptive pill, or condom) during the study treatment period and for 6 months after the end of the study treatment period.\n\nExclusion Criteria:\n\n1. Currently participating in an interventional clinical study or receiving another investigational drug or investigational device within 4 weeks prior to initial dosing;\n2. Received proprietary Chinese medicines with anti-tumor indications or immunomodulatory drugs (thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration, or received major surgical treatment within 3 weeks before the first administration;\n3. Class III - IV congestive heart failure (New York Heart Association classification), poorly controlled and clinically significant arrhythmias;\n4. Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, occurred within 6 months before treatment;\n5. Known allergic reaction to the drug in this study;\n6. Patients who require long-term oral, intravenous, or intramuscular administration of systemic corticosteroids;\n7. Symptomatic central nervous metastases. Patients with asymptomatic brain metastases (BMS) or BMS whose symptoms are stable after treatment are eligible to participate in this study if they meet all of the following criteria: measurable lesions outside the central nervous system; No midbrain, pontine, cerebellum, meninges, medulla oblongata or spinal cord metastasis; Maintain clinical stability for at least 2 weeks; Stop hormone therapy 3 days before the first dose of the study drug;\n8. There is an active infection requiring treatment or systemic anti-infective drugs have been used in the week prior to the first dosing;\n9. Has not fully recovered from toxicity and\u002For complications caused by any intervention before starting treatment (i.e., ≤ grade 1 or baseline, excluding weakness or hair loss);\n10. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1\u002F2 antibody positive);\n11. Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected greater than the upper limit of normal value in the laboratory of the study center);\n12. Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection);\n13. Received live vaccine within 30 days prior to the first dose (cycle 1, day 1); Note: Injectable inactivated virus vaccine against seasonal influenza is permitted for 30 days prior to initial administration; However, live attenuated influenza vaccines administered intranasally are not permitted.\n14. Pregnant or lactating women;\n15. Medical history or evidence of disease that may interfere with test results, prevent participants from fully participating in the study, abnormal treatment or laboratory test values, or other conditions that the investigator considers unsuitable for enrollment The Investigator considers other potential risks unsuitable for participation in the study.",true,{"count":133,"type":20},62,[112],"This study plans to reconstruct intestinal microecology through fecal microbiota transplantation (FMT), and combine with standard first-line therapy to enhance the anti-tumor immune effect at the same time, thereby extending the progression-free survival of patients and improving the prognosis of patients.",[137],"Non-small Cell Lung Cancer","2024-12-18",{"date":140,"type":40},"2024-12-20",{"date":120,"type":40},{"date":143,"type":20},"2026-06-01",{"name":46,"class":47},{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":131,"sex":16,"minAge":17,"maxAge":108,"enrollmentInfo":152,"targetDuration":4,"studyType":21,"phases":153,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":163,"locationsCount":48},"100547154","phase-1--t-pd-1-ab-cells-in-the-treatment-of-advanced-solid-tumors-100547154","NCT06404281","γδ T-PD-1 Ab Cells in the Treatment of Advanced Solid Tumors","Anti-PD-1 Antibody Armored γδ T Cells in the Treatment of Advanced Solid Tumors, a Phase I Clinical Trail","Inclusion Criteria:\n\n1. The patient voluntarily signs the informed consent and can complete the follow-up examination, evaluation and treatment;\n2. Age 18-80 years old, gender is not limited;\n3. The histopathological diagnosis was malignant solid tumor;\n4. Clinical or pathological was stage IV according to AJCC 8th edition stage;\n5. Subjects with advanced solid tumors without standard treatment options;\n6. ECOG score 0-1;\n7. Expected survival ≥6 months;\n8. Have at least one evaluable lesion according to RECIST 1.1 criteria;\n9. Organ function level requirements (no blood transfusion or blood products, no hematopoietic stimulating factors, no albumin or blood products used within 14 days prior to the first dose);\n10. Bone marrow function: absolute value of neutrophils (ANC) ≥1.5×109, platelets ≥75×109, and hemoglobin (Hb) ≥90g\u002FL;\n11. Liver function: total bilirubin ≤1.5 times the upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times ULN (5.0 times ULN if liver metastasis is present), alkaline phosphatase \\\u003C 5 × ULN;\n12. Renal function: serum creatinine level ≤2 ULN, creatinine clearance \\> 50mL\u002Fmin (according to Cockcroft-Gault formula); Urine protein \\\u003C2+(If urine protein ≥2+, urine protein measurement should be collected for 24 hours, and the total amount should be \\\u003C1g to be allowed to enter the group);\n13. The serum pregnancy test of women of childbearing age in the 7 days prior to Gamma-delta T-PD-1 Ab infusion is negative, and any fertile male and female subject must consent to the use of an effective contraceptive method throughout the study and for at least 12 weeks after the last study administration. In the researchers' judgment, a subject is fertile: he\u002Fshe is biologically capable of having children and having a normal sex life.\n14. A hysterectomy or bilateral oophorectomy has been performed, or ovarian failure has been medically confirmed, or post-menopause has been medically confirmed (menopause for at least 12 consecutive months without pathological or physiological causes).\n\nExclusion Criteria:\n\n1. Intolerance or allergy to any ingredient or similar drug in the treatment plan planned for this study;\n2. Metastasis of symptomatic central system;\n3. Have received other cell therapies, including NK, CIK, DC, CTL, CAR-T, TCR-T, and stem cell therapy in the past 4 weeks;\n4. Received systemic steroid therapy (\\> 10 mg\u002Fkg prednisone or equivalent) or any other form of immunosuppressive medication within two weeks prior to the first dose; Corticosteroids (≤10mg oral prednisone or equivalent) were used in subjects with chronic obstructive pulmonary disease, saline corticosteroids (such as hydrohydrocortisone) were used in subjects with postural hypotension, and low-dose supplemental corticosteroids were used in subjects with adrenal insufficiency.\n5. Plan to use any other form of systemic antitumor therapy during the study period;\n6. History of known hematological malignancy, primary brain tumor or sarcoma, or other primary solid tumor within 6.5 years, unless cured and no evidence of recurrence of the disease within 5 years. With the exception of cured basal cell carcinoma of the skin and cervical carcinoma in situ;\n7. History of interstitial lung disease, non-infectious pneumonia or uncontrolled disease, including pulmonary fibrosis and acute lung disease;\n8. Active autoimmune diseases within the past 2 years requiring systemic treatment (such as glucocorticoids or immunosuppressive drugs), and related replacement therapy (such as thyroxine, insulin, or physiologic glucocorticoid replacement therapy for renal or pituitary insufficiency); Bisphosphonates were administered within 2 months prior to Γδ T-PD-1 Ab infusion.\n9. Known subjects had systemic vasculitis, co-active or uncontrolled autoimmune disease, primary or secondary immune deficiency, graft-versus-host disease (GvHD).\n10. Hepatitis B infection, hepatitis C infection, human immunodeficiency virus (HIV) infection, Treponema pallidum (TP) infection.\n11. Had undergone major surgery within 4 weeks prior to screening that was assessed by the investigator as unsuitable for enrollment.\n12. Acute infection and gastrointestinal bleeding occurred in 4 weeks.\n13. Major organ dysfunction: absolute value of neutrophils (ANC) \\\u003C 1.5×109, platelets \\\u003C 75×109, and hemoglobin (Hb) \\\u003C 90g\u002FL; Serum albumin \\\u003C 28g\u002FL, total bilirubin \\>51μmol\u002FL, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>5 times the upper limit of normal, creatinine \\> 1.5 times the upper limit of normal; Have abnormal coagulation function (INR \\> 1.5 or PT \\>1.2 ULN or PTT \\>1.2 ULN), have a tendency to bleed, or are receiving thrombolytic or anticoagulant therapy.\n14. The subject's heart meets any of the following conditions: Left ventricular ejection fraction (LVEF) ≤45%; New York Heart Association (NYHA) Class III or IV congestive heart failure; QTcB \\> 450 msec; Other heart conditions that the investigators judged unsuitable for inclusion.\n15. People with a history of epilepsy or other active central nervous system diseases.\n16. Received live vaccine within 6 weeks prior to screening, and received hematopoietic stimulating factors, such as colony-stimulating factor and erythropoietin, within 2 weeks prior to treatment; Major surgical procedures (excluding diagnostic surgical procedures) within 4 weeks before the start of treatment;\n17. Evidence of uncontrolled and severe active infection at the time of screening (e.g., sepsis, bacteremia, fungemia), or a recent (within 4 months) history of deep tissue infection (e.g., fasciitis or osteomyelitis).\n18. Participate in other interventional clinical investigators within 3 months prior to infusion of γδ T-PD-1 AB-PD-1 Ab.\n19. A known mental or substance abuse disorder may interfere with the requirement to cooperate in the completion of the trial.\n20. Women who are pregnant or breastfeeding, or who plan to become pregnant or have children during the study period.\n21. In the investigator's judgment, the subject has any serious acute or chronic physical or mental illness, or laboratory abnormalities that could increase the risk of study participation, study administration, or possibly affect the interpretation of study results.",{"count":87,"type":20},[23],"This study intends to combine the advantages of γδ T cells and PD-1 monoclonal antibody to conduct an exploratory clinical study on the safety and efficacy of PD-1 antibody armored γδ T cells (γδ T-PD-1 Ab cells) in the treatment of advanced solid tumors.",[156],"Advanced Solid Tumor","2024-08-20",{"date":159,"type":40},"2024-08-22",{"date":161,"type":40},"2024-08-01",{"date":143,"type":20},{"name":46,"class":47},""]