[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100493027":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":48,"centralContacts":57,"locations":66,"responsibleParty":87,"collaborators":90,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":27,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":27,"studyType":106,"phases":107,"briefSummary":110,"conditions":111,"keywords":27,"overallStatus":69,"whyStopped":27,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Chinese PLA General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"MSC-IFNα monotherapy","EXPERIMENTAL","Subjects will be enrolled for safety evaluation of MSC-IFNα monotherapy. Subjects will receive MSC-IFNα infusion from a dose of 2×10\\^6 cells\u002Fkg 1-4 times every 4-6 weeks. All treatment-related adverse events(TRAE) will be recorded for at least 28 days after the cell infusion.",[13],"Biological: MSC-IFNα",{"label":15,"type":10,"description":16,"interventionNames":17},"MSC-IFNα combined with immunochemotherapy","Subjects will be enrolled and received MSC-IFNα combined with immunochemotherapy, namely nab-paclitaxel (125 mg\u002Fm2, 5 days before infusion), cyclophosphamide (200 mg\u002Fm2,4 days before infusion) and anti-PD-1 antibody (200mg, 7 days after infusion) for 4 cycles.\n\nFrom the 5th cycle, subjects will receive MSC-IFNα combined with anti-PD-1 antibody every 4-6 weeks for another 4 cycles for efficacy consolation. From the 9th cycle, subjects will receive anti-PD-1 antibody alone every 3 weeks for another 4 cycles for efficacy maintenance.",[13,18,19,20],"Drug: Nab paclitaxel","Drug: Cyclophosphamide","Drug: Anti-PD-1 monoclonal antibody",[22,28,35,39],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"BIOLOGICAL","MSC-IFNα","MSC-IFNα form a dose of 2×10\\^6 cells\u002Fkg, intravenous infusion every 4-6 weeks",[15,9],null,{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Nab paclitaxel","125mg\u002Fm2, intravenous infusion every 4-6 weeks",[15],[34],"Abraxane",{"type":29,"name":36,"description":37,"armGroupLabels":38,"otherNames":27},"Cyclophosphamide","200mg\u002Fm2, intravenous infusion every 4-6 weeks",[15],{"type":29,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Anti-PD-1 monoclonal antibody","200mg, intravenous infusion every 4-6 weeks",[15],[44,45,46,47],"Toripalimab Injection","Sintilimab Injection","Camrelizumab Injection","Tislelizumab Injection",[49,53],{"name":50,"affiliation":51,"role":52},"WeiDong Han, PhD","Chinsese PLA Gereral Hospital","PRINCIPAL_INVESTIGATOR",{"name":54,"affiliation":55,"role":56},"Yufang Shi, PhD","Wuxi Sinotide New Drug Discovery Institutes","STUDY_CHAIR",[58,62],{"name":50,"role":59,"phone":60,"phoneExt":27,"email":61},"CONTACT","010-66937231","hanwdrsw@sina.com",{"name":63,"role":59,"phone":64,"phoneExt":27,"email":65},"Guanghua Rong, PhD","010-66947473","guanghua.rong@gmail.com",[67],{"facility":68,"status":69,"city":70,"state":27,"zip":27,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Department of Biotherapeutic, Chinese PLA General Hospital","RECRUITING","Beijing","China","CN",{"type":74,"coordinates":75},"Point",[76,77],116.39723,39.9075,{"lat":77,"lon":76},[80,84],{"name":81,"role":59,"phone":82,"phoneExt":27,"email":83},"WeiDong Han, Ph.D","+86-10-66937463","hanwdrsw@163.com",{"name":85,"role":59,"phone":86,"phoneExt":27,"email":65},"GuangHua Rong, Ph.D","+86-10-66947473",{"type":52,"investigatorFullName":88,"investigatorTitle":89,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Han weidong","Director of Biotherapeutic Department",[91],{"name":55,"class":92},"UNKNOWN","100493027","phase-1-ifn-expressing-mesenchymal-stromal-cells-for-locally-advancedmetastatic-solid-tumors-100493027",false,"NCT05699811","IFNα Expressing Mesenchymal Stromal Cells for Locally Advanced\u002FMetastatic Solid Tumors","Phase I\u002FII Trial of Allograft Engineered MSC-IFNα Combined With or Without Immunochemotherapy for Locally Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n1. Age from 18 to 75 years with estimated life expectancy \\>3 months.\n2. Histopathological confirmed locally advanced or metastatic solid tumors including, but not limited to, lung cancer, breast cancer, colorectal cancer, hepatocellular carcinoma, and sarcomas.\n3. Failed to at least first-line and second-line treatments or initially diagnosed locally advanced\u002Fmetastatic solid tumors that have no National Comprehensive Cancer Network(NCCN) guideline-recommended therapy.\n4. Have at least one measurable target lesion.\n5. Previous treatment must be completed for more than 4 weeks prior to the enrollment of this study.\n6. Have an Eastern Cooperative Oncology Group performance status (ECOG) of 0 to 2 at the time of enrollment.\n7. Have adequate organ function, which should be confirmed within 2 weeks prior to the first dose of study drugs.\n8. Previous treatment with anti-PD-1\u002FPD-L1 antibodies is allowed.\n9. Ability to understand and sign a written informed consent document.\n10. Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and up to 90 days after the last dose of the drug.\n\nExclusion Criteria:\n\n1. Active, known, or suspected autoimmune diseases.\n2. Known brain metastases or active central nervous system (CNS). Subjects with CNS metastases who were treated with radiotherapy for at least 3 months prior to enrollment, have no central nervous symptoms, and are off corticosteroids, are eligible for enrollment, but require a brain MRI screening.\n3. Subjects are being treated with either corticosteroid (\\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment.\n4. History of psychiatric disorders including depression, suicidality, and mania.\n5. History of allergy or intolerance to study drug components.\n6. Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.\n7. Uncontrolled concurrent illness, including ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (excluding insignificant sinus bradycardia and sinus tachycardia), or psychiatric illness\u002Fsocial situations and any other illness that would limit compliance with study requirements and jeopardize the safety of the patient.\n8. History of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).\n9. Pregnant or breast-feeding. Women of childbearing potential must have a pregnancy test performed within 7 days before enrollment, and a negative result must be documented.\n10. Previous or concurrent cancer within 3 years prior to treatment start.","ALL","18 Years","75 Years",{"count":104,"type":105},40,"ESTIMATED","INTERVENTIONAL",[108,109],"PHASE1","PHASE2","The goal of this first-in-human, single-center, prospective, open-label, phase 1\u002F2 trial is to evaluate the safety and efficacy of the interferon alpha expressing mesenchymal stromal cells (MSC-IFNα) combined with or without immunochemotherapy in patients with locally advanced\u002Fmetastatic solid tumors. The main questions aimed to answer are 1) to evaluate the safety and feasibility of MSC-IFNα in the treatment of locally advanced\u002Fmetastatic solid tumors;2) to evaluate the anti-tumor effects of the MSC-IFNα combined with or without immunochemotherapy in the treatment of locally advanced\u002Fmetastatic solid tumors; 3) to evaluate the pharmacokinetics\u002Fpharmacodynamics of MSC-IFNα and related immune effector cells.",[112],"Locally Advanced or Metastatic Solid Tumors","2023-04-27",{"date":115,"type":116},"2023-04-28","ACTUAL",{"date":118,"type":116},"2023-02-23",{"date":120,"type":105},"2026-12-31",{"name":5,"class":6},1]