[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100487385":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":30,"responsibleParty":47,"collaborators":19,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":19,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":19,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":33,"whyStopped":19,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Hebei Senlang Biotechnology Inc., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CD-7 CART","EXPERIMENTAL","Patients will be treated with CD7 CAR-T cells",[13],"Biological: Senl-T7",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","Senl-T7",[9],null,[21,26],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Xian Zhang","CONTACT","008618611636172","xian_zhang@126.com",{"name":27,"role":23,"phone":28,"phoneExt":19,"email":29},"Jianqiang Li, MD, PhD","008615511369555","limmune@gmail.com",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":19,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Hebei yanda Hospital","RECRUITING","Beijingcun","Hebei","China","CN",{"type":39,"coordinates":40},"Point",[41,42],119.10946,41.26103,{"lat":42,"lon":41},[45],{"name":46,"role":23,"phone":19,"phoneExt":19,"email":25},"xian zhang",{"type":48,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100487385","clinical-study-of-senl-t7-car-t-cells-in-the-treatment-of-relapsed-and-refractory-cd7-acute-t-allt-lbl-100487385",false,"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.","ALL","2 Years","70 Years",{"count":60,"type":61},100,"ESTIMATED","INTERVENTIONAL",[64],"NA","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.",[67],"T-cell Acute Lymphoblastic Leukemia\u002FLymphoma",[69,70,71,72],"T-ALL","T-LBL","CD7","CAR-T","2022-11-22",{"date":75,"type":76},"2022-11-25","ACTUAL",{"date":78,"type":76},"2022-08-29",{"date":80,"type":61},"2027-12-30",{"name":5,"class":6},1]