[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100487385":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":24,"studyPopulation":17,"armGroups":25,"interventions":32,"overallOfficials":17,"centralContacts":37,"locations":47,"responsibleParty":64,"collaborators":17,"id":66,"slug":17,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":17,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":17,"studyType":78,"phases":79,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":50,"whyStopped":17,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Hebei Senlang Biotechnology Inc., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":17},[9,13],{"measure":10,"description":11,"timeFrame":12},"Safety: Incidence and severity of adverse events","To evaluate the possible adverse events occurred within first one month after CD7 CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity","First 1 month post CAR-T cells infusion",{"measure":14,"description":15,"timeFrame":16},"Remission Rate","To obsere the efficacy of CAR-T cells after infusion, complete remission (CR), complete remission with incomplete recovery of blood cells (CRi), minimal tumor residual positive(MRD+) or negative (MRD-) CR\u002FCRi, disease recurrence or progression (PD) will be used for evaluation.","3 months post CAR-T cells infusion",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"NA","SINGLE_GROUP","TREATMENT",{"masking":23,"maskingDescription":17,"whoMasked":17},"NONE","The CARs consist of an anti-CD7 single-chain variable fragment（scFv）, a portion of the human CD137（4-1BB） molecule, and the intracellular component of the human CD3ζ molecule. Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.",[26],{"label":27,"type":28,"description":29,"interventionNames":30},"CD-7 CART","EXPERIMENTAL","Patients will be treated with CD7 CAR-T cells",[31],"Biological: Senl-T7",[33],{"type":34,"name":35,"description":29,"armGroupLabels":36,"otherNames":17},"BIOLOGICAL","Senl-T7",[27],[38,43],{"name":39,"role":40,"phone":41,"phoneExt":17,"email":42},"Xian Zhang","CONTACT","008618611636172","xian_zhang@126.com",{"name":44,"role":40,"phone":45,"phoneExt":17,"email":46},"Jianqiang Li, MD, PhD","008615511369555","limmune@gmail.com",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":17,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Hebei yanda Hospital","RECRUITING","Beijingcun","Hebei","China","CN",{"type":56,"coordinates":57},"Point",[58,59],119.10946,41.26103,{"lat":59,"lon":58},[62],{"name":63,"role":40,"phone":17,"phoneExt":17,"email":42},"xian zhang",{"type":65,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","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":76,"type":77},100,"ESTIMATED","INTERVENTIONAL",[19],"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.",[82],"T-cell Acute Lymphoblastic Leukemia\u002FLymphoma",[84,85,86,87],"T-ALL","T-LBL","CD7","CAR-T","2022-11-22",{"date":90,"type":91},"2022-11-25","ACTUAL",{"date":93,"type":91},"2022-08-29",{"date":95,"type":77},"2027-12-30",{"name":5,"class":6},1]