[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100460601":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":44,"collaborators":11,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":11,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":11,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":29,"whyStopped":11,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Shenzhen Geno-Immune Medical Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CART\u002FCTL\u002FDCvac cells to treat T-ALL","EXPERIMENTAL",null,[13],"Biological: Antigen-specific T cells CAR-T\u002FCTL and DCvac",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"BIOLOGICAL","Antigen-specific T cells CAR-T\u002FCTL and DCvac","Antigen-specific T cells CAR-T\u002FCTL and DCvac cells to treat T-ALL",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Lung-Ji Chang, Ph.D","CONTACT","+86 0755-86573763","c@szgimi.org",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Shenzhen Geno-immune Medical Institute","RECRUITING","Shenzhen","Guangdong","518000","China","CN",{"type":36,"coordinates":37},"Point",[38,39],114.0683,22.54554,{"lat":39,"lon":38},[42],{"name":43,"role":23,"phone":24,"phoneExt":11,"email":25},"Lung-Ji Chang, ph.D",{"type":45,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100460601","phase-1-ngs-mrd-assessment-of-combination-immunotherapies-targeting-t-all-100460601",false,"NCT05277753","NGS-MRD Assessment of Combination Immunotherapies Targeting T-ALL","NGS-MRD Evaluation of Antigen-specific T Cells and DC Vaccine Combination Targeting T-cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Age older than 6 months.\n2. High-burden (≥ 30% blast cells) bone marrow sample for NGS TCR clonal identification and CTL\u002FDC vac preparation is required\n3. Expression of CD7, CD5, CD317, CD47, CD99, CD38 or TRBC1\u002F2 is determined in malignant cells by flow cytometry or immuno-histochemical staining.\n4. Karnofsky performance status (KPS) score is higher than 80 and life expectancy \\> 3 months.\n5. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5x upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3x upper limit of normal, total bilirubin ≤ 2.0 mg\u002FdL.\n6. Hgb ≥ 80g\u002FL.\n7. No cell separation contraindications.\n8. Abilities to understand and the willingness to provide written informed consent.\n\nExclusion Criteria:\n\n1. Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection.\n2. Active bacterial, fungal or viral infection not controlled by adequate treatment.\n3. Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n4. Pregnant or nursing women may not participate.\n5. History of glucocorticoid for systemic therapy within the week prior to entering the test.\n6. Previous treatment with any gene therapy products.\n7. Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.","ALL","6 Months","65 Years",{"count":57,"type":58},10,"ESTIMATED","INTERVENTIONAL",[61],"PHASE1","The purpose of this study is to determine the feasibility, safety, and efficacy of a combination therapy in the treatment of T-cell acute lymphoblastic leukemia (T-ALL): multi-antigen-targeted chimeric antigen receptor T cells (CAR-T) followed by engineered immune effector cytotoxic T cells (CTLs) and immune modified dendritic cell vaccine (DCvac). This approach is aimed to achieve NGS MRD negativity in T-ALL patients, which can identify a very low risk of relapse and define patients with possible long-term remission without further treatment.",[64],"T-Cell Acute Lymphoblastic Leukemia",[66,67,68,69],"T-ALL","CAR T","CTL","DC vaccine","2026-06-18",{"date":72,"type":73},"2026-06-23","ACTUAL",{"date":75,"type":73},"2026-06-01",{"date":77,"type":58},"2030-12-31",{"name":5,"class":6},1]