[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630714":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":28,"centralContacts":35,"locations":41,"responsibleParty":57,"collaborators":28,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":28,"eligibilityCriteria":66,"healthyVolunteers":63,"sex":67,"minAge":68,"maxAge":28,"enrollmentInfo":69,"targetDuration":28,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":82,"whyStopped":28,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Fujian Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with relapsed\u002Frefractory CD19-positive acute B-lymphoblastic leukemia","EXPERIMENTAL","A conditional chemotherapy regimen of fludarabine and cyclophosphamide will be administered, followed by investigational therapy, QH103 Cells\n\nInterventions:\n\nBiological: QH103 Cell Injection Drug: Fludarabine Drug: Cyclophosphamide",[13,14,15],"Drug: Cyclophosphamide","Drug: Fludarabine","Biological: QH103 Cell Injection",[17,24,29],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Cyclophosphamide","Eligible subjects will undergo lymphodepletion chemotherapy 5 to 3 days prior to cell infusion. The recommended lymphodepletion regimen comprises cyclophosphamide (500-1000 mg\u002Fm² administered 3 days).",[9],[23],"CD19CAR-γδT cell injection",{"type":18,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"Fludarabine","Eligible subjects will receive lymphodepletion chemotherapy 5 to 3 days prior to cell infusion. The recommended lymphodepletion regimen comprises fludarabine (30-40 mg\u002Fm² administered 3 days).",[9],null,{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"BIOLOGICAL","QH103 Cell Injection","Biological: CD19 CAR-γδT cell Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with dose escalation (3+3) : dose 1 (1×10\\^8 CAR+cells) ,dose 2 (3× 10\\^8 CAR+cells).",[9],[23],[36],{"name":37,"role":38,"phone":39,"phoneExt":28,"email":40},"Ting Yang","CONTACT","+86 13950210357","yang.hopeting@gmail.com",[42],{"facility":43,"status":28,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"The first affiliated hospital of fujian medical university","Fuzhou","Fujian","350005","China","CN",{"type":50,"coordinates":51},"Point",[52,53],119.30611,26.06139,{"lat":53,"lon":52},[56],{"name":37,"role":38,"phone":39,"phoneExt":28,"email":40},{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","Ting YANG","Director of Second Hematology Department and Hematopoietic Stem Cell Transplantation Center","100630714","phase-1-clinical-study-of-universal-cd19-car--t-cell-infusion-in-the-treatment-of-relapsedrefractory-acute-b-lymphoblastic-leukemia-100630714",false,"NCT07491263","Clinical Study of Universal CD19 CAR-γδ T Cell Infusion in the Treatment of Relapsed\u002FRefractory Acute B Lymphoblastic Leukemia","Inclusion Criteria:\n\n* Age \\> 14 years, gender unrestricted;\n* Clinically diagnosed with relapsed\u002Frefractory acute B-lymphoblastic leukemia, with bone marrow blast\u002Fimmature lymphocyte proportion ≥5% (morphology) (excluding cases with isolated extramedullary involvement), meeting any of the following criteria:\n\n  1. Failure to achieve CR after 2 cycles of standard chemotherapy;\n  2. Initial induction achieved CR, but CR duration ≤12 months;\n  3. Relapsed\u002Frefractory B-ALL refractory to first or multiple salvage therapies;\n  4. Post-hematopoietic stem cell transplantation relapse, including hematological relapse and minimal residual disease (MRD) positivity;\n  5. Patients for whom no standard therapy exists.\n* Cytology or histology confirms tumor cell immunophenotype as CD19-positive;\n* Expected survival time exceeding 3 months;\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;\n* Key organ functions meeting the following criteria: left ventricular ejection fraction ≥50% by echocardiography; serum creatinine ≤1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN; total bilirubin ≤1.5 × ULN;\n* Negative pregnancy test for women of childbearing potential; both males and females agree to use effective contraception during treatment and for 1 year thereafter;\n* Toxicity from prior anti-tumor therapy ≤ Grade 1 (according to CTCAE v5.0) or at an acceptable level per inclusion\u002Fexclusion criteria;\n* No significant hereditary diseases;\n* Able to comprehend the trial requirements and procedures, and willing to participate in the clinical study as required;\n* Signed informed consent form for the trial\n\nExclusion Criteria:\n\n* Presence of central nervous system (CNS) involvement or a clinically significant history of CNS diseases, such as epilepsy and cerebrovascular diseases;\n* Pregnant or lactating women, or women who disagree to use effective contraception during treatment and within 1 year after treatment;\n* Other malignancies that are not in remission;\n* Patients with primary immunodeficiency or autoimmune diseases requiring immunosuppressive therapy;\n* Patients who have received allogeneic immune cell therapy within 6 months before enrollment, or donor lymphocyte infusion within 6 weeks before enrollment;\n* Confirmed positive anti-FMC63 and DSA responses in the patient's serum;\n* Patients who have participated in other clinical trials within 4 weeks before enrollment;\n* Uncontrolled infectious diseases or other serious conditions, including but not limited to infections (human immunodeficiency virus, acute or chronic active hepatitis B or C), congestive heart failure, unstable angina, arrhythmia, or conditions considered by the treating physician to pose unpredictable risks;\n* History of stroke or intracranial hemorrhage within 3 months before enrollment;\n* Major surgery or trauma within 28 days before enrollment, or main side effects not yet recovered;\n* History of allergy to any component of the cell product;\n* Inability to understand or unwillingness to sign the informed consent form;\n* Other reasons deemed by the researchers as unsuitable for the clinical trial.","ALL","14 Years",{"count":70,"type":71},6,"ESTIMATED","INTERVENTIONAL",[74],"PHASE1","This study is an open-label, single-arm clinical trial designed to evaluate the safety and tolerability of QH103 cell infusion in subjects with CD19-positive R\u002FR B-ALL.",[77],"Relapsed\u002FRefractory CD19-positive B-ALL",[79,80,81],"CD19","CAR-γδT","cell therapy","NOT_YET_RECRUITING","2026-03-18",{"date":85,"type":86},"2026-03-24","ACTUAL",{"date":88,"type":71},"2026-05-01",{"date":90,"type":71},"2028-12-31",{"name":5,"class":6},1]