[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630714":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":11,"studyPopulation":11,"armGroups":30,"interventions":39,"overallOfficials":11,"centralContacts":57,"locations":63,"responsibleParty":79,"collaborators":11,"id":83,"slug":11,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":11,"eligibilityCriteria":87,"healthyVolunteers":84,"sex":88,"minAge":89,"maxAge":11,"enrollmentInfo":90,"targetDuration":11,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":103,"whyStopped":11,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Fujian Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Adverse Event",null,"12 months",{"measure":14,"description":15,"timeFrame":16},"Incidence of Dose-Limiting Toxicities (DLTs)","DLT was defined as QH103 Cells-related events with onset within first 28 days following infusion.","28 days",[18,20,22],{"measure":19,"description":11,"timeFrame":12},"PK(Pharmacokinetics):Number and Copy Number of CD19 CAR-γδT cells",{"measure":21,"description":11,"timeFrame":12},"PK: Persistence of CD19 CAR-γδT",{"measure":23,"description":11,"timeFrame":12},"PD(Pharmacodynamics) ：Changes in Various Cytokine Levels (IL-2, IL-4, IL-6, IFN-γ, TNF α, etc.) from Baseline",{"allocation":25,"interventionModel":26,"interventionModelDescription":11,"primaryPurpose":27,"observationalModel":11,"timePerspective":11,"maskingInfo":28},"NA","SINGLE_GROUP","TREATMENT",{"masking":29,"maskingDescription":11,"whoMasked":11},"NONE",[31],{"label":32,"type":33,"description":34,"interventionNames":35},"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",[36,37,38],"Drug: Cyclophosphamide","Drug: Fludarabine","Biological: QH103 Cell Injection",[40,47,51],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"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).",[32],[46],"CD19CAR-γδT cell injection",{"type":41,"name":48,"description":49,"armGroupLabels":50,"otherNames":11},"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).",[32],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"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).",[32],[46],[58],{"name":59,"role":60,"phone":61,"phoneExt":11,"email":62},"Ting Yang","CONTACT","+86 13950210357","yang.hopeting@gmail.com",[64],{"facility":65,"status":11,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"The first affiliated hospital of fujian medical university","Fuzhou","Fujian","350005","China","CN",{"type":72,"coordinates":73},"Point",[74,75],119.30611,26.06139,{"lat":75,"lon":74},[78],{"name":59,"role":60,"phone":61,"phoneExt":11,"email":62},{"type":80,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Ting YANG","Director of Second Hematology Department and Hematopoietic Stem Cell Transplantation Center","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":91,"type":92},6,"ESTIMATED","INTERVENTIONAL",[95],"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.",[98],"Relapsed\u002FRefractory CD19-positive B-ALL",[100,101,102],"CD19","CAR-γδT","cell therapy","NOT_YET_RECRUITING","2026-03-18",{"date":106,"type":107},"2026-03-24","ACTUAL",{"date":109,"type":92},"2026-05-01",{"date":111,"type":92},"2028-12-31",{"name":5,"class":6},1]