[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsedrefractory-cd19-positive-b-all\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsedrefractory-cd19-positive-b-all":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"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":18,"type":19},6,"ESTIMATED","INTERVENTIONAL",[22],"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.",[25],"Relapsed\u002FRefractory CD19-positive B-ALL",[27,28,29],"CD19","CAR-γδT","cell therapy","NOT_YET_RECRUITING","2026-03-18",{"date":33,"type":34},"2026-03-24","ACTUAL",{"date":36,"type":19},"2026-05-01",{"date":38,"type":19},"2028-12-31",{"name":40,"class":41},"Fujian Medical University","OTHER"]