[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621395":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":47,"collaborators":51,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":20,"studyType":69,"phases":70,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":77,"whyStopped":20,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Xuzhou Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CAR-T","EXPERIMENTAL","This arm of the study involves the administration of anti-CLL1-CD33-NKG2D Bicephali CAR-T cells to patients with relapsed\u002Frefractory acute myeloid leukemia (AML). Patients will undergo apheresis to collect their T cells, which will then be genetically modified in the laboratory to express the anti-CLL1, CD33, and NKG2D receptors. The modified CAR-T cells will be reinfused into the patient to target and eliminate AML cells. This experimental treatment aims to evaluate the safety, efficacy, and immune response associated with this novel CAR-T therapy.\n\nKey endpoints include overall survival, progression-free survival, and response rates (such as complete remission or partial remission). Participants will be closely monitored for potential side effects, including cytokine release syndrome (CRS) and neurological toxicity, which are known risks of CAR-T cell therapy.",[13],"Biological: CAR-T",[15],{"type":16,"name":9,"description":11,"armGroupLabels":17,"otherNames":18},"BIOLOGICAL",[9],[19],"anti-CLL1-CD33-NKG2D Bicephali CAR-T cells",null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Kailin Xu, PhD","CONTACT","15162166166","lihmd@163.com",[28],{"facility":29,"status":20,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"The Affiliated Hospital oh Xuzhou Medical University","Xuzhou","Jiangsu","221006","China","CN",{"type":36,"coordinates":37},"Point",[38,39],117.28386,34.20442,{"lat":39,"lon":38},[42,43],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"name":44,"role":24,"phone":45,"phoneExt":20,"email":46},"Qian Sun, Dr.","15949043172","sunqian3172@163.com",{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Kai Lin Xu，MD","Principal Investigator",[52],{"name":53,"class":54},"Yake Biotechnology Ltd.","INDUSTRY","100621395","phase-1-clinical-study-of-anti-cll1-cd33-nkg2d-bicephali-car-t-for-relapsedrefractory-acute-myeloid-leukemia-100621395",false,"NCT07370064","Clinical Study of Anti-CLL1-CD33-NKG2D Bicephali CAR-T for Relapsed\u002FRefractory Acute Myeloid Leukemia","A Phase I\u002FII Study to Evaluate the Safety and Efficacy of Anti-CLL1-CD33-NKG2D Bicephali CAR-T Cells in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","AML CAR-T","Inclusion Criteria:\n\nAge: Patients must be ≥18 years old. Diagnosis: Confirmed diagnosis of relapsed or refractory acute myeloid leukemia (AML) as per the World Health Organization (WHO) criteria.\n\nPrior Treatment: Must have failed at least one prior line of chemotherapy or targeted therapy.\n\nPerformance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n\nAdequate Organ Function:\n\nHematologic function: Absolute neutrophil count (ANC) ≥ 1,000\u002FμL, platelet count ≥ 50,000\u002FμL, and hemoglobin ≥ 8 g\u002FdL (without transfusion support).\n\nRenal function: Serum creatinine ≤ 1.5 x upper limit of normal (ULN). Liver function: Total bilirubin ≤ 2 x ULN, AST\u002FALT ≤ 2.5 x ULN. Informed Consent: The patient must be willing and able to provide written informed consent to participate in the study.\n\nEligible for Apheresis: Patients must be able to undergo the apheresis procedure to collect T cells for CAR-T cell modification.\n\nExclusion Criteria:\n\nActive Central Nervous System (CNS) Leukemia: Presence of active leukemia in the CNS.\n\nPregnancy or Breastfeeding: Female patients who are pregnant or breastfeeding. Severe Active Infections: Active and uncontrolled infections, including HIV, hepatitis B or C, or any other severe systemic infections.\n\nOther Malignancies: History of another malignancy (except for treated, localized cancers such as basal cell carcinoma) within the past 5 years.\n\nAutoimmune Diseases: Active autoimmune diseases requiring systemic immunosuppressive therapy.\n\nHistory of Severe Cytokine Release Syndrome (CRS): Any history of severe CRS or neurological toxicity following prior CAR-T cell therapy.\n\nAllergy to Apheresis or CAR-T Cell Components: Known hypersensitivity to any of the components involved in the apheresis or CAR-T cell therapy procedure.\n\nUncontrolled Systemic Disease: Uncontrolled comorbid conditions, such as severe cardiovascular disease, uncontrolled hypertension, or severe pulmonary conditions.\n\nConcurrent Participation in Another Clinical Trial: Participation in another clinical trial for AML or related conditions that may interfere with this study's treatment and outcomes.\n\nInability to Comply: Inability to comply with study procedures or follow-up requirements as per the investigator's judgment.","ALL","18 Years","70 Years",{"count":67,"type":68},20,"ESTIMATED","INTERVENTIONAL",[71,72],"PHASE1","PHASE2","This study is a clinical trial designed to evaluate the safety and efficacy of a new type of CAR-T cell therapy for patients with relapsed\u002Frefractory acute myeloid leukemia (AML). The treatment involves modifying the patient's own T cells to target and eliminate leukemia cells more effectively. This is a cutting-edge therapy using anti-CLL1-CD33-NKG2D Bicephali CAR-T cells.\n\nThe primary goal of this study is to determine whether this treatment can improve survival and reduce the symptoms of AML in patients whose disease has not responded to standard treatments. Participants will be closely monitored for side effects and the overall effectiveness of the treatment.\n\nEligibility for this study includes patients who have been diagnosed with relapsed or refractory AML and have not had success with previous therapies. Participation in this study will provide access to an experimental treatment that may offer benefits beyond current treatment options, but also comes with risks.\n\nPatients, their families, and healthcare providers will be provided with full information about the procedure, potential benefits, and risks, and they will have the opportunity to ask questions before deciding whether to participate.",[75],"AML (Acute Myeloid Leukemia)",[9],"NOT_YET_RECRUITING","2026-01-18",{"date":80,"type":81},"2026-01-27","ACTUAL",{"date":83,"type":68},"2026-01-31",{"date":85,"type":68},"2029-01-31",{"name":5,"class":6},1]