[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577867":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":34,"responsibleParty":58,"collaborators":62,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":20,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":20,"studyType":78,"phases":79,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":36,"whyStopped":20,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Boston Children's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1 Dose Escalation","EXPERIMENTAL","The dose escalation arm will determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of hALK.CAR T cells using a standard 3+3 dose escalation design.",[13],"Biological: Autologous hALK.CAR T cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Autologous hALK.CAR T cells","Autologous chimeric antigen receptor T cells targeting the human Anaplastic Lymphoma Kinase (ALK) receptor",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Susanne Baumeister, MD","Dana-Farber Cancer Institute","PRINCIPAL_INVESTIGATOR",[27,31],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","617-632-3796","dfbchpedicelltherapy@dfci.harvard.edu",{"name":32,"role":28,"phone":29,"phoneExt":20,"email":33},"Audra Caine","audra_caine@dfci.harvard.edu",[35,51],{"facility":5,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Boston","Massachusetts","02115","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-71.05977,42.35843,{"lat":46,"lon":45},[49,50],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"facility":24,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":52,"geoPoint":54,"contacts":55},{"type":43,"coordinates":53},[45,46],{"lat":46,"lon":45},[56,57],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Roberto Chiarle","Professor in Pathology",[63,64],{"name":5,"class":6},{"name":24,"class":6},"100577867","phase-1-study-of-halkcar-t-cells-for-patients-with-relapsedrefractory-high-risk-neuroblastoma-100577867",false,"NCT06803875","Study of hALK.CAR T Cells for Patients With Relapsed\u002FRefractory High-risk Neuroblastoma","A Phase 1\u002F2 Study of hALK.CAR T Cells for Patients With Relapsed\u002FRefractory High-risk Neuroblastoma","Inclusion Criteria:\n\n1. Age ≥ 12 months and \\\u003C 30 years at the time of consent. The first patient on each dose level will need to be age ≥ 6 years old\n2. Disease Status:\n\n   1. Patients must have histologic verification of neuroblastoma at diagnosis or at relapse\n   2. Patients must have high-risk neuroblastoma according to Children's Oncology Group (COG) risk classification at time of study enrollment\n   3. Patients must have persistent\u002Frefractory or relapsed disease for which standard curative measures are no longer effective, as defined in the protocol\n   4. Patients must have evaluable or measurable disease per the revised International Neuroblastoma Response Criteria (INRC)\n3. Adequate washout from prior treatment regimens\n4. Adequate organ function\n5. Adequate performance status defined as Lansky or Karnofsky performance score ≥50%\n6. Subjects of reproductive potential must agree to use acceptable birth control methods\n7. Signed informed consent\n\nExclusion Criteria:\n\n1. Pregnant or nursing (lactating) women\n2. Patients with uncontrolled active infection\n3. Patients who are concurrently receiving other investigational agents\n4. Patients who have received prior CART-cell or other gene-modified immune-effector cell therapy, are not eligible unless they are \\>8 weeks from time of infusion, have fully recovered from any associated toxicities and have documented lack of persistence of the product\n5. Patients with a known additional malignancy other than non-melanomatous skin cancer or carcinoma in situ, unless not requiring active treatment and stable or disease-free for at least 3 years\n6. Uncontrolled CNS metastasis\n7. CNS disorder such as cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or autoimmune disease with CNS involvement which may impair the ability to evaluate neurotoxicity\n8. History of severe hypersensitivity reaction to compounds used in the study\n9. HIV\u002FHBV\u002FHCV infection\n10. Patients receiving systemic steroid therapy (physiologic replacement, inhaled steroids and premedication for blood products are allowed)\n11. Primary immunodeficiency or history of systemic autoimmune disease requiring systemic immunosuppression\u002Fdisease modifying agents within the last 2 years\n12. Uncontrolled intercurrent illness\n13. Inability to comply with the study requirements","ALL","12 Months","29 Years",{"count":76,"type":77},42,"ESTIMATED","INTERVENTIONAL",[80,81],"PHASE1","PHASE2","This Phase 1\u002F2 trial aims to determine the safety and feasibility of administration of autologous chimeric antigen receptor (CAR) T cells targeting the human Anaplastic Lymphoma Kinase (ALK) receptor in pediatric subjects with relapsed or refractory neuroblastoma (NB).\n\nThe trial will be conducted in two phases:\n\nPhase 1 will determine the maximum tolerated dose (MTD) of autologous hALK.CAR T cells using a 3+3 dose escalation design. Phase 2 will be an expansion phase to determine rates of response to hALK.CAR T cells.",[84,85,86],"Relapsed Neuroblastoma","Refractory Neuroblastoma","High-risk Neuroblastoma",[84,85,88],"High-Risk Neuroblastoma","2025-12-24",{"date":91,"type":92},"2025-12-26","ACTUAL",{"date":94,"type":92},"2025-01-31",{"date":96,"type":77},"2029-12-31",{"name":60,"class":6},2]