[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538184":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":33,"locations":42,"responsibleParty":125,"collaborators":28,"id":127,"slug":128,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":28,"eligibilityCriteria":133,"healthyVolunteers":129,"sex":134,"minAge":135,"maxAge":28,"enrollmentInfo":136,"targetDuration":28,"studyType":139,"phases":140,"briefSummary":142,"conditions":143,"keywords":150,"overallStatus":45,"whyStopped":28,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},{"fullName":5,"class":6},"Memorial Sloan Kettering Cancer Center","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Level 1","EXPERIMENTAL","0.5x106 CAR-T cell\u002Fkg without lymphodepleting chemotherapy (LDC)",[13],"Biological: 19-28z\u002FIL-18 CAR T cells",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose Level 2","0.5x106 cells\u002Fkg with lymphodepleting chemotherapy (LDC)",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Dose Level 3","1x106 cells\u002Fkg with lymphodepleting chemotherapy (LDC)",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"BIOLOGICAL","19-28z\u002FIL-18 CAR T cells","19-28z\u002FIL-18 CAR T cells are an investigational new drug (IND) for the treatment of R\u002FR B-ALL",[9,15,19],null,[30],{"name":31,"affiliation":5,"role":32},"Jae Park, MD","PRINCIPAL_INVESTIGATOR",[34,38],{"name":31,"role":35,"phone":36,"phoneExt":28,"email":37},"CONTACT","646-608-3743","parkj6@mskcc.org",{"name":39,"role":35,"phone":40,"phoneExt":28,"email":41},"Mark Geyer, MD","646-608-3745","geyerm@mskcc.org",[43,59,70,81,93,104,114],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)","RECRUITING","Basking Ridge","New Jersey","07920","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-74.54932,40.70621,{"lat":55,"lon":54},[58],{"name":31,"role":35,"phone":36,"phoneExt":28,"email":28},{"facility":60,"status":45,"city":61,"state":47,"zip":62,"country":49,"countryCode":50,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Memorial Sloan Kettering Monmouth (Limited Protocol Activities)","Middletown","07748",{"type":52,"coordinates":64},[65,66],-74.11709,40.39428,{"lat":66,"lon":65},[69],{"name":31,"role":35,"phone":36,"phoneExt":28,"email":28},{"facility":71,"status":45,"city":72,"state":47,"zip":73,"country":49,"countryCode":50,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Memorial Sloan Kettering Bergen (Limited Protocol Activities)","Montvale","07645",{"type":52,"coordinates":75},[76,77],-74.02292,41.04676,{"lat":77,"lon":76},[80],{"name":31,"role":35,"phone":36,"phoneExt":28,"email":28},{"facility":82,"status":45,"city":83,"state":84,"zip":85,"country":49,"countryCode":50,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Memorial Sloan Kettering Cancer Suffolk-Commack (Limited Protocol Activities)","Commack","New York","11725",{"type":52,"coordinates":87},[88,89],-73.29289,40.84288,{"lat":89,"lon":88},[92],{"name":31,"role":35,"phone":36,"phoneExt":28,"email":28},{"facility":94,"status":45,"city":95,"state":84,"zip":96,"country":49,"countryCode":50,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Memorial Sloan Kettering Westchester (Limited Protocol Activities)","Harrison","10604",{"type":52,"coordinates":98},[99,100],-73.71263,40.96899,{"lat":100,"lon":99},[103],{"name":31,"role":35,"phone":36,"phoneExt":28,"email":28},{"facility":105,"status":45,"city":84,"state":84,"zip":106,"country":49,"countryCode":50,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Memorial Sloan Kettering Cancer Center (All Protocol Activities)","10065",{"type":52,"coordinates":108},[109,110],-74.00597,40.71427,{"lat":110,"lon":109},[113],{"name":31,"role":35,"phone":36,"phoneExt":28,"email":28},{"facility":115,"status":45,"city":116,"state":84,"zip":117,"country":49,"countryCode":50,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Memorial Sloan Kettering Nassau (Limited Protocol Activities)","Uniondale","11553",{"type":52,"coordinates":119},[120,121],-73.59291,40.70038,{"lat":121,"lon":120},[124],{"name":31,"role":35,"phone":36,"phoneExt":28,"email":28},{"type":126,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100538184","phase-1-a-study-of-19-28zil-18-in-people-with-acute-lymphoblastic-leukemia-all-100538184",false,"NCT06287528","A Study of 19-28z\u002FIL-18 in People With Acute Lymphoblastic Leukemia (ALL)","A Phase I Trial of CD19-targeted Chimeric Antigen Receptor (CAR) T Cells That Constitutively Secrete Interleukin 18 (19-28z\u002FIL-18) in Patients With Relapsed or Refractory (R\u002FR) Acute Lymphoblastic Leukemia (ALL)","Inclusion Criteria:\n\n* Patients must have R\u002FR ALL meeting one of the following criteria:\n* For Philadelphia chromosome (Ph) negative B-ALL: Refractory or relapsed disease to at least 1 prior multiagent systemic chemotherapy regimen that included both induction and consolidation therapy\n* For Philadelphia chromosome (Ph) positive B-ALL: patients must have exhibited persistent or progressive disease following at least 1 prior second- or third-generation tyrosine kinase inhibitor\n* Signed informed consent form (ICF) prior to any study procedures\n* Age: The first 3 patients enrolled into the study will be ≥ 17 years of age at time of enrollment. If a DLT is observed, the additional 3 patients in this cohort will also be ≥ 17 years of age. Additional patients will be ≥12 years of age at time of enrollment.\n* Documentation of CD19 positivity on leukemia blasts if prior anti-CD19 treatment\n* History of prior allogeneic hematopoietic stem cell transplant (HSCT) is allowed if ≥3 months from time of enrollment and no evidence of acute or chronic graft versus host disease (GVHD) within 4 weeks prior to enrollment\n* Donor lymphocyte infusions (DLI) permitted if ≥4 weeks prior to leukapheresis\n* History of secondary CNS or meningeal involvement allowed if:\n\n  * cannot be the only site of disease\n  * absence of neurologic symptoms, such as: seizures, stroke-like deficits, altered mental status, aphasia, or psychosis\n* Adequate organ function at time of screening, including:\n\n  * ALT or AST ≤5x ULN and total bilirubin ≤2 (or ≤3 if history of Gilbert's syndrome or leukemic infiltration of the liver)\n  * Serum creatinine \\\u003C2.0mg\u002F100mL\n  * SaO2 ≥92% on room air\n  * Left ventricular ejection fraction (LVEF) ≥50% within 1 month of screening\n* ECOG performance status 0-1 or Lansky performance status ≥ 60 for patients \\\u003C 16 years old\n* Prior CD19-targeted therapies (including CD19 CAR-T cell and CD19 bispecific T-cell engagers) are allowed including anti-CD19 CAR T therapy, as long as CD19 positivity is confirmed on most recent bone marrow, blood or tumor biopsy\n\nExclusion Criteria:\n\n* Concurrent active malignancy excluding: nonmelanoma skin cancer or localized solid tumor that has undergone definitive therapy and with low risk of recurrence, e.g., prostate, breast\n* Burkitt's leukemia or lymphoma or CML in lymphoid blast crisis\n* Radiologically detected or symptomatic CNS disease or CNS 3 disease (i.e., presence of ≥5\u002FµL WBCs in CSF). Subjects with adequately treated CNS leukemia are eligible.\n* The following medications are excluded:\n\n  * Steroids: Therapeutic doses of corticosteroids (greater than 10mg daily of prednisone or its equivalent) within 7 days of leukapheresis or 72 hours prior to CAR T cell infusion.\n  * Chemotherapy: Systemic chemotherapy should be stopped one week prior to leukapheresis or starting CAR T cell infusion or lymphodepleting chemotherapy. Hydroxyurea for cytoreduction can be administered up to 72 hours before leukapheresis or CAR T cell infusion.\n* History of class III-IV New York Heart Association (NYHA) heart failure, cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac condition within 6 months of screening\n* Patients with history of significant autoimmune disease and\u002For inflammatory condition affecting the CNS are ineligible\n* Systemic treatment for GVHD within 4 weeks prior to enrollment\n* Patients with known severe autoimmune disease (e.g., Crohn's, rheumatoid arthritis, or lupus) that in the investigator's opinion has high likelihood of requiring systemic immune suppressive medications\n* Patients with HIV infection\n* Patients with active hepatitis B infection (as manifested by either detectable hepatitis B virus DNA by PCR and\u002For positivity for hepatitis B surface antigen)\n* Patients with active hepatitis C infection (as manifested by detectable hepatitis C virus RNA by PCR)\n* Patients with uncontrolled systemic fungal, bacterial, viral or other infection including COVID-19 at time of leukapheresis or at time of CAR T cell infusion.\n* Other uncontrolled medical or psychological conditions as well as social or logistical issues that may interfere with compliance with the protocol, as determined by the investigator\n* Treatment with live, attenuated vaccine \\\u003C4 weeks prior to leukapheresis\n* Pregnant or lactating\u002Fbreastfeeding women","ALL","17 Years",{"count":137,"type":138},18,"ESTIMATED","INTERVENTIONAL",[141],"PHASE1","Participants will have a sample of their white blood cells, called T cells, collected using a procedure called leukapheresis. The collected T cells will be sent to a laboratory to be changed (modified) to become 19-28z\u002FIL-18, the CAR T-cell therapy that participants will receive during the study. Making the participants' study therapy will take about 2-4 weeks.",[144,145,146,147,148,149],"Philadelphia-Negative ALL","Philadelphia-Positive ALL","Relapsed ALL, Adult","Refractory Acute Lymphoblastic Leukemia","Refractory Acute Lymphoblastic Leukemia (ALL)","Refractory Acute Lymphoid Leukemia in Relapse",[144,145,151,152,146,147,148,149,153,154,5],"Philadelphia chromosome negative (Ph-negative) B-ALL","Philadelphia chromosome positive (Ph+ positive) B-ALL","19-28z\u002FIL-18","23-307","2026-02-09",{"date":157,"type":158},"2026-02-10","ACTUAL",{"date":160,"type":158},"2024-02-23",{"date":162,"type":138},"2028-02-23",{"name":5,"class":6},7]