[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsed-all-adult\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsed-all-adult":28},{"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":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":49},"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":19,"type":20},18,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28,29,30,31],"Philadelphia-Negative ALL","Philadelphia-Positive ALL","Relapsed ALL, Adult","Refractory Acute Lymphoblastic Leukemia","Refractory Acute Lymphoblastic Leukemia (ALL)","Refractory Acute Lymphoid Leukemia in Relapse",[26,27,33,34,28,29,30,31,35,36,37],"Philadelphia chromosome negative (Ph-negative) B-ALL","Philadelphia chromosome positive (Ph+ positive) B-ALL","19-28z\u002FIL-18","23-307","Memorial Sloan Kettering Cancer Center","RECRUITING","2026-02-09",{"date":41,"type":42},"2026-02-10","ACTUAL",{"date":44,"type":42},"2024-02-23",{"date":46,"type":20},"2028-02-23",{"name":37,"class":48},"OTHER",7]