[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541177":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":42,"centralContacts":47,"locations":52,"responsibleParty":69,"collaborators":35,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":35,"eligibilityCriteria":76,"healthyVolunteers":73,"sex":77,"minAge":35,"maxAge":78,"enrollmentInfo":79,"targetDuration":35,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":35,"overallStatus":54,"whyStopped":35,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"St. Jude Children's Research Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CD70- CAR T cell Therapy","EXPERIMENTAL","Patients will receive autologous (their own) cells.",[13,14,15,16],"Drug: Fludarabine","Drug: Cyclophosphamide","Drug: CD70-CAR T cell infusion (Autologous)","Drug: Mesna",[18,25,31,36],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Fludarabine","40mg\u002Fm2, Day -4, -3 and -2",[9],[24],"Fludara",{"type":19,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"Cyclophosphamide","Day -3 and Day-2\n\nREST DAY, -1",[9],[30],"Cytoxan",{"type":19,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"CD70-CAR T cell infusion (Autologous)","Day 0 or +1",[9],null,{"type":19,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Mesna","Mesna is generally dosed at approximately 25% of the cyclophosphamide dose. It is generally given intravenously prior to and again at 3, 6 and 9 hours following each dose of cyclophosphamide",[9],[41],"Mesnex",[43],{"name":44,"affiliation":45,"role":46},"Swati Naik, MBBS","St. Jude","PRINCIPAL_INVESTIGATOR",[48],{"name":44,"role":49,"phone":50,"phoneExt":35,"email":51},"CONTACT","866-278-5833","referralinfo@stjude.org",[53],{"facility":5,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"RECRUITING","Memphis","Tennessee","38105","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-90.04898,35.14953,{"lat":64,"lon":63},[67],{"name":68,"role":49,"phone":50,"phoneExt":35,"email":51},"Swati Naik, MD",{"type":70,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100541177","phase-1-car-t-cell-therapy-directed-to-cd70-for-pediatric-patients-with-hematological-malignancies-100541177",false,"NCT06326463","CAR T-cell Therapy Directed to CD70 for Pediatric Patients With Hematological Malignancies","Inclusion Criteria\n\nAge ≤21 years old\n\nRelapsed\u002Frefractory CD70+ hematological malignancy\n\nRelapsed disease: Patients developing recurrent disease after a prior complete remission (CR)\n\nRefractory disease: Patients with persistent disease despite 3 cycles of induction chemotherapy.\n\n* Relapsed\u002Frefractory CD70+ AML or MDS:\n\n  * Relapsed disease that is CD70 positive\n  * Refractory disease that is persistent despite 3 cycles of chemotherapy\n* Relapsed\u002Frefractory CD70+ B-cell ALL:\n\n  * Relapsed disease that is CD70 positive and CD19 negative\u002Fdim or patients otherwise ineligible for CD19-directed therapies including:\n  * Patients in 2nd or greater relapse\n  * Patients with relapse after allogeneic HSCT\n* Relapsed\u002Frefractory CD70+ T-cell ALL:\n\n  * Relapsed \u002Frefractory disease that is CD70 positive\n* Mixed Phenotype Acute Leukemia (MPAL):\n\n  * Relapsed\u002Frefractory that is CD70 positive\n* Relapsed\u002Frefractory CD70+ lymphoma:\n\n  * Relapsed disease that is CD70 positive and CD19 negative\u002Fdim or patients otherwise ineligible for CD19-directed therapies including:\n  * Patients in 2nd or greater relapse\n  * Patients with relapse after allogeneic HSCT\n\nEstimated life expectancy of \\>12 weeks\n\nKarnofsky or Lansky (age- dependent) performance score ≥50\n\nPatients with a history of prior allogeneic HCT must be clinically recovered from prior HCT therapy, have no evidence of active GVHD and have not received a donor lymphocyte infusion (DLI) within the 28 days prior to apheresis\n\nPatient must have an identified HCT donor\n\nFor females of childbearing age:\n\ni. Not lactating with intent to breastfeed\n\nii. Not pregnant with negative serum or urine pregnancy test within 7 days prior to enrollment\n\nExclusion Criteria\n\n* Known primary immunodeficiency\n* Known history of HIV positivity\n* Severe intercurrent bacterial, viral or fungal infection\n* History of hypersensitivity to cornstarch or hydroxyethyl starch\n* Patients with acute promyelocytic leukemia (APL)\n* Known contraindication to protocol defined lymphodepleting\n* chemotherapy regimen of Fludarabine\u002Fcyclophosphamide","ALL","21 Years",{"count":80,"type":81},18,"ESTIMATED","INTERVENTIONAL",[84],"PHASE1","The study participant has one of the following blood cancers: acute myelogenous leukemia (AML)\u002Fmyelodysplastic syndrome (MDS), acute lymphoblastic leukemia (B-ALL, T-ALL) or Lymphoma. Your cancer has been difficult to treat (refractory) or has come back after treatment (relapse).\n\nPrimary Objective\n\nTo determine the safety and maximum tolerated dose of intravenous infusions of escalating doses of CD70-CAR T cells in patients (≤21 years) with recurrent\u002Frefractory CD70+ hematological malignancies after lymphodepleting chemotherapy.\n\nSecondary Objectives\n\nTo evaluate the antileukemic activity of CD70-CAR T cells. We will determine the anti- leukemic activity of the CD70-CAR T cells in the bone marrow and in the treatment of extramedullary disease.",[87,88,89,90,91],"Hematologic Malignancy","ALL, Childhood","AML, Childhood","Lymphoma","MDS","2026-01-22",{"date":94,"type":95},"2026-01-23","ACTUAL",{"date":97,"type":95},"2024-10-16",{"date":99,"type":81},"2031-07-01",{"name":5,"class":6},1]