[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100404304":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":56,"collaborators":58,"id":60,"slug":24,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":24,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":24,"studyType":72,"phases":73,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":41,"whyStopped":24,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase I: Dose Escalation","EXPERIMENTAL","First 4-18 subjects enrolled. Treated with escalating doses of therapy until the recommended phase 2 dose (RP2D) is determined.",[13],"Drug: CD19CAR-CD3Zeta-4-1BB-Expressing Autologous T-Lymphocyte Cells",{"label":15,"type":10,"description":16,"interventionNames":17},"Phase II: Dose Expansion","Up to 18 additional subjects will be treated at the recommended Phase 2 dose (RP2D) to allow for 12 total subjects to be treated in each cohort, including those treated within the phase 1 portion at the RP2D.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","CD19CAR-CD3Zeta-4-1BB-Expressing Autologous T-Lymphocyte Cells","The CD19 CAR used in this study consists of three main components: the variable regions of the anti-CD19 monoclonal antibody FMC63 71, linked to the TNFRSF-19-derived transmembrane domain, the 4-1BB costimulatory molecule, and the signaling domain of the CD3-zeta molecule. The DNA encoding this receptor was cloned into a lentiviral vector (LV) backbone.",[9,15],null,[26],{"name":27,"affiliation":28,"role":29},"Vanessa Fabrizio, MD, MS","Children's Hospital Colorado","PRINCIPAL_INVESTIGATOR",[31,35],{"name":27,"role":32,"phone":33,"phoneExt":24,"email":34},"CONTACT","720-777-6860","BMT@childrenscolorado.org",{"name":36,"role":32,"phone":37,"phoneExt":24,"email":38},"Kayla Ortiz","720-777-2564","kayla.ortiz@childrenscolorado.org",[40],{"facility":28,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Aurora","Colorado","80045","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-104.83192,39.72943,{"lat":51,"lon":50},[54,55],{"name":27,"role":32,"phone":33,"phoneExt":24,"email":34},{"name":27,"role":29,"phone":24,"phoneExt":24,"email":24},{"type":57,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[59],{"name":28,"class":6},"100404304",false,"NCT04544592","UCD19 CarT in Treatment of Pediatric B-ALL and B-NHL","Phase I\u002FII Dose Escalation and Preliminary Efficacy of CD19 Directed CAR-T Cells Generated Using the Miltenyi CliniMACs Prodigy System (UCD19 CAR-T) in Pediatric Patients With Relapsed and\u002For Refractory B-Cell Acute Lymphoblastic Leukemia (B-ALL) and B-Cell Non-Hodgkin Lymphoma (B-NHL)","Inclusion Criteria:\n\n* Meets clinical criteria for leukapheresis or has a leukapheresis product previously collected and stored per recommended guidelines.\n* Provision of signed and dated consent form from parent or guardian (patients \\\u003C18), the patient themselves (\\>18), or legally authorized representative (patient \\>18 who lack decision-making capacity); Pediatric patients will be included in age-appropriate discussions and assent will be obtained for those \\> 7 years of age, when appropriate, according to institutional standards.\n* Willingness to participate in long term follow up study.\n* Stated willingness to comply with all study procedures and be available for the duration of the study.\n* Males OR non-pregnant, non-breastfeeding females.\n\n  o Patients of child-bearing potential or capable of fathering a child must agree to use highly effective contraception from the time of initial CAR T cell administration though 12 months following the final administration of investigational product.\n* Aged 31 days to 30 years (inclusive) at time of consent and enrollment.\n* Acute Lymphoblastic Leukemia (ALL) OR Non-Hodgkin Lymphoma (NHL) of B-cell origin that:\n\n  * Has confirmed expression of CD19 by flow cytometry, immunohistochemistry (IHC), or both.\n\nCohort One Criteria:\n\n* Meets any one of the following conditions:\n\n  * Relapsed two or more times\n  * Relapsed at any time after allogeneic BMT\n  * Refractory to standard therapy as determined by the treating physician\n  * Meets criteria for BMT but is ineligible as determined by the treating physician Patient and\u002For parents declining BMT options and would prefer CAR-T Therapy.\n* Non-Hodgkin Lymphoma includes all of the following:\n\n  * Diffuse large B-cell lymphoma (DLBCL)\n  * Burkitt Lymphoma\n  * Intermediate lymphoma between Burkitt and DLBCL\n  * Primary Mediastinal B-cell Lymphoma (PMBL)\n  * Follicular lymphoma\n  * High grade B cell lymphoma\n  * Transformed lymphoma\n\nCohort Two Criteria:\n\n* B-ALL in first relapse with any one of the following conditions:\n\n  * High-risk genomic alterations at initial diagnosis such as KMT2A gene rearrangement, t(17;19), hypodiploidy, Ph-like mutations, BCR-ABL1 fusion (Ph+ ALL), iAMP21, and TP53 inactivating mutation\u002Fdeletion.\n  * Isolated CNS relapse such that cranial radiation would be indicated as a component of standard salvage therapy.\n  * Down syndrome.\n  * Minimal residual disease (MRD) positivity of \\> 0.01% by FACS or \\> 0 clonal sequences by NGS in bone marrow post re-induction chemotherapy.\n  * Age 18 years or older. OR Newly diagnosed with persistent MRD ≥ 0.01% by flow cytometry in bone marrow at end of consolidation.\n* Performance score (Lansky or Karnofsky) of 50% or better;\n* Unable to or declined to receive commercially available CD19 CAR-T Therapy.\n\nExclusion Criteria:\n\n* Evidence of rapidly progressive disease without adequate salvage\u002Fbridging regimens as determined by the investigator.\n* Active Graft-versus-Host Disease (GvHD).\n* Active, uncontrolled, life-threatening infection that at the determination of the treating physician would preclude safe leukapheresis or tolerance of LD chemotherapy, cell infusion, or cytokine release syndrome.\n* Evidence of severe organ dysfunction as defined by:\n\n  * Myocardial dysfunction: Ejection fraction ≤ 40% or shortening fraction ≤ 28%, evidence of physiologically significant pericardial effusion as determined by an echocardiogram (ECHO), and clinically significant electrocardiogram (ECG) findings.\n  * Baseline oxygen saturation of ≤ 90% on room air\n  * Transaminases \\> 10x upper limit of normal (ULN) or bilirubin \\>2x the ULN, unless thought to be related to primary disease\n  * Estimated Cr clearance \\\u003C60 mL\u002Fmin\u002F1.73 m2 (if nuclear medicine GFR or other more specific testing exceeds this level than it can supersede the estimated clearance)\n* Post-pubertal females that are pregnant, planning to become pregnant, or unwilling to use birth control (includes abstinence) for the study duration.\n* Known HIV infection, or active Hepatitis B or active Hepatitis C infection.","ALL","31 Days","30 Years",{"count":70,"type":71},45,"ESTIMATED","INTERVENTIONAL",[74,75],"PHASE1","PHASE2","This phase I\u002FII trial will investigate a new CD19 directed CAR-T therapy manufactured locally with the goals to expedite infusion to wider patient inclusion that includes those who were previously excluded, such as pediatric patients with B-cell NHL and patients in primary relapse.",[78,79],"B-cell Acute Lymphoblastic Leukemia","B-cell Non Hodgkin Lymphoma",[81,82,83,84,85,86,87,88],"CD19","CAR-T","pediatric","relapsed","refractory","B-ALL","B-NHL","Miltenyi CliniMACS Prodigy","2026-04-16",{"date":91,"type":92},"2026-04-20","ACTUAL",{"date":94,"type":92},"2021-03-10",{"date":96,"type":71},"2026-07",{"name":5,"class":6},1]