[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100430143":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":59,"centralContacts":65,"locations":70,"responsibleParty":88,"collaborators":29,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":29,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":29,"maxAge":98,"enrollmentInfo":99,"targetDuration":29,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":29,"overallStatus":72,"whyStopped":29,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"St. Jude Children's Research Hospital","OTHER",[8,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A","EXPERIMENTAL","Participants in group A have received a prior stem cell transplant from their CAR T-cell donor.",[13,14,15,16,17,18],"Biological: CD19-CAR(Mem) T-cells","Drug: Cyclophosphamide","Drug: Fludarabine","Drug: Mesna","Device: CliniMACS","Procedure: Leukapheresis",{"label":20,"type":10,"description":21,"interventionNames":22},"Group B","Participants in group B have not received a prior stem cell transplant from their CAR T-cell donor.",[13,14,15,16,17,18],[24,30,37,43,49,54],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"BIOLOGICAL","CD19-CAR(Mem) T-cells","Allogeneic CD19-CAR.CD45RA-negative T-cells Intravenous infusion",[9,20],null,{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Cyclophosphamide","Cyclophosphamide is a nitrogen mustard derivative. It acts as an alkylating agent that causes cross-linking of DNA strands by binding with nucleic acids and other intracellular structures, thus interfering with the normal function of DNA.",[9,20],[36],"Cytoxan",{"type":31,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Fludarabine","Fludarabine phosphate is a synthetic purine nucleoside analog. It acts by inhibiting DNA polymerase, ribonucleotide reductase and DNA primase by competing with the physiologic substrate, deoxyadenosine triphosphate, resulting in inhibition of DNA synthesis.",[9,20],[42],"Fludara",{"type":31,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Mesna","Mesna is a synthetic sulfhydryl (thiol) compound. Mesna contains free sulfhydryl groups that interact chemically with urotoxic metabolites of oxaza-phosphorine derivatives such as cyclophosphamide and ifosfamide.",[9,20],[48],"Mesnex",{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":29},"DEVICE","CliniMACS","A CliniMACS device is used to select donor T-cells for manufacturing of the memory CAR T-cell product.",[9,20],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":29},"PROCEDURE","Leukapheresis","Leukapheresis is performed to collect the T cells that are needed to generate the CD19-CAR.CD45RA-negative T-cells product for the clinic study.",[9,20],[60,63],{"name":61,"affiliation":5,"role":62},"Aimee C. Talleur, MD","PRINCIPAL_INVESTIGATOR",{"name":64,"affiliation":5,"role":62},"Stephen Gottschalk, MD",[66],{"name":61,"role":67,"phone":68,"phoneExt":29,"email":69},"CONTACT","866-278-5833","referralinfo@stjude.org",[71],{"facility":5,"status":72,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"RECRUITING","Memphis","Tennessee","38105","United States","US",{"type":79,"coordinates":80},"Point",[81,82],-90.04898,35.14953,{"lat":82,"lon":81},[85,86,87],{"name":61,"role":67,"phone":68,"phoneExt":29,"email":69},{"name":61,"role":62,"phone":29,"phoneExt":29,"email":29},{"name":64,"role":62,"phone":29,"phoneExt":29,"email":29},{"type":89,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100430143","phase-1-study-of-cd19-allogeneic-memory-t-cell-therapy-for-relapsedrefractory-cd19-leukemia-100430143",false,"NCT04881240","Study of CD19 Allogeneic Memory T-cell Therapy for Relapsed\u002FRefractory CD19+ Leukemia","A Phase I Study Evaluating Allogeneic Memory T Cells Engineered to Express Chimeric Antigen Receptors Specific for CD19 for the Treatment of Pediatric and Young Adult Patients ≤ 21 Years of Age With Relapsed or Refractory CD19-Positive Leukemia","Inclusion Criteria Eligibility Criteria for Donors: Apheresis and Manufacturing\n\n* Age ≥ 18 years old\n* At least single haplotype matched (≥ 3\u002F6) family member\n* HIV negative\n* For females of child bearing age: Not pregnant as confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment AND Not lactating with intent to breastfeed\n* Completed the process of donor eligibility determination as outlined in 21 CFR 1271 and agency guidance\n\nFor Cohort A only, identified recipient with relapsed and\u002For refractory CD19-positive leukemia\n\nFor Cohort B only, iIdentified recipient with relapsed and\u002For refractory CD19-positive leukemia who is not suitable to receive autologous CD19-CAR T-cell therapy as defined by the following:\n\n* Relapsed and\u002For refractory disease despite prior treatment with autologous CD19- CAR T-cell therapy\n* History of prior autologous leukapheresis failure\n* History of prior autologous CAR T-cell manufacturing failure\n* Unable to undergo autologous leukapheresis in the opinion of the study PI(s): examples may include - patient small size\u002Flow weight, inadequate T-cell counts, rapidly progressive leukemia, clinical status not amenable to apheresis\n\nEligibility Criteria for Patients: Treatment\n\n* Age ≤ 21 years old\n* Relapsed and\u002For refractory CD19-positive leukemia\\*:\n\n  * Refractory disease (defined as any of the following):\n\n    * Primary refractory disease despite at least 2 cycles of an intensive chemotherapy regimen designed to induce remission\n    * Refractory disease despite salvage therapy\n  * Relapsed disease (defined as any of the following):\n\n    * 2nd or greater relapse\n    * Any relapse after allogeneic hematopoietic cell transplantation (HCT)\n    * 1st relapse if patient requires an allogeneic HCT as part of standard of care relapse therapy, but is found to be ineligible and\u002For unsuitable for HCT\n\nCD19-positivity confirmed within 2 months and after receipt of any CD19-directed therapy\n\n* Patient cohorts:\n\n  * Cohort A: patient has previously received a HCT from the selected CAR T-cell donor\n  * Cohort B - patient has NOT previously received a HCT from the selected CAR T-cell donor.\n* For Cohort B only, not suitable to receive autologous CD19-CAR T-cell therapy as defined above in Criteria: Eligibility Criteria for Donors: Apheresis and Manufacturing\n* Detectable medullary CD19-positive leukemia\n* Estimated life expectancy of ≥ 8 weeks\n* Karnofsky or Lansky performance score ≥ 50\n* No CNS-3 disease or any level of detectable leukemia in CNS with associated neurologic symptoms\n* If history of allogeneic HCT (regardless of donor type), prior to planned CAR T-cell infusion, must meet the following criteria:\n\n  * ≥ 3 months from HCT\n  * have recovered from prior HCT therapy\n  * have no evidence of active GVHD within prior 2 months\n  * have not received a donor lymphocyte infusion (DLI) within the 28 days prior to planned CAR T-cell infusion\n* Adequate cardiac function: left ventricular ejection fraction ≥ 40% or shortening fraction ≥ 25% (function may be supported by pharmacologic therapy)\n* EKG without evidence of clinically significant arrhythmia\n* Adequate renal function: creatinine clearance or radioisotope GFR 50 ml\u002Fmin\u002F1.73m2 (GFR 40 ml\u002Fmin\u002F1.73m2 if \\\u003C 2 years of age)\n* Adequate pulmonary function: forced vital capacity (FVC) ≥ 50% of predicted value; or pulse oximetry ≥ 92% on room air if patient is unable to perform pulmonary function testing\n* Total bilirubin ≤ 3 times the upper limit of normal for age, except in subjects with Gilbert's syndrome\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5 times the upper limit of normal for age\n* No history of HIV infection\n* No evidence of severe, uncontrolled bacterial, viral or fungal infection\n* Has recovered from all NCI CTAE grade III-IV, non-hematologic acute toxicities from prior therapy\n* For females of child bearing age:\n\n  * Not pregnant with negative serum or urine pregnancy test ≤ 7 days prior to enrollment AND Not lactating with intent to breastfeed\n* If sexually active, agreement to use birth control until 6 months after CAR T-cell infusion\n* No history of hypersensitivity reactions to murine protein-containing products\n* Not receiving systemic steroids therapy exceeding the equivalent of 0.5 mg\u002Fkg\u002Fday of methylprednisolone ≤ 7 days prior to CAR T-cell infusion\n* Not receiving systemic therapy ≤ 14 days prior to CAR T-cell infusion, which will interfere with the activity of the CAR T-cell product in vivo (in the opinion of the study PI(s))\n* Not receiving intrathecal chemotherapy ≤ 7 days prior to CAR T-cell infusion\n\nExclusion Criteria:\n\nNA","ALL","21 Years",{"count":100,"type":101},60,"ESTIMATED","INTERVENTIONAL",[104],"PHASE1","This is a Phase I clinical study evaluating the safety and maximum tolerated dose of a novel CAR T-cell product: allogeneic memory (CD45RA- negative) T-cells expressing a CD19-specific CAR 41BBz (CD19-CAR.CD45RA- negative T-cells) for the treatment of patients ≤ 21 years old with relapsed and\u002F or refractory CD19-positive leukemia.\n\nPrimary Objective\n\nTo determine the maximum tolerated dose (MTD) and characterize the safety profile and dose-limiting toxicities (DLTs) of treatment with allogeneic CD19-CAR.CD45RA-negative T-cells in pediatric, adolescent and young adult patients ≤ 21 years of age, with relapsed and\u002For refractory CD19-positive leukemia.\n\nSecondary Objectives\n\n* To evaluate the anti-leukemic activity of allogeneic CD19-CAR.CD45RA-negative T-cells.\n* To determine rates and severity of graft-versus-host-disease (GVHD) after treatment with allogeneic CD19-CAR.CD45RA-negative T-cells.\n\nExploratory Objectives\n\n* To study the expansion, persistence and phenotype of allogeneic CD19-CAR.CD45RA-negative T-cells.\n* To characterize the cytokine profile in the peripheral blood and CSF after treatment with allogeneic CD19-CAR.CD45RA-negative T-cells.\n* To assess whether allogeneic CD19-CAR.CD45RA-negative T-cells acquire functional versus exhaustion-associated epigenetic programs.\n* To determine immune reconstitution post treatment, and the clonal structure and endogenous repertoire of allogeneic CD19-CAR.CD45RA-negative T-cells and relate inferred specificity to CAR response profiles.\n* To characterize incidence and mechanisms of relapse post-therapy with allogeneic CD19-CAR.CD45RA-negative T-cells.",[107,108,109],"Acute Lymphoblastic Leukemia, in Relapse","Acute Lymphoblastic Leukemia, Refractory","Pediatric ALL","2026-05-20",{"date":112,"type":113},"2026-05-26","ACTUAL",{"date":115,"type":113},"2024-02-14",{"date":117,"type":101},"2028-07-01",{"name":5,"class":6},1]