{"preliminary_commentary":{"by_channel":{"youtube":1,"podcast":1,"x_thread":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":[],"indication":"pediatric and young adult relapsed/refractory CD19+ acute leukemia","name":"PLAT-02","nct_id":"NCT02028455","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=plat-02-nct02028455. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"This phase 1 cohort will receive Patient Derived CD19 specific CAR T cells at a dose of 5x10\\^5 CAR T cells/kg","label":"Phase 1 - Cohort 1A","type":"EXPERIMENTAL"},{"description":"This phase 1 cohort will receive Patient Derived CD19 specific CAR T cells at a dose of 1x10\\^6 CAR T cells/kg","label":"Phase 1 - Cohort 1B","type":"EXPERIMENTAL"},{"description":"This phase 1 cohort will receive Patient Derived CD19 specific CAR T cells at a dose of 5x10\\^6 CAR T cells/kg","label":"Phase 1 - Cohort 1C","type":"EXPERIMENTAL"},{"description":"This phase 1 cohort will receive Patient Derived CD19 specific CAR T cells at a dose of 1x10\\^7 CAR T cells/kg","label":"Phase 1 - Cohort 1D","type":"EXPERIMENTAL"},{"description":"This phase 1 cohort will receive Patient Derived CD19 specific CAR T cells at a dose of 5x10\\^5 CAR T cells/kg following prescribed lymph-depletion with fludarabine and cyclophosphamide","label":"Phase 1 - Cohort 1F1","type":"EXPERIMENTAL"},{"description":"This phase 1 cohort will receive Patient Derived CD19 specific CAR T cells at a dose of 1x10\\^6 CAR T cells/kg following prescribed lymph-depletion with fludarabine and cyclophosphamide","label":"Phase 1 - Cohort 1F2","type":"EXPERIMENTAL"},{"description":"The phase 2 cohort will receive Patient Derived CD19 specific CAR T cells at a dose of 1 x 10\\^6 CAR T cells/kg following lymphodepletion if indicated.","label":"Phase 2","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2036-07","type":"ESTIMATED"},"conditions":["CD19+ Acute Leukemia"],"enrollment":{"count":167,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Patient Derived CD19 specific CAR T cells also expressing an EGFRt","otherNames":[],"type":"BIOLOGICAL"}],"last_update":"2026-08-06","lead_sponsor":"Seattle Children's Hospital","official_title":"Pediatric and Young Adult Leukemia Adoptive Therapy (PLAT)-02: A Phase 1/2 Feasibility and Safety Study of CD19-CAR T Cell Immunotherapy for CD19+ Leukemia","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2021-08-10","type":"ACTUAL"},"primary_outcomes":[{"measure":"Number of Participants Who Experienced an Adverse Event Meeting the Dose-Limiting Toxicity Definition","timeFrame":"Initial CAR T cell infusion through 30 days post infusion"},{"measure":"Number of Participants With an MRD Negative Complete Remission After Initial CAR T Cell Infusion","timeFrame":"Initial CAR T cell infusion through Day 63 post infusion assessment (+/- 14 days)"},{"measure":"Number of Participants Who Have a Releasable Cell Product Generated","timeFrame":"Up to 28 days per manufacturing attempt"}],"references":[{"citation":"Annesley C, Seidel K, Wu Q, Summers C, Wayne AS, Pulsipher MA, Agrawal AK, Brown CT, Mgebroff S, Lindgren C, Rawlings-Rhea S, Huang W, Wilson AL, Jensen MC, Park JR, Gardner RA. Outcomes of PLAT-02 and PLAT-03: evaluating CD19 CAR T-cell therapy and CD19-expressing T-APC support in pediatric B-ALL. Blood. 2025 Aug 14;146(7):789-801. doi: 10.1182/blood.2025028359.","pmid":"40233328","type":"DERIVED"},{"citation":"Ceppi F, Wilson AL, Annesley C, Kimmerly GR, Summers C, Brand A, Seidel K, Wu QV, Beebe A, Brown C, Mgebroff S, Lindgren C, Rawlings-Rhea SD, Huang W, Pulsipher MA, Wayne AS, Park JR, Jensen MC, Gardner RA. Modified Manufacturing Process Modulates CD19CAR T-cell Engraftment Fitness and Leukemia-Free Survival in Pediatric and Young Adult Subjects. Cancer Immunol Res. 2022 Jul 1;10(7):856-870. doi: 10.1158/2326-6066.CIR-21-0501.","pmid":"35580141","type":"DERIVED"},{"citation":"Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.","pmid":"34515338","type":"DERIVED"},{"citation":"Finney OC, Brakke HM, Rawlings-Rhea S, Hicks R, Doolittle D, Lopez M, Futrell RB, Orentas RJ, Li D, Gardner RA, Jensen MC. CD19 CAR T cell product and disease attributes predict leukemia remission durability. J Clin Invest. 2019 Mar 12;129(5):2123-2132. doi: 10.1172/JCI125423. Print 2019 May 1.","pmid":"30860496","type":"DERIVED"},{"citation":"Gardner RA, Finney O, Annesley C, Brakke H, Summers C, Leger K, Bleakley M, Brown C, Mgebroff S, Kelly-Spratt KS, Hoglund V, Lindgren C, Oron AP, Li D, Riddell SR, Park JR, Jensen MC. Intent-to-treat leukemia remission by CD19 CAR T cells of defined formulation and dose in children and young adults. Blood. 2017 Jun 22;129(25):3322-3331. doi: 10.1182/blood-2017-02-769208. Epub 2017 Apr 13.","pmid":"28408462","type":"DERIVED"},{"citation":"Gardner R, Wu D, Cherian S, Fang M, Hanafi LA, Finney O, Smithers H, Jensen MC, Riddell SR, Maloney DG, Turtle CJ. Acquisition of a CD19-negative myeloid phenotype allows immune escape of MLL-rearranged B-ALL from CD19 CAR-T-cell therapy. Blood. 2016 May 19;127(20):2406-10. doi: 10.1182/blood-2015-08-665547. Epub 2016 Feb 23.","pmid":"26907630","type":"DERIVED"}],"start_date":{"date":"2014-02-11","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Pediatric and Young Adult Trial of Genetically Modified T Cells Directed Against CD19 for Relapsed/Refractory CD19+ Leukemia","url":"https://clinicaltrials.gov/study/NCT02028455"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/plat-02-nct02028455"}