{"preliminary_commentary":{"by_channel":{"x_thread":3},"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":null,"indication":null,"name":"NCT02159495","nct_id":"NCT02159495","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct02159495. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. 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_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Patients undergo a lymphodepleting regimen 3-10 days prior to CD123+ CAR T cell infusion as determined by the principal investigator and the protocol team. Patients receive either cyclophosphamide IV on days -4 and/or -3; fludarabine phosphate and cyclophosphamide IV on days -5 to -3; fludarabine phosphate IV on days -5 to -3 and cyclophosphamide IV on days -4 and/or -3. Patients receive autologous or allogeneic CD123+ CAR Tcells IV over 15 minutes on day 0. Patients with evidence of disease at \\> 28 days, continuing expression of the CD123 antigen, and not having experienced a DLT may receive a second infusion of CD123+ CAR T cells after 28 days.","label":"Treatment (lymphodepletion, T-cell immunotherapy)","type":"EXPERIMENTAL"}],"collaborators":["National Cancer Institute (NCI)","Mustang Bio, Inc."],"completion_date":{"date":"2027-07-14","type":"ESTIMATED"},"conditions":["Adult Acute Myeloid Leukemia in Remission","Acute Biphenotypic Leukemia","Early Relapse of Acute Myeloid Leukemia","Late Relapse of Acute Myeloid Leukemia","Recurrent Adult Acute Myeloid Leukemia","Secondary Acute Myeloid Leukemia","Blastic Plasmacytoid Dendritic Cell Neoplasm","Acute Myeloid Leukemia","Adult Acute Lymphoblastic Leukemia","Interleukin-3 Receptor Subunit Alpha Positive","Minimal Residual Disease","Refractory Acute Myeloid Leukemia","Untreated Adult Acute Myeloid Leukemia"],"enrollment":{"count":31,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"cyclophosphamide","otherNames":["CPM","CTX","Cytoxan","Endoxan","Endoxana"],"type":"DRUG"},{"name":"Autologous CD123CAR-CD28-CD3zeta-EGFRt-expressing T Lymphocytes","otherNames":["CD123R(EQ)28zeta/EGFRt+ T cells","Anti CD123-CAR/CD28-costimulatory Lentiviral Vector-transduced Autologous T Lymphocytes"],"type":"BIOLOGICAL"},{"name":"laboratory biomarker analysis","otherNames":[],"type":"OTHER"},{"name":"Allogeneic CD123CAR-CD28-CD3zeta-EGFRt-expressing T-lymphocytes","otherNames":["Allogeneic CD123R(EQ)28zeta/EGFRt+ T Cells"],"type":"BIOLOGICAL"},{"name":"Fludarabine Phosphate","otherNames":["2-F-ara-AMP","9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-.beta.-D-arabinofuranosyl)-","Beneflur","Fludara","Oforta","SH T 586"],"type":"DRUG"}],"last_update":"2026-08-26","lead_sponsor":"City of Hope Medical Center","official_title":"Phase I Study of Cellular Immunotherapy Using T Cells Lentivirally Transduced to Express a CD123-Specific, Hinge-Optimized, CD28-Costimulatory Chimeric Antigen Receptor and a Truncated EGFR for Patients With CD123+ Relapsed/Refractory Acute Myeloid Leukemia and Persistent/Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1"],"primary_completion_date":{"date":"2027-07-14","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Dose-limiting toxicity (DLT) defined as any grade 3 or higher toxicity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0","timeFrame":"28 days"},{"measure":"Incidence of adverse events as assessed by NCI CTCAE version 4.0","timeFrame":"Up to 15 years"},{"measure":"Disease response (CR or CRi)","timeFrame":"Up to 15 year post-treatment"}],"references":[{"citation":"Budde LE, Del Real MM, Song J, Stiller T, Wang Y, Aribi A, Sandhu K, Nakamura R, Marcucci EC, Wu JJ, Ng K, Clark MC, Wood B, Wagner JR, Paul J, Brown CE, Stein A, Marcucci G, Blanchard MS, Palmer J, Forman SJ. A phase 1 trial of CD123-directed chimeric antigen receptor T-cell therapy in adults with relapsed/refractory acute myeloid leukemia or blastic plasmacytoid dendritic cell neoplasm. J Hematol Oncol. 2026 Aug 7;19(1):68. doi: 10.1186/s13045-026-01833-3.","pmid":"42681647","type":"DERIVED"}],"start_date":{"date":"2015-12-15","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Genetically Modified T-cell Immunotherapy in Treating Patients With Relapsed/Refractory Acute Myeloid Leukemia and Persistent/Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm","url":"https://clinicaltrials.gov/study/NCT02159495"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct02159495"}