{"preliminary_commentary":{"by_channel":{"x_thread":2,"bluesky_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":null,"indication":null,"name":"NCT03233854","nct_id":"NCT03233854","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03233854. 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":"Patients receive cyclophosphamide IV over 60 minutes and fludarabine phosphate IV over 30 minutes on days -5 to -3. Patients then receive CD19/CD22 CAR T cells IV over 10-20 minutes on day 0. On Day 14 after CAR-T, eligible patients will be given NKTR-255 IV over 30 minutes, and it will be repeated every 28 days for up to 6 cycles. Patients that benefited from the first dose of CD19/CD22 CAR T cells, had no unacceptable side effects, and have enough cells left over may receive 2 or 3 additional doses of CD19/CD22 CAR T cells.","label":"Treatment (CD19/CD22 CAR T cells, chemotherapy, NKTR-255)","type":"EXPERIMENTAL"}],"collaborators":["California Institute for Regenerative Medicine (CIRM)"],"completion_date":{"date":"2035-09-01","type":"ESTIMATED"},"conditions":["B Acute Lymphoblastic Leukemia","CD19 Positive","Minimal Residual Disease","Philadelphia Chromosome Positive"],"enrollment":{"count":56,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Chimeric Antigen Receptor T-Cell Therapy","otherNames":["CAR T-cell therapy"],"type":"BIOLOGICAL"},{"name":"Cyclophosphamide","otherNames":["(-)-Cyclophosphamide","2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate","Carloxan","Ciclofosfamida","Ciclofosfamide","Cicloxal","Clafen","Claphene","CP monohydrate","CTX","CYCLO-cell","Cycloblastin","Cycloblastine","Cyclophospham","Cyclophosphamid monohydrate","Cyclophosphamidum","Cyclophosphan","Cyclophosphane","Cyclophosphanum","Cyclostin","Cyclostine","Cytophosphan","Cytophosphane","Cytoxan","Fosfaseron","Genoxal","Genuxal","Ledoxina","Mitoxan","Neosar","Revimmune","Syklofosfamid","WR- 138719"],"type":"DRUG"},{"name":"Fludarabine Phosphate","otherNames":["2-F-ara-AMP","9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-.beta.-D-arabinofuranosyl)-","Beneflur","Fludara","SH T 586"],"type":"DRUG"},{"name":"Laboratory Biomarker Analysis","otherNames":[],"type":"OTHER"},{"name":"Questionnaire Administration","otherNames":[],"type":"OTHER"},{"name":"NKTR-255","otherNames":[],"type":"DRUG"}],"last_update":"2025-11-18","lead_sponsor":"Stanford University","official_title":"Phase 1 Dose Escalation Study of CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells With or Without NKTR-255 in Adults With Recurrent or Refractory B Cell Malignancies","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1"],"primary_completion_date":{"date":"2023-06-20","type":"ACTUAL"},"primary_outcomes":[{"measure":"Incidence and severity of dose limiting toxicities (DLTs) following chemotherapy preparative regimen and infusion of CD19/CD22 chimeric antigen receptor (CAR) T cells","timeFrame":"Up to 28 days"},{"measure":"Maximum tolerated dose of CD19/CD22 chimeric antigen receptor (CAR) T cells defined as the dose level immediately below the level at which the enrollment is stopped due to a dose limiting toxicity","timeFrame":"Up to 28 days"},{"measure":"Rate of successful manufacture and expansion of the CD19/CD22 chimeric antigen receptor (CAR) T cells to satisfy the targeted dose level and meet the required release specifications outlined in the Certificate of Analysis","timeFrame":"Up to 15 years"}],"references":[{"citation":"Srinagesh H, Jackson C, Shiraz P, Jeyakumar N, Hamilton M, Egeler E, Mavroukakis S, Kuo A, Cancilla J, Sahaf B, Agarwal N, Kanegai A, Kramer AM, Arai S, Bharadwaj S, Dahiya S, Hosoya H, Johnston L, Kennedy V, Liedtke M, Lowsky R, Mikkilineni L, Negrin R, Rezvani A, Sidana S, Shizuru J, Smith M, Weng WK, Feldman S, Frank MJ, Lee Z, Tagliaferri M, Marcondes AM, Miklos D, Mackall C, Muffly L. A phase 1 clinical trial of NKTR-255 with CD19-22 CAR T-cell therapy for refractory B-cell acute lymphoblastic leukemia. Blood. 2024 Oct 17;144(16):1689-1698. doi: 10.1182/blood.2024024952.","pmid":"38968138","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":"Spiegel JY, Patel S, Muffly L, Hossain NM, Oak J, Baird JH, Frank MJ, Shiraz P, Sahaf B, Craig J, Iglesias M, Younes S, Natkunam Y, Ozawa MG, Yang E, Tamaresis J, Chinnasamy H, Ehlinger Z, Reynolds W, Lynn R, Rotiroti MC, Gkitsas N, Arai S, Johnston L, Lowsky R, Majzner RG, Meyer E, Negrin RS, Rezvani AR, Sidana S, Shizuru J, Weng WK, Mullins C, Jacob A, Kirsch I, Bazzano M, Zhou J, Mackay S, Bornheimer SJ, Schultz L, Ramakrishna S, Davis KL, Kong KA, Shah NN, Qin H, Fry T, Feldman S, Mackall CL, Miklos DB. CAR T cells with dual targeting of CD19 and CD22 in adult patients with recurrent or refractory B cell malignancies: a phase 1 trial. Nat Med. 2021 Aug;27(8):1419-1431. doi: 10.1038/s41591-021-01436-0. Epub 2021 Jul 26.","pmid":"34312556","type":"DERIVED"}],"start_date":{"date":"2017-09-01","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells With or Without NKTR-255 in Adults With Recurrent or Refractory B Cell Malignancies","url":"https://clinicaltrials.gov/study/NCT03233854"},"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/nct03233854"}