{"commentary":{"count":73,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":37,"x_thread":19,"podcast":17},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT03331198\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"NCT03331198","nct_id":"NCT03331198","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03331198. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1950,"size":"deep","size_rule":"Deep: 41+ commentary sources"},"registry":{"acronym":null,"arms":[{"description":"Subjects will be assigned to receive JCAR017 (lisocabtagene maraleucel)","label":"Phase 1 JCAR017 monotherapy","type":"EXPERIMENTAL"},{"description":"Subjects receiving ibrutinib at baseline will be assigned to receive JCAR017 (lisocabtagene maraleucel) at the recommended dose from the Phase 1 monotherapy arm + ibrutinib","label":"Phase 1 JCAR017 + ibrutinib","type":"EXPERIMENTAL"},{"description":"Subjects will receive JCAR017 (lisocabtagene maraleucel) at the recommended dose from the Phase 1 monotherapy arm","label":"Phase 2 JCAR017 monotherapy","type":"EXPERIMENTAL"},{"description":"Subjects will receive venetoclax as bridging anticancer therapy until lymphodepletion chemotherapy/ JCAR017 (lisocabtagene maraleucel) at the recommended dose from the Phase 1 monotherapy arm. After JCAR017 infusion subjects will receive venetoclax until Day 90.","label":"Phase 1 JCAR017 + venetoclax","type":"EXPERIMENTAL"},{"description":"Subjects will receive JCAR017 monotherapy","label":"Phase 2 JCAR017 Double-Exposed Monotherapy Expansion (DEME)","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2027-11-26","type":"ESTIMATED"},"conditions":["Leukemia, Lymphocytic, Chronic, B-Cell","Lymphoma, Small Lymphocytic"],"enrollment":{"count":320,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"JCAR017 (lisocabtagene maraleucel)","type":"BIOLOGICAL"},{"name":"JCAR017 (lisocabtagene maraleucel) + ibrutinib","type":"BIOLOGICAL"},{"name":"JCAR017 (lisocabtagene maraleucel) + venetoclax","type":"BIOLOGICAL"}],"last_update":"2026-07-06","lead_sponsor":"Juno Therapeutics, a Subsidiary of Celgene","official_title":"An Open-Label, Phase 1/2 Study of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (017004)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2027-11-26","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Phase 1 JCAR017 monotherapy arm: adverse events","timeFrame":"Up to 48 months post treatment"},{"measure":"Phase 1 JCAR017 monotherapy arm: laboratory abnormalities","timeFrame":"Up to 48 months post treatment"},{"measure":"Phase 1 JCAR017 and ibrutinib combination dose escalation therapy arm: adverse events","timeFrame":"Up to 48 months post treatment"},{"measure":"Phase 1 JCAR017 and ibrutinib combination dose escalation therapy arm: laboratory abnormalities","timeFrame":"Up to 48 months post treatment"},{"measure":"Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm","timeFrame":"Through post treatment up to Month 48"},{"measure":"Phase 1 JCAR017 and venetoclax combination dose escalation therapy arm: adverse events","timeFrame":"Up to 48 months post treatment"},{"measure":"Phase 1 JCAR017 and venetoclax combination dose escalation therapy arm: laboratory abnormalities","timeFrame":"Up to 48 months post treatment"},{"measure":"Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm","timeFrame":"Through post treatment up to Month 48"},{"measure":"Phase 2 JCAR017 monotherapy expansion arm","timeFrame":"Through post treatment up to Month 48"},{"measure":"Phase 2 JCAR017 Double exposed monotherapy expansion arm: overall response rate (ORR)","timeFrame":"Up to approximately 24 months"}],"references":[{"citation":"Wierda WG, Dorritie KA, Gauthier J, Nath R, Kipps TJ, Riedell PA, Eradat HA, Kenderian SS, Kharfan-Dabaja MA, Shah NN, Solomon SR, Stephens DM, Ermann DA, Arnason JE, Deol A, Feldman TA, Andreadis CB, Ghosh M, Ma S, Schuster SJ, Gergis U, Vose JM, Soumerai JD, van Besien K, Tuazon SA, Perna SK, Ou SS, Ananthakrishnan R, Rane N, Papp E, Ansari S, Thompson EG, Okal A, Peiser L, Chen Y, Sengupta S, Ray PR, Wang J, Siddiqi T. Lisocabtagene maraleucel combined with ibrutinib in R/R CLL or SLL: primary results from TRANSCEND CLL 004. Blood. 2026 Jul 28:blood.2026033565. doi: 10.1182/blood.2026033565. Online ahead of print.","pmid":"42520199","type":"DERIVED"},{"citation":"Siddiqi T, Maloney DG, Kenderian SS, Brander DM, Dorritie K, Soumerai J, Riedell PA, Shah NN, Nath R, Fakhri B, Stephens DM, Ma S, Feldman T, Solomon SR, Schuster SJ, Perna SK, Tuazon SA, Ou SS, Papp E, Peiser L, Chen Y, Wierda WG. Lisocabtagene maraleucel in chronic lymphocytic leukaemia and small lymphocytic lymphoma (TRANSCEND CLL 004): a multicentre, open-label, single-arm, phase 1-2 study. Lancet. 2023 Aug 19;402(10402):641-654. doi: 10.1016/S0140-6736(23)01052-8. Epub 2023 Jun 6.","pmid":"37295445","type":"DERIVED"},{"citation":"Teoh J, Brown LF. Developing lisocabtagene maraleucel chimeric antigen receptor T-cell manufacturing for improved process, product quality and consistency across CD19+ hematologic indications. Cytotherapy. 2022 Sep;24(9):962-973. doi: 10.1016/j.jcyt.2022.03.013. Epub 2022 May 21.","pmid":"35610089","type":"DERIVED"},{"citation":"Siddiqi T, Soumerai JD, Dorritie KA, Stephens DM, Riedell PA, Arnason J, Kipps TJ, Gillenwater HH, Gong L, Yang L, Ogasawara K, Thorpe J, Wierda WG. Phase 1 TRANSCEND CLL 004 study of lisocabtagene maraleucel in patients with relapsed/refractory CLL or SLL. Blood. 2022 Mar 24;139(12):1794-1806. doi: 10.1182/blood.2021011895.","pmid":"34699592","type":"DERIVED"}],"start_date":{"date":"2017-11-27","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)","url":"https://clinicaltrials.gov/study/NCT03331198"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct03331198"}