{"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},"name":"NCT04309981","nct_id":"NCT04309981","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct04309981. 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":"Adult differentiated autologous T-cells from peripheral blood, expanded and transducted with a lentivirus to express a chimeric antigen receptor with anti-BCMA (TNFRSF17) specificity conjugated to the 4-1BB co-stimulatory region and signal-transduction CD3z that has been humanized","label":"ARI0002h","type":"EXPERIMENTAL"}],"collaborators":["Fondos ARI (Assistencia Recerca Intensiva)","Instituto de Salud Carlos III","La Caixa Foundation"],"completion_date":{"date":"2025-04-01","type":"ESTIMATED"},"conditions":["Relapsed/Refractory Multiple Myeloma"],"enrollment":{"count":73,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Adult differentiated autologous T-cells with anti-BCMA specificity","otherNames":["CARTBCMA"],"type":"BIOLOGICAL"}],"last_update":"2023-08-28","lead_sponsor":"Sara V. Latorre","official_title":"Pilot Study of the Infusion of Differentiated Autologous T-cells From Peripheral Blood, Expanded and Transduced With a Lentivirus to Express a Chimeric Antigen Receptor With Anti-BCMA (TNFRSF17) Specificity Humanized Conjugated With the Co-stimulatory Region 4-1BB and Signal-transduction CD3z (ARI0002h) in Patients With Relapsed/Refractory Multiple Myeloma With Previous Treatment With Proteasome Inhibitor, Immunomodulatory Drug and Anti-CD38 Monoclonal Antibody","overall_status":"UNKNOWN","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2025-04-01","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Overall response rate (ORR)","timeFrame":"3 months"},{"measure":"Cytokine release syndrome rate","timeFrame":"within 30 days of first infusion"}],"references":[{"citation":"Zugasti I, Tormo-Ratera M, Oliver-Caldes A, Soler-Perromat JC, Gonzalez-Calle V, Moreno DF, Cabanas V, Lopez-Munoz N, Bartolome-Solanas A, Espanol-Rego M, Reguera-Ortega JL, Rosinol L, Lopez-Corral L, Tovar N, Rodriguez-Lobato LG, Alvarez Perez RM, Varea S, Olesti E, Gomez-Grande A, Frutos L, Tamayo P, Juan M, Moraleda JM, Urbano-Ispizua A, Gonzalez-Navarro EA, Martinez-Lopez J, Mateos MV, Tomas X, Setoain X, Fernandez de Larrea C. Clinical impact of [18F]FDG-PET/CT in ARI0002h treatment, a CAR-T against BCMA for relapsed/refractory multiple myeloma. Blood Adv. 2025 Feb 11;9(3):571-582. doi: 10.1182/bloodadvances.2024014360.","pmid":"39602341","type":"DERIVED"},{"citation":"Oliver-Caldes A, Gonzalez-Calle V, Cabanas V, Espanol-Rego M, Rodriguez-Otero P, Reguera JL, Lopez-Corral L, Martin-Antonio B, Zabaleta A, Inoges S, Varea S, Rosinol L, Lopez-Diaz de Cerio A, Tovar N, Jimenez R, Lopez-Parra M, Rodriguez-Lobato LG, Sanchez-Salinas A, Olesti E, Calvo-Orteu M, Delgado J, Perez-Simon JA, Paiva B, Prosper F, Saez-Penataro J, Juan M, Moraleda JM, Mateos MV, Pascal M, Urbano-Ispizua A, Fernandez de Larrea C. Fractionated initial infusion and booster dose of ARI0002h, a humanised, BCMA-directed CAR T-cell therapy, for patients with relapsed or refractory multiple myeloma (CARTBCMA-HCB-01): a single-arm, multicentre, academic pilot study. Lancet Oncol. 2023 Aug;24(8):913-924. doi: 10.1016/S1470-2045(23)00222-X. Epub 2023 Jul 3.","pmid":"37414060","type":"DERIVED"},{"citation":"Oliver-Caldes A, Jimenez R, Espanol-Rego M, Cibeira MT, Ortiz-Maldonado V, Quintana LF, Castillo P, Guijarro F, Tovar N, Montoro M, Benitez-Ribas D, Bataller A, Gonzalez-Navarro EA, Cid J, Lozano M, Perez-Amill L, Martin-Antonio B, Mena MP, Moreno DF, Rodriguez-Lobato LG, Campistol JM, Calvo G, Blade J, Rosinol L, Juan M, Pascal M, Urbano-Ispizua A, Fernandez de Larrea C. First report of CART treatment in AL amyloidosis and relapsed/refractory multiple myeloma. J Immunother Cancer. 2021 Dec;9(12):e003783. doi: 10.1136/jitc-2021-003783.","pmid":"34876408","type":"DERIVED"}],"start_date":{"date":"2020-05-27","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Clinical Trial Using Humanized CART Directed Against BCMA (ARI0002h) in Patients With Relapsed/Refractory Multiple Myeloma to Proteasome Inhibitors, Immunomodulators and Anti-CD38 Antibody.","url":"https://clinicaltrials.gov/study/NCT04309981"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct04309981"}