{"entity":{"id":"cartbcma-hcb-01","kind":"trial","name":"CARTBCMA-HCB-01 (ARI0002h BCMA CAR-T, Hospital Clínic de Barcelona)","aka":["CARTBCMA-HCB-01","ARI0002h pilot study","cesnicabtagene autoleucel"],"tldr":"Hospital Clínic's second home-made CAR-T, aimed at BCMA in myeloma, given in fractions with a booster dose; every treated patient responded at the interim analysis, and Spain's health service now pays for it.","summary":"CARTBCMA-HCB-01 is a single-arm academic study at five Spanish centres of ARI0002h, a humanised BCMA-directed CAR-T cell product made at Hospital Clínic de Barcelona, in adults aged 18 to 75 with relapsed or refractory multiple myeloma after at least two previous lines including a proteasome inhibitor, an immunomodulatory drug and an anti-CD38 antibody. Patients received 3 x 10^6 CAR T cells per kg in three fractions on days 0, 3 and 7, and a booster dose at least 100 days later.\n\nAt the planned interim analysis published in The Lancet Oncology in 2023, 35 patients had been enrolled and 30 treated; overall response in the first 100 days was 100%, with very good partial response or better in 24 of 30 (complete response in 15). Cytokine release syndrome occurred in 24 of 30 patients, all grade 1 or 2, and no neurotoxic events were observed; persistent grade 3 to 4 cytopenias and infections each occurred in 20 patients. The registry lists 73 participants. The Ministerio de Sanidad lists ARI0002h beside ARI-0001 as an academic CAR-T funded by the national health service.","status":"positive","asOf":"2026-11-03","links":[{"label":"ClinicalTrials.gov NCT04309981","url":"https://clinicaltrials.gov/study/NCT04309981"},{"label":"Oliver-Caldés et al., Lancet Oncol 2023","url":"https://doi.org/10.1016/S1470-2045(23)00222-X"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/37414060/"},{"label":"Ministerio de Sanidad: terapias avanzadas en el SNS","url":"https://www.sanidad.gob.es/areas/farmacia/infoMedicamentos/terapiasAvanzadas/home.htm"}],"tags":[],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":["car-t","point-of-care-cell-manufacturing"],"targets":["bcma"],"drugs":[],"companies":[],"institutions":["hospital-clinic-barcelona","isciii"],"pathways":[],"terms":["crs"],"trials":[],"people":["julio-delgado","manel-juan","maria-victoria-mateos"],"bottlenecks":[],"keyPapers":["paper-cartbcma-hcb-01-lancet-oncol-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04309981","phase":"1/2","setting":"Pilot study of the humanised BCMA-directed CAR-T ARI0002h in relapsed or refractory multiple myeloma previously treated with a proteasome inhibitor, an immunomodulatory drug and an anti-CD38 antibody","sponsor":"Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)","result":"Overall response 100% in the first 100 days in 30 treated patients, complete response in 15; no neurotoxic events at the interim analysis (Lancet Oncol 2023).","started":"2020-05-27","startedType":"actual","yearReported":2023,"enrolled":73,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/cartbcma-hcb-01/","neighbours":{"cancer":[{"id":"multiple-myeloma","kind":"cancer","name":"Multiple myeloma","route":"/cancers/multiple-myeloma/"}],"technology":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"},{"id":"point-of-care-cell-manufacturing","kind":"technology","name":"Point-of-care and decentralised cell manufacturing","route":"/technologies/point-of-care-cell-manufacturing/"}],"target":[{"id":"bcma","kind":"target","name":"BCMA","route":"/targets/bcma/"}],"institution":[{"id":"hospital-clinic-barcelona","kind":"institution","name":"Hospital Clínic de Barcelona / IDIBAPS","route":"/institutions/hospital-clinic-barcelona/"},{"id":"isciii","kind":"institution","name":"Instituto de Salud Carlos III (ISCIII)","route":"/institutions/isciii/"}],"term":[{"id":"crs","kind":"term","name":"Cytokine release syndrome (CRS)","route":"/terms/crs/"}],"person":[{"id":"julio-delgado","kind":"person","name":"Julio Delgado","route":"/people/julio-delgado/"},{"id":"manel-juan","kind":"person","name":"Manel Juan","route":"/people/manel-juan/"},{"id":"maria-victoria-mateos","kind":"person","name":"María-Victoria Mateos","route":"/people/maria-victoria-mateos/"}],"paper":[{"id":"paper-cartbcma-hcb-01-lancet-oncol-2023","kind":"paper","name":"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","route":"/key-papers/paper-cartbcma-hcb-01-lancet-oncol-2023/"}]}}