{"entity":{"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","aka":[],"tldr":"The interim results of Hospital Clínic's academic BCMA CAR-T for myeloma: every one of 30 treated patients responded in the first 100 days, with no neurotoxic events.","summary":"CARTBCMA-HCB-01 is a single-arm study at five academic centres in Spain of ARI0002h, a humanised BCMA-directed CAR-T made by an academic centre, in adults aged 18 to 75 with relapsed or refractory multiple myeloma previously treated with a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody and refractory to the last line. Patients received a fractionated initial infusion of 3 x 10^6 CAR T cells per kg over days 0, 3 and 7 and a non-fractionated booster at least 100 days later. Between 2 June 2020 and 24 February 2021, 44 patients were assessed and 35 enrolled; 30 received ARI0002h. The study was funded by the Instituto de Salud Carlos III (co-funded by the EU), Fundación La Caixa and Fundació Bosch i Aymerich, and is registered as NCT04309981.","asOf":"2026-11-03","links":[{"label":"Lancet Oncol 2023","url":"https://doi.org/10.1016/S1470-2045(23)00222-X"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/37414060/"}],"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":[],"trials":["cartbcma-hcb-01"],"people":["julio-delgado","manel-juan","maria-victoria-mateos"],"bottlenecks":[],"keyPapers":[],"journals":["lancet-oncology"],"dependsOn":[],"notes":[],"journal":"The Lancet Oncology","year":2023,"doi":"10.1016/S1470-2045(23)00222-X","pmid":"37414060","authors":"Oliver-Caldés A, González-Calle V, Cabañas V, et al.","paperType":"observational","findings":["Overall response during the first 100 days was 100% in 30 treated patients: 15 complete responses, 9 very good partial responses and 6 partial responses.","Cytokine release syndrome occurred in 24 of 30 patients (80%), all grade 1 or 2; no neurotoxic events were observed.","Persistent grade 3 to 4 cytopenias occurred in 20 patients (67%) and infections in 20 (67%).","Three patients died: one from progression, one from a head injury and one from COVID-19. Median follow-up was 12.1 months."],"whatItMeans":"An academic hospital can make a BCMA CAR-T on site and give it with low rates of severe toxicity. Spain's health service now funds ARI0002h beside the commercial BCMA products, which makes the price and supply of a hospital-made product a live comparison rather than a hypothesis.","caveats":["Interim analysis of a single-arm study with 30 treated patients and about a year of follow-up; durability needs the final analysis.","Response rates in single-arm studies are not directly comparable with randomised trials of commercial products."],"participants":30},"route":"/key-papers/paper-cartbcma-hcb-01-lancet-oncol-2023/","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/"}],"trial":[{"id":"cartbcma-hcb-01","kind":"trial","name":"CARTBCMA-HCB-01 (ARI0002h BCMA CAR-T, Hospital Clínic de Barcelona)","route":"/trials/cartbcma-hcb-01/"}],"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/"}],"journal":[{"id":"lancet-oncology","kind":"journal","name":"The Lancet Oncology","route":"/journals/lancet-oncology/"}]}}