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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.
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.
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.
Shares Julio Delgado, Instituto de Salud Carlos III (ISCIII), Manel Juan, Point-of-care and decentralised cell manufacturing.
Shares Manel Juan, Point-of-care and decentralised cell manufacturing, Hospital Clínic de Barcelona / IDIBAPS, CAR-T cell therapy.
Shares Julio Delgado, Manel Juan, Hospital Clínic de Barcelona / IDIBAPS, CAR-T cell therapy.
Shares Instituto de Salud Carlos III (ISCIII), Hospital Clínic de Barcelona / IDIBAPS.
Shares María-Victoria Mateos, Multiple myeloma.
Shares BCMA, CAR-T cell therapy, Multiple myeloma.
Shares BCMA, CAR-T cell therapy, Multiple myeloma.
Shares BCMA, CAR-T cell therapy, Multiple myeloma.
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