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.
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.
At 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.
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.
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/