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The Barcelona immunologist whose team designed ARI-0001 from the hospital's own antibody and made it in-house, so a public hospital could give CAR-T at lower cost.
Manel Juan is an immunologist in the Department of Immunology at Hospital Clínic de Barcelona and FRCB-IDIBAPS, according to the affiliation on his 2026 HemaSphere paper. The AEMPS's announcement of its February 2021 authorisation of ARI-0001 says a team led by Dr Manel Juan developed the new CD19 CAR-T from the hospital's own monoclonal antibody, and quotes him on a robust, reproducible preparation method that lowers production cost so the therapy can be affordable for academic institutions. He is an author of the CART19-BE-01 and CARTBCMA-HCB-01 reports and of the 2022 Bone Marrow Transplantation article on the hospital exemption route by which ARI-0001 was authorised.
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.
Spain's use of the hospital exemption is a working model for public hospitals making cell therapies at lower cost; the paper is the account of how it was done by the people who did it.
This is the evidence behind the AEMPS's February 2021 authorisation of ARI-0001 under the hospital exemption, which let a public hospital make and give its own CAR-T to adults with relapsed acute lymphoblastic leukaemia. The fractionated dosing it introduced is the approach later used for the hospital's BCMA CAR-T.
Shares CART19-BE-01: A Multicenter Trial of ARI-0001 Cell Therapy in Patients with CD19(+) Relapsed/Refractory Malignancies, CARTBCMA-HCB-01 (ARI0002h BCMA CAR-T, Hospital Clínic de Barcelona), 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, CART19-BE-01 (ARI-0001 CAR-T, Hospital Clínic de Barcelona).
Shares CART19-BE-01: A Multicenter Trial of ARI-0001 Cell Therapy in Patients with CD19(+) Relapsed/Refractory Malignancies, CART19-BE-01 (ARI-0001 CAR-T, Hospital Clínic de Barcelona), Hospital Clínic de Barcelona / IDIBAPS.
Shares CARTBCMA-HCB-01 (ARI0002h BCMA CAR-T, Hospital Clínic de Barcelona), 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, CART19-BE-01 (ARI-0001 CAR-T, Hospital Clínic de Barcelona).
Shares The hospital exemption pathway for advanced therapies and the case of the CAR-T ARI-0001, Hospital Clínic de Barcelona / IDIBAPS.
Shares CART19-BE-01: A Multicenter Trial of ARI-0001 Cell Therapy in Patients with CD19(+) Relapsed/Refractory Malignancies, Hospital Clínic de Barcelona / IDIBAPS.
Shares CARTBCMA-HCB-01 (ARI0002h BCMA CAR-T, Hospital Clínic de Barcelona), 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.
Shares The hospital exemption pathway for advanced therapies and the case of the CAR-T ARI-0001, CARTBCMA-HCB-01 (ARI0002h BCMA CAR-T, Hospital Clínic de Barcelona), 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, CART19-BE-01 (ARI-0001 CAR-T, Hospital Clínic de Barcelona).
Shares The hospital exemption pathway for advanced therapies and the case of the CAR-T ARI-0001, CART19-BE-01: A Multicenter Trial of ARI-0001 Cell Therapy in Patients with CD19(+) Relapsed/Refractory Malignancies, CART19-BE-01 (ARI-0001 CAR-T, Hospital Clínic de Barcelona).
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