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The results of the academic CAR-T trial that Spain's regulator used to authorise a hospital-made cell therapy for adult leukaemia, which the AEMPS described as the first CAR-T developed entirely in Europe to be approved by a regulator.
Hospital Clínic de Barcelona and Hospital Sant Joan de Déu treated adults and children with relapsed or refractory CD19-positive malignancies with ARI-0001, a CD19 CAR-T cell product made at the hospital, after cyclophosphamide and fludarabine. The dose of 0.4 to 5 x 10^6 cells per kg was given at first as one infusion and later, after an amendment, split into three fractions with the full dose depending on the absence of cytokine release syndrome. Of 58 patients included, 47 were treated: 38 with acute lymphoblastic leukaemia, 8 with non-Hodgkin lymphoma and 1 with chronic lymphocytic leukaemia. The authors conclude that the safety and efficacy results are comparable with other academic or commercially available products. The trial is registered as NCT03144583.
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 Manel Juan, CART19-BE-01 (ARI-0001 CAR-T, Hospital Clínic de Barcelona), Varnimcabtagene autoleucel, Hospital Clínic de Barcelona / IDIBAPS.
Shares Julio Delgado, Manel Juan, Hospital Clínic de Barcelona / IDIBAPS, CAR-T cell therapy.
Shares Julio Delgado, Manel Juan, Hospital Clínic de Barcelona / IDIBAPS, CAR-T cell therapy.
Shares Varnimcabtagene autoleucel, Hospital Clínic de Barcelona / IDIBAPS, CAR-T cell therapy.
Shares CIBERONC (Centro de Investigación Biomédica en Red de Cáncer), CART19-BE-01 (ARI-0001 CAR-T, Hospital Clínic de Barcelona).
Shares Varnimcabtagene autoleucel, CD19, CAR-T cell therapy, Acute lymphoblastic leukaemia.
Shares CD19, CAR-T cell therapy, Acute lymphoblastic leukaemia.
Shares CD19, CAR-T cell therapy, Acute lymphoblastic leukaemia.
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