دورية أكاديمية
Fractionated initial infusion and booster dose of ARI0002h, a humanised, BCMA-directed CART-cell therapy, for patients with relapsed or refractory multiple myeloma (CARTBCMA- HCB-01): a single-arm, multicentre, academic pilot study
| العنوان: | Fractionated initial infusion and booster dose of ARI0002h, a humanised, BCMA-directed CART-cell therapy, for patients with relapsed or refractory multiple myeloma (CARTBCMA- HCB-01): a single-arm, multicentre, academic pilot study |
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| المؤلفون: | Oliver Caldés, Aina, González Calle, Verónica, Cabañas, Valentín, Español Rego, Marta, Rodríguez Otero, Paula, Reguera, Juan Luis, López Corral, Lucía, Martin Antonio, Beatriz, Zabaleta, Aintzane, Inogés, Susana, Varea, Sara, Rosiñol, Laura, López-Díaz de Cerio, Ascensión, Tovar, Natalia, Jiménez, Raquel, López Parra, Miriam, Rodríguez Lobato, Luis Gerardo, Sánchez Salinas, Andrés, Olesti, Eulàlia, Calvo Orteu, Maria, Delgado, Julio, Pérez Simón, José Antonio, Paiva, Bruno, Prósper, Felipe, Sáez Peñataro, Joaquín, Juan, Manel E., Moraleda, José M., Mateos, María-Victoria, Pascal, Mariona, Urbano Ispizua, Álvaro, Fernández de Larrea, Carlos |
| المصدر: | Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer) |
| بيانات النشر: | Elsevier Ltd |
| سنة النشر: | 2023 |
| المجموعة: | Dipòsit Digital de la Universitat de Barcelona |
| مصطلحات موضوعية: | COVID-19, Citocines, Cytokines |
| الوصف: | Background Chimeric antigen receptor (CAR) T-cell therapy is a promising option for patients with heavily treated multiple myeloma. Point-of-care manufacturing can increase the availability of these treatments worldwide. We aimed to assess the safety and activity of ARI0002h, a BCMA-targeted CAR T-cell therapy developed by academia, in patients with relapsed or refractory multiple myeloma. Methods CARTBCMA-HCB-01 is a single-arm, multicentre study done in five academic centres in Spain. Eligible patients had relapsed or refractory multiple myeloma and were aged 18-75 years; with an Eastern Cooperative Oncology Group performance status of 0-2; two or more previous lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody; refractoriness to the last line of therapy; and measurable disease according to the International Myeloma Working Group criteria. Patients received an initial fractionated infusion of 3 x 106 CAR T cells per kg bodyweight in three aliquots (0 & BULL;3, 0 & BULL;9, and 1 & BULL;8 x 106 CAR-positive cells per kg intravenously on days 0, 3, and 7) and a non-fractionated booster dose of up to 3 x 106 CAR T cells per kg bodyweight, at least 100 days after the first infusion. The primary endpoints were overall response rate 100 days after first infusion and the proportion of patients developing cytokine-release syndrome or neurotoxic events in the first 30 days after receiving treatment. Here, we present an interim analysis of the ongoing trial; enrolment has ended. This study is registered with ClinicalTrials.gov, NCT04309981, and EudraCT, 2019-001472-11. Findings Between June 2, 2020, and Feb 24, 2021, 44 patients were assessed for eligibility, of whom 35 (80%) were enrolled. 30 (86%) of 35 patients received ARI0002h (median age 61 years [IQR 53-65], 12 [40%] were female, and 18 [60%] were male). At the planned interim analysis (cutoff date Oct 20, 2021), with a median follow-up of 12 & BULL;1 months (IQR 9 & BULL;1-13 & BULL;5), ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | 19 p.; application/pdf |
| اللغة: | English |
| تدمد: | 1470-2045 |
| العلاقة: | Reproducció del document publicat a: https://doi.org/10.1016/S1470-2045Test(23)00222-X; Lancet Oncology, 2023, vol. 24, num. 8, p. 913-924; https://doi.org/10.1016/S1470-2045Test(23)00222-X; http://hdl.handle.net/2445/207544Test; 9380237 |
| الإتاحة: | https://doi.org/10.1016/S1470-2045Test(23)00222-X http://hdl.handle.net/2445/207544Test |
| حقوق: | cc by-nc-nd (c) Elsevier, 2023 ; http://creativecommons.org/licenses/by-nc-nd/3.0/esTest/ ; info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.80DA5D26 |
| قاعدة البيانات: | BASE |
| تدمد: | 14702045 |
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