American Association for Cancer Research

Data from Biomarkers of Efficacy and Safety of the Academic BCMA-CART ARI0002h for the Treatment of Refractory Multiple Myeloma

Posted on 2024-05-15 - 07:22

B-cell maturation antigen (BCMA)-chimeric antigen receptor T-cells (CART) improve results obtained with conventional therapy in the treatment of relapsed/refractory multiple myeloma. However, the high demand and expensive costs associated with CART therapy might prove unsustainable for health systems. Academic CARTs could potentially overcome these issues. Moreover, response biomarkers and resistance mechanisms need to be identified and addressed to improve efficacy and patient selection. Here, we present clinical and ancillary results of the 60 patients treated with the academic BCMA-CART, ARI0002h, in the CARTBCMA-HCB-01 trial.

Patients and Methods:

We collected apheresis, final product, peripheral blood and bone marrow samples before and after infusion. We assessed BCMA, T-cell subsets, CART kinetics and antibodies, B-cell aplasia, cytokines, and measurable residual disease by next-generation flow cytometry, and correlated these to clinical outcomes.


At cut-off date March 17, 2023, with a median follow-up of 23.1 months (95% CI, 9.2–37.1), overall response rate in the first 3 months was 95% [95% confidence interval (CI), 89.5–100]; cytokine release syndrome (CRS) was observed in 90% of patients (5% grades ≥3) and grade 1 immune effector cell-associated neurotoxicity syndrome was reported in 2 patients (3%). Median progression-free survival was 15.8 months (95% CI, 11.5–22.4). Surface BCMA was not predictive of response or survival, but soluble BCMA correlated with worse clinical outcomes and CRS severity. Activation marker HLA-DR in the apheresis was associated with longer progression-free survival and increased exhaustion markers correlated with poorer outcomes. ARI0002h kinetics and loss of B-cell aplasia were not predictive of relapse.


Despite deep and sustained responses achieved with ARI0002h, we identified several biomarkers that correlate with poor outcomes.


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Instituto de Salud Carlos III (ISCIII)

'la Caixa' Foundation ('la Caixa')

Fundación Científica Asociación Española Contra el Cáncer (AECC)



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Aina Oliver-Caldes
Marta Español-Rego
Aintzane Zabaleta
Verónica González-Calle
Sergio Navarro-Velázquez
Susana Inogés
Ascensión López-Díaz de Cerio
Valentín Cabañas
Nieves López-Muñoz
Paula Rodríguez-Otero
Juan Luis Reguera
David F. Moreno
Nuria Martínez-Cibrian
Lucía López-Corral
Lorena Pérez-Amill
Beatriz Martin-Antonio
Laura Rosiñol
Joan Cid
Natalia Tovar
Joaquín Sáez-Peñataro
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