# 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

Source: https://onco.cc/key-papers/paper-cartbcma-hcb-01-lancet-oncol-2023/  
OnCo record `paper-cartbcma-hcb-01-lancet-oncol-2023` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The interim results of Hospital Clínic's academic BCMA CAR-T for myeloma: every one of 30 treated patients responded in the first 100 days, with no neurotoxic events.

## Summary

CARTBCMA-HCB-01 is a single-arm study at five academic centres in Spain of ARI0002h, a humanised BCMA-directed CAR-T made by an academic centre, in adults aged 18 to 75 with relapsed or refractory multiple myeloma previously treated with a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody and refractory to the last line. Patients received a fractionated initial infusion of 3 x 10^6 CAR T cells per kg over days 0, 3 and 7 and a non-fractionated booster at least 100 days later. Between 2 June 2020 and 24 February 2021, 44 patients were assessed and 35 enrolled; 30 received ARI0002h. The study was funded by the Instituto de Salud Carlos III (co-funded by the EU), Fundación La Caixa and Fundació Bosch i Aymerich, and is registered as NCT04309981.

## Fields

- Kind: Key paper
- Last checked: 2026-11-03
- Journal: The Lancet Oncology
- Year: 2023
- DOI: 10.1016/S1470-2045(23)00222-X
- Authors: Oliver-Caldés A, González-Calle V, Cabañas V, et al.
- Findings: Overall response during the first 100 days was 100% in 30 treated patients: 15 complete responses, 9 very good partial responses and 6 partial responses.; Cytokine release syndrome occurred in 24 of 30 patients (80%), all grade 1 or 2; no neurotoxic events were observed.; Persistent grade 3 to 4 cytopenias occurred in 20 patients (67%) and infections in 20 (67%).; Three patients died: one from progression, one from a head injury and one from COVID-19. Median follow-up was 12.1 months.
- What it means: 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.
- Caveats: Interim analysis of a single-arm study with 30 treated patients and about a year of follow-up; durability needs the final analysis.; Response rates in single-arm studies are not directly comparable with randomised trials of commercial products.

## Sources

- Lancet Oncol 2023: https://doi.org/10.1016/S1470-2045(23)00222-X
- PubMed: https://pubmed.ncbi.nlm.nih.gov/37414060/

## Connected records

- cancers: [Multiple myeloma](https://onco.cc/cancers/multiple-myeloma/)
- technologies: [CAR-T cell therapy](https://onco.cc/technologies/car-t/), [Point-of-care and decentralised cell manufacturing](https://onco.cc/technologies/point-of-care-cell-manufacturing/)
- targets: [BCMA](https://onco.cc/targets/bcma/)
- institutions: [Hospital Clínic de Barcelona / IDIBAPS](https://onco.cc/institutions/hospital-clinic-barcelona/), [Instituto de Salud Carlos III (ISCIII)](https://onco.cc/institutions/isciii/)
- trials: [CARTBCMA-HCB-01 (ARI0002h BCMA CAR-T, Hospital Clínic de Barcelona)](https://onco.cc/trials/cartbcma-hcb-01/)
- people: [Julio Delgado](https://onco.cc/people/julio-delgado/), [Manel Juan](https://onco.cc/people/manel-juan/), [María-Victoria Mateos](https://onco.cc/people/maria-victoria-mateos/)
- journals: [The Lancet Oncology](https://onco.cc/journals/lancet-oncology/)

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