# CARTBCMA-HCB-01 (ARI0002h BCMA CAR-T, Hospital Clínic de Barcelona)

Source: https://onco.cc/trials/cartbcma-hcb-01/  
OnCo record `cartbcma-hcb-01` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Hospital Clínic's second home-made CAR-T, aimed at BCMA in myeloma, given in fractions with a booster dose; every treated patient responded at the interim analysis, and Spain's health service now pays for it.

## Summary

CARTBCMA-HCB-01 is a single-arm academic study at five Spanish centres of ARI0002h, a humanised BCMA-directed CAR-T cell product made at Hospital Clínic de Barcelona, in adults aged 18 to 75 with relapsed or refractory multiple myeloma after at least two previous lines including a proteasome inhibitor, an immunomodulatory drug and an anti-CD38 antibody. Patients received 3 x 10^6 CAR T cells per kg in three fractions on days 0, 3 and 7, and a booster dose at least 100 days later.

At the planned interim analysis published in The Lancet Oncology in 2023, 35 patients had been enrolled and 30 treated; overall response in the first 100 days was 100%, with very good partial response or better in 24 of 30 (complete response in 15). Cytokine release syndrome occurred in 24 of 30 patients, all grade 1 or 2, and no neurotoxic events were observed; persistent grade 3 to 4 cytopenias and infections each occurred in 20 patients. The registry lists 73 participants. The Ministerio de Sanidad lists ARI0002h beside ARI-0001 as an academic CAR-T funded by the national health service.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-11-03
- Also known as: CARTBCMA-HCB-01; ARI0002h pilot study; cesnicabtagene autoleucel
- Registry id: NCT04309981
- Phase: 1/2
- Setting: Pilot study of the humanised BCMA-directed CAR-T ARI0002h in relapsed or refractory multiple myeloma previously treated with a proteasome inhibitor, an immunomodulatory drug and an anti-CD38 antibody
- Sponsor: Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)
- Enrolled: 73
- Result: Overall response 100% in the first 100 days in 30 treated patients, complete response in 15; no neurotoxic events at the interim analysis (Lancet Oncol 2023).

## Sources

- ClinicalTrials.gov NCT04309981: https://clinicaltrials.gov/study/NCT04309981
- Oliver-Caldés et al., Lancet Oncol 2023: https://doi.org/10.1016/S1470-2045(23)00222-X
- PubMed: https://pubmed.ncbi.nlm.nih.gov/37414060/
- Ministerio de Sanidad: terapias avanzadas en el SNS: https://www.sanidad.gob.es/areas/farmacia/infoMedicamentos/terapiasAvanzadas/home.htm

## 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/)
- terms: [Cytokine release syndrome (CRS)](https://onco.cc/terms/crs/)
- 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/)
- key papers: [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](https://onco.cc/key-papers/paper-cartbcma-hcb-01-lancet-oncol-2023/)

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